Take an Assessment!

Quickly see how your passions and skills match with available careers and fields of interest!

Health Sciences

Clinical Research Coordinators

Plan, direct, or coordinate clinical research projects.

A Day In The Life

Health Sciences Field of Interest

Are you interested in training?

Sign up or Sign in to contact a Coach.

Salary Breakdown

Clinical Research Coordinators

Average

$133,350

ANNUAL

$64.11

HOURLY

Entry Level

$75,170

ANNUAL

$36.14

HOURLY

Mid Level

$113,630

ANNUAL

$54.63

HOURLY


Supporting Programs

Clinical Research Coordinators

Sort by:

No Results

Current Available & Projected Jobs

Clinical Research Coordinators

19

Current Available Jobs

880

Projected job openings through 2030


Top Expected Tasks

Clinical Research Coordinators


Knowledge, Skills & Abilities

Clinical Research Coordinators

Common knowledge, skills & abilities needed to get a foot in the door.

KNOWLEDGE

Customer and Personal Service

KNOWLEDGE

English Language

KNOWLEDGE

Administrative

KNOWLEDGE

Medicine and Dentistry

KNOWLEDGE

Administration and Management

SKILL

Active Listening

SKILL

Reading Comprehension

SKILL

Writing

SKILL

Coordination

SKILL

Speaking

ABILITY

Deductive Reasoning

ABILITY

Oral Comprehension

ABILITY

Oral Expression

ABILITY

Problem Sensitivity

ABILITY

Written Comprehension


Job Opportunities

Clinical Research Coordinators

  • Structural Heart Clinical Research Coordinator
    Banner Health    Phoenix, AZ 85067
     Posted 2 days    

    **Primary City/State:**

    Phoenix, Arizona

    **Department Name:**

    BUMCP Cardiovascular

    **Work Shift:**

    Day

    **Job Category:**

    Research

    The academic medicine difference. At the center of Banner – University Medicine is patient care, research, and teaching. Join a nationally recognized health care leader and experience the future of medicine today.

    The Banner University Heart Institute cares for a high volume of heart disease patients throughout the state of Arizona and the southwest. Our physicians stand out as being active participants in national research and as providers of cardiac training to physicians from all over the United States and the world. Our goal is to offer patients excellent cardiac services by providing safe, compassionate care and the best advanced treatment options.

    As a Structural Heart Coordinator on this team, you will be an integral part of the patient's Banner experience looking to provide each person with the best customer service and patient care, you will coordinate scheduling and prepare for research visits, interview and evaluate potential participants to ensure they meet eligibility requirements, instruct participants concerning protocol responsibilities and obtain consent signature, create and file adequate source documentation, accurate and timely data reporting, and perform quality checks. Be part of an academic center partnered with U of A, with careeer growth within organization, and continued training and education.

    This is a full time (40 hours/week), day shift position: Monday - Friday 800A-4:30P

    University Medical Center Phoenix is a nationally recognized academic medical center. The world-class hospital is focused on coordinated clinical care, expanded research activities and nurturing future generations of highly trained medical professionals. Our commitment to nursing excellence has enabled us to achieve Magnet™ recognition by the American Nurses Credentialing Center. The Phoenix campus, long known for excellent patient care, has over 730 licensed beds, several unique specialty units and is the new home for medical discoveries, thanks to our collaboration with the University of Arizona College of Medicine - Phoenix. Additionally, the campus responsibilities include fully integrated multi-specialty and sub-specialty clinics and has operations in multiple locations spanning across the Phoenix metropolitan city.

    POSITION SUMMARY

    This position is responsible for coordinating and/or implementing assigned protocols. This position includes collecting and recording medical data and history, assisting in patient assessments, and maintaining study files.

    CORE FUNCTIONS

    1. Provides study information and obtains relevant information to and from patients engaged in clinical studies, which includes: assisting in the recruitment and screening of volunteers; registering patients; providing information on clinical trials and protocols to interested participants in a timely and helpful manner; obtaining relevant medical history on candidates by phone and in person; collecting previous relevant medical records data on patient; explaining procedures and consent forms; compiling all information prior to the initial visit; responding to inquiries from study participants or collateral informants in a timely and helpful manner; updating databases with patient information; and/or, performing other related activities.

    2. Performs tasks required by protocol, which may include obtaining patient medical history, systems review, phlebotomy, EKG, and cognitive assessment on patients. Collects vital signs. Maintains quality assurance on designated protocols. Collects data as required and assists in interpreting and evaluating results as required.

    3. Triages adverse events and communicates with the research physician regarding the occurrence of adverse events. Collects information regarding indicated medical follow-up with the subject and collateral informants as needed.

    4. Provides educational information to patients and their families. Serves as a resource and support person for patients and families by being a consistent person they can contact within the clinical research program. Provides information to the patient and family related to the healthcare of the patient such as health maintenance, prevention, and anticipatory guidance relevant to study-related diseases.

    5. Ensures uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner. Assists in preparing appropriate IRB (Institutional Review Board) forms, informed consents, correspondence with sponsor, etc., in an accurate and timely manner. May participate in the annual IRB approval and update process.

    6. Serves as a liaison to other departments and programmatic areas, as well as community agencies.

    7. Ensures that primary referring physicians receive timely progress notes on the patient’s diagnosis and treatment.

    8. May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.

    9. Department level responsibility. Some positions may have frequent interaction with patients, families, visitors, physicians, and related clinical departments.

    MINIMUM QUALIFICATIONS

    Must possess knowledge of clinical research methodologies as normally obtained by the completion of a bachelors' degree in a healthcare field.

    Experience typically gained through two to four years clinical research experience. Familiarity with medical and clinical terminology. Must have excellent organizational and task management skills. Ability to maintain confidentiality of patient and study information. Ability to maintain knowledge of Federal and State regulations governing practice as well as Institute policies and procedures related to medical and nursing practice. Excellent human relations, organizational and communication skills are required.

    PREFERRED QUALIFICATIONS

    Possession of Clinical Research Coordinator Certification (CRCC).

    Additional related education and/or experience preferred.

    **EEO Statement:**

    EEO/Female/Minority/Disability/Veterans (https://www.bannerhealth.com/careers/eeo)

    Our organization supports a drug-free work environment.

    **Privacy Policy:**

    Privacy Policy (https://www.bannerhealth.com/about/legal-notices/privacy)

    EOE/Female/Minority/Disability/Veterans

    Banner Health supports a drug-free work environment.

    Banner Health complies with applicable federal and state laws and does not discriminate based on race, color, national origin, religion, sex, sexual orientation, gender identity or expression, age, or disability


    Field of Interest

    Health Sciences

    Employment Type

    Full Time

  • Research Coordinator
    Northern Arizona University    Flagstaff, AZ 86011
     Posted 2 days    

    Research Coordinator

    Location: Ctr for Health Equity Research

    Regular/Temporary: Regular

    Job ID: 608178

    Full/Part Time: Full-Time

    Workplace Culture

    NAU aims to be the nation's preeminent engine of opportunity, vehicle of economic mobility, and driver of social impact by delivering equitable postsecondary value in Arizona and beyond.

    https://nau.edu/president/strategic-plan/

    Special Information

    • This position is subject to the availability of funding. The incumbent is not eligible for Service Professional non-renewal notice, or Classified Staff layoff or recall status.
    • This position is a hybrid position which allows the incumbent to complete their work at both an NAU site, campus, or facility and at a non-centralized site with or without accommodation.

    Job Description

    Center for Health Equity Research (CHER) is recruiting one (1) Research Coordinator to support the "Promoting Recreation Time among Individuals Incarcerated in Jail” project in the Southwest Health Equity Research Collaborative (SHERC), through data collection and analysis, conducting qualitative research including focus groups and reviews, Rapid Assessment of data (RARE methods), and analysis for interviews and focus groups.

    For more information on SHERC visit https://nau.edu/sherc/

    Job Duties and Responsibilities

    Data Collection and Analysis - 75%

    • Conduct interviews and focus groups among individuals incarcerated in Yavapai County jail.
    • Conduct Rapid Assessment (RARE methods) of interview and focus group data.
    • Plans, implements, and maintains data collection and analysis systems; may coordinate and support the collection and analysis of data.
    • Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, primarily for internal audiences.

    Program Coordination and Support - 10%

    • Scheduling meetings using virtual meeting platforms such as Zoom
    • Organizing and scheduling research tasks
    • Coordinates the day-to-day initiation and operation of research and data collection activities
    • Establishes and coordinates logistical arrangements for research subjects and outreach activities, as appropriate to the study

    Report and Manuscript - 10%

    • Organizing and supporting manuscript and report writing for the research team
    • Writing sections of manuscripts or reports as assigned

    Other - 5%

    • Other duties as assigned

    Minimum Qualifications

    • Bachelor's degree in public health, sociology, social work, anthropology, criminology, or related discipline.
    • 2-4 years of relevant research support experience.
    • Any combination of relevant education and experience may be substituted for the educational requirement on a year-for-year basis.

    Preferred Qualifications

    • Master of Public Health (MPH) preferred
    • Experience working with a protected population, such as incarcerated individuals, in a research setting

    Knowledge, Skills, & Abilities

    Knowledge

    • Demonstrated knowledge of Qualtrics, NVivo, and SAS for data analysis.
    • Experience conducting literature reviews.
    • Experience developing clinical protocols in research.
    • Proficiency using Microsoft Office, including Teams, Excel, Word, and PowerPoint

    Skills

    • Coding and analyzing qualitative data.
    • Proficiency with virtual meeting platforms and working with remote teams.
    • Strong organizational, planning, and time management skills
    • Project management experience
    • Strong written and verbal communication skills.

    Abilities

    • Ability to communicate effectively with both technical and non-technical audiences.
    • Promote a diverse and inclusive work environment.
    • Self-motivated and goal-oriented.

    Background Information

    Northern Arizona University requires satisfactory results for the following: a criminal background investigation, an employment history verification and a degree verification (in some cases) prior to employment. You may also be required to complete a fingerprint background check. Additionally, as an employer in the state of Arizona, NAU is required to participate in the federal E-Verify program that assists employers with verifying new employees' right to work in the United States. Finally, each year Northern Arizona University releases an https://in.nau.edu/police-department/annual-security-and-fire-safety-reports/. The report is a result of a federal law known as the Clery Act. The report includes Clery reportable crime statistics for the three most recent completed calendar years and discloses procedures, practices and programs NAU uses to keep students and employees safe including how to report crimes or other emergencies occurring on campus. In addition, the https://in.nau.edu/police-department/annual-security-and-fire-safety-reports/ is combined with the Annual Security Report for the NAU Flagstaff Mountain Campus as this campus has on-campus student housing. This report discloses fire safety policies and procedures related to on-campus student housing and statistics for fires that occurred in those facilities. If you would like a free paper copy of the report, please contact the NAUPD Records Department at (928) 523-8884 or by visiting the department at 525 E. Pine Knoll Drive in Flagstaff.

    Salary

    Anticipated salary range is $51,085 - $63,856. Annual salary commensurate with candidate's qualifications and related experience.

    FLSA Status

    This position is exempt from the overtime provisions of the Fair Labor Standards Act (FLSA) and therefore will not earn overtime or compensatory time for additional time worked.

    Benefits

    This is a Classified Staff (CLS) position. NAU offers an excellent benefit package including generous health, dental and vision insurance; participation in the Arizona State Retirement System; paid vacation and 10 holidays per year; and tuition reduction for employees and qualified dependents. More information on benefits at NAU is available on the https://in.nau.edu/Human-Resources/Benefits/. Classified Staff employees are in a probationary status for their first six months at NAU. NAU is a tobacco and smoke-free campus. Employees offered a position will be eligible for state health plans (including NAU's BCBS Plan). New employees arehttps://in.nau.edu/human-resources/benefits/ on the first day of the pay period following their enrollment, after their employment date. Employees will have 31 days from their start date to enroll in benefits. Additionally, new employees will begin participating in the Arizona State Retirement System, and the long-term disability coverage that accompanies it, on the first of the pay period following 6 months after the new employee's start date.

    Learning and Development

    Your career at Northern Arizona University includes the opportunity for professional development. https://in.nau.edu/human-resources/orientation/ includes courses to be completed within the first 30 days.

    Immigration Suppt/Sponsorship

    NAU will not provide any U.S. immigration support or sponsorship for this position.

    Application Deadline

    December 16, 2024 at 11:59 p.m.

    How to Apply

    To apply for this position, please click on the "Apply" button on this page. You must submit your application by clicking on the "Submit" button by midnight of the application deadline. If you need assistance completing your application there are instructions available on the https://in.nau.edu/human-resources/or in person in the Human Resources Department located in Building 91 on the NAU Campus - on the corner of Beaver and DuPont Streets.

    If you are an individual with a disability and need reasonable accommodation to participate in the hiring process, please contact the Disability Resources Office at 928-523-8773, http://[email protected], or PO Box 5633, Flagstaff AZ 86011.

    Equal Employment Opportunity

    Northern Arizona University is a committed Equal Opportunity/Affirmative Action Institution. Women, minorities, veterans and individuals with disabilities are encouraged to apply. NAU is responsive to the needs of dual career couples.

    https://in.nau.edu/Human-Resources/Posters-Required-by-Law/

    NAU is an Employer of National Service. AmeriCorps, Peace Corps, and other National Service alumni are encouraged to apply.

    To apply, visit https://apptrkr.com/5857909

    Copyright ©2024 Jobelephant.com Inc. All rights reserved.

    https://www.jobelephant.com/

    jeid-b75bfd14cc1ee3408d81780ac383f5f6


    Field of Interest

    Education

    Employment Type

    Full Time

  • Clinical Research Director (CRD) - General Medicine (REMOTE)
    Merck    Phoenix, AZ 85067
     Posted 6 days    

    **Job Description**

    The Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for GCTO country operations.

    Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is accountable for trial quality and audit responses and completion of CAPAs. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases in scope of GCTO within the country/cluster.

    The position has multiple touch points across the company which will be dependent on country/cluster and the study type and stage.

    **CRD is the primary country/ cluster level contact for GCTO and has the following key responsibilities:**

    + Supports the regional GCTO leadership team, leading strategic development of their country / cluster to deliver clinical trials as per global clinical research pipeline requirement.

    + Strategic country / cluster representative for initiatives at all levels of the organization.

    + Build and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed GCTO, GCD, and ourResearch & Development Division objectives.

    + Leads strategic development and management of institutional & investigator relationships in conjunction with our Research & Development Division / GCD Therapy Areas, and when appropriate Human Health.

    + Working with regional and global colleagues develops and executes the GCTO strategy for the country/cluster - such as Industry associations.

    **Leadership and Management of the GCTO country / cluster Organization:**

    + Recruits and hires talent.

    + Proactively manages and develops talent.

    + Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing staff and/or external recruitment.

    + Creates an empowering, compliant, collaborative, and innovation-focused work environment.

    + Builds a culture of quality and compliance through training, oversight, and collaboration.

    + Oversight to ensure appropriate scientific and operational training for staff members.

    **Clinical Operation Management:**

    + Ensures a single point of contact for managing clinical trial execution in all its aspects across all studies & phases in scope of GCTO within the country/cluster.

    **Leadership and oversight of the following:**

    + Our Research & Development Division / GCD / GCTO goals, initiatives and expectations.

    + Development and delivery of company standards in given geography.

    + Activities of all cluster/country level GCTO team & all programs and studies.

    + Approved administrative budget to support GCTO team (e.g., salaries & travel).

    + Country level operational study budgets.

    + Regulatory Inspections and internal audits; responding to inquiries by health authorities, ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory, Pharmacovigilance (PV) and Medical Affairs.

    + Responsible and supports development of audit responses and completion of CAPAs.

    **Collaborates and supports:**

    + Functional Service Provider (FSP) Senior, Regional and local Leadership to ensure adequate and appropriate resourcing for company internal clinical trial portfolio.

    + Clinical Research Organization (CRO) Senior, Regional and local Leadership to ensure the successful conduct of outsourced clinical trials.

    **Engagement With Key External Stakeholders**

    + Supporting Management and the clinical operations of studies managed by GCTO.

    + Support the development and management of Investigator and operational relationships in conjunction with all ourResearch & Development Division Therapy Areas, and when appropriate Human Health colleagues.

    + Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with Key Opinion Leaders (KOLs), etc.).

    **Quality / Compliance Adherence / Standard:**

    + Ensure that compliance, quality and timeline objectives are met for all trials executed in the country.

    + Sets clear performance standards and holds self and organization accountable for achieving results. Embraces GCTO metrics and performance standards (KPI’s).

    + Work collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs) and Regional Operations Teams, to deliver objectives.

    + Take responsibility for any clinical audits, working closely with the Quality Assurance (QA) group and the Good Clinical Practice Quality and Compliance Council (GCP QCC).

    **Extent of Travel** : up to 30%

    **CORE Competency Expectations:**

    + Significant Management experience in a Clinical Trials setting with the ability to service and collaborate with different stakeholders within GCTO and our Research & Development Division in a matrix organization.

    + Management expertise should cover management of budget, travel, resources, headcount, processes (and controls), productivity, quality and project delivery.

    + A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.

    + Strong Communication skills requiring proficiency in written and spoken English and preferably local language. The incumbent must be competent and effective in written and verbal communication.

    + Strategic thinking.

    **Behavioral Competency Expectations:**

    + High emotional intelligence.

    + Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, Leadership skills that enable and drive alignment with the goals, purpose and mission of our Company's Research Labs, Global Clinical Development (GCD) and GCTO

    + Positive proven success in people management.

    **Educational Requirements:**

    **Required** :

    + Bachelor’s degree in science or equivalent healthcare experience

    **Preferred** :

    + Advanced degree, (e.g., MD, PhD, Pharm D, MS, MBA)

    + Small-sized country / low to mid-complexity geography*

    + 5 years or more Experience in Clinical Trials**

    + 3 years of more people management experience

    ***Criteria for complexity includes:**

    + Country/affiliate size

    + Team size

    + Product portfolio

    + Pipeline and clinical trials

    + Scientific research environment, number of local data generations, Our Company Investigator Studies Programs

    + Access and healthcare policy environment

    ** Experience in Clinical Trial Operations gained from working at hospitals and/or research institutions, recognized clinical trial suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.

    ResearchandDevelopmentGCTO

    Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

    Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

    **US and Puerto Rico Residents Only:**

    Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

    We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

    EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

    EEOC GINA Supplement​

    Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

    We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

    Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

    **U.S. Hybrid Work Model**

    Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

    The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

    Expected US salary range:

    $164,800.00 - $259,400.00

    Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

    **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

    **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

    **Search Firm Representatives Please Read Carefully**

    Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    **Employee Status:**

    Regular

    **Relocation:**

    No relocation

    **VISA Sponsorship:**

    No

    **Travel Requirements:**

    25%

    **Flexible Work Arrangements:**

    Remote

    **Shift:**

    Not Indicated

    **Valid Driving License:**

    No

    **Hazardous Material(s):**

    N/A

    **Job Posting End Date:**

    12/21/2024

    ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**

    **Requisition ID:** R326034


    Employment Type

    Full Time

  • Clinical Research Coordinator II
    HonorHealth     SCOTTSDALE, AZ 85258
     Posted 7 days    

    Overview Looking to be part of something more meaningful? At HonorHealth, you’ll be part of a team, creating a multi-dimensional care experience for our patients. You’ll have opportunities to make a difference. From our Ambassador Movement to our robust training and development programs, you can select where and how you want to make an impact. HonorHealth offers a diverse benefits portfolio for our full-time and part-time team members designed to help you and your family live your best lives. Visit honorhealth.com/benefits to learn more. Join us. Let’s go beyond expectations and transform healthcare together. HonorHealth is one of Arizona’s largest nonprofit healthcare systems, serving a population of five million people in the greater Phoenix metropolitan area. The comprehensive network encompasses nine acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more. With more than 16,000 team members, 3,700 affiliated providers and over 1,100 volunteers dedicated to providing high quality care, HonorHealth strives to go beyond the expectations of a traditional healthcare system to improve the health and well-being of communities across Arizona. Learn more at HonorHealth.com. Responsibilities Job Summary The Coordinator-Clinical Research II is the primary contact with the study sponsor and is responsible for the day-to-day management of project activities and resources and overall clinical data and protocol management for the conduct of clinical trials at HonorHealth. Responsible for clinical and/or data management of complex protocols. May be involved in many of the following activities: recruitment, screening, obtaining informed consent, reviewing source documents, data collection, data entry, query resolution, triggering financial payments, study startup/close out. Serves as a liaison with sponsor. Collects, verifies, organizes, completes and records clinical information and data in case report forms. May be involved in many of the data related activities: CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation, resolve queries and safety coding. Assists with subject follow-up for clinical protocols and documents/report clinical study progress as required. Obtains all reports and submits data forms and pathology and radiology materials according to protocol requirements. Conducts protocol administration quality control monitoring, enforcement and database maintenance. May participate in site initiation, interim monitoring, and study close out visits with sponsor and FDA initiated audits as needed. May be required to handle and label samples and ship samples according to protocol requirements. Facilitates ongoing set up and closing of clinical protocols. Assists with creation and implementation of tools to continuously monitor team performance. Communicates departments measurable improvements and positive trends to management. Assists with team guideline adherence to timely preparation of study documents, data entry, and data locks. Precepting and training on new systems and programs applicable to the coordination role. Assists with weekly tracking and reporting of team’s workload and progress. Assists in development and implementation of departmental operating procedures. Represents coordination team in a variety of meetings. May assist in the creation of business development proposals by supplying coordination related information and costs. Assists leadership with conduct of monthly quality check of recorded and submitted data. This includes the verification of proper documentation of the data, deviations, and compliance with deadlines. Assists with the identification and documentation of regulatory and protocol deviation findings, including IRB reporting. Provides assistance as needed to peer to ensure that study deadlines are met. Identifies data management project issues and alerts leadership and makes recommendations. Maintains communication with supervisor regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices. Participates in precepting and training of staff on data management procedures, and systems. Performs other related duties as assigned. Qualifications Education Bachelor's Degree in Health Science or 4 years of health science-related experience Required Experience 2 years of progressively responsible clinical/clinical research or data management experience Required Licenses and Certifications Basic Life Support (BLS) Required


    Field of Interest

    Health Sciences

    Employment Type

    Full Time

  • Clinical Research Coordinator Orthopedics
    Banner Health    Phoenix, AZ 85067
     Posted 7 days    

    **Primary City/State:**

    Phoenix, Arizona

    **Department Name:**

    Sports Medicine Surgery-Clin

    **Work Shift:**

    Day

    **Job Category:**

    Research

    Good health care is key to a good life. At Banner Health, we understand that, and that’s why we work hard every day to make a difference in people’s lives. We’ve united under a common goal: Make health care easier, so life can be better. It’s a lofty goal, but it’s one we’re committed to seeing through. Do you like the idea of making a positive change in people’s lives – and your own? If so, this could be the perfect opportunity for you. Apply now.

    TOCA at Banner Health is at the forefront of the Integrated Service Model. We are committed to continually improving our delivery of orthopedic care to meet the needs of our patients. Our Board-certified & Fellow-trained Physicians specialize in: Fracture Care, Joint Replacement, Sports Medicine, Physical Therapy, Hand Therapy, Digital X-Ray, MRI, Bracing & Orthotics, and more!! By utilizing the most innovative procedures and true state-of-the-art technology, our staff of general orthopedists and sub-specialists have earned a reputation for providing consistent specialized orthopedic care. TOCA’s reputation is built on treating each patient’s specific needs, which is one of reasons why we are the choice of primary care physicians and performance athletes throughout the Valley (Tempe, Scottsdale, Phoenix, and Glendale). We are also honored to be the official team physicians and orthopedic surgeons for Arizona State University.

    TOCA at Banner strives to push boundaries, challenge the norm, and come up with ways to make health care easy for our patients and for our staff. If you are looking to be challenged, work with a large team that is focused on getting the absolute best results for patients, then TOCA at Banner Phoenix is just the place to start or continue your journey in healthcare. As a **Clinical Research Coordinator** , you will be able to use your experiences with assisting a provider with continuing to build his research portfolio and research his projects. In addition, this role will assist the provider with the required study documentation and meeting sponsor driven timelines. A career with TOCA at Banner is great if you are just starting out; or have many years’ experience. Everyone at Banner contributes to our patients lives! Our team is like a family and we help one another, empower one another to make decisions, and encourage natural talents so each member can grow.

    **Location:** TOCA Phoenix - 2222 E Highland Ave, Ste 300Phoenix, AZ 85016

    **Schedule:** Monday -Friday 8:00am-4:30pm

    POSITION SUMMARY

    This position is responsible for coordinating and/or implementing assigned protocols. This position includes collecting and recording medical data and history, assisting in patient assessments, and maintaining study files.

    CORE FUNCTIONS

    1. Provides study information and obtains relevant information to and from patients engaged in clinical studies, which includes: assisting in the recruitment and screening of volunteers; registering patients; providing information on clinical trials and protocols to interested participants in a timely and helpful manner; obtaining relevant medical history on candidates by phone and in person; collecting previous relevant medical records data on patient; explaining procedures and consent forms; compiling all information prior to the initial visit; responding to inquiries from study participants or collateral informants in a timely and helpful manner; updating databases with patient information; and/or, performing other related activities.

    2. Performs tasks required by protocol, which may include obtaining patient medical history, systems review, phlebotomy, EKG, and cognitive assessment on patients. Collects vital signs. Maintains quality assurance on designated protocols. Collects data as required and assists in interpreting and evaluating results as required.

    3. Triages adverse events and communicates with the research physician regarding the occurrence of adverse events. Collects information regarding indicated medical follow-up with the subject and collateral informants as needed.

    4. Provides educational information to patients and their families. Serves as a resource and support person for patients and families by being a consistent person they can contact within the clinical research program. Provides information to the patient and family related to the healthcare of the patient such as health maintenance, prevention, and anticipatory guidance relevant to study-related diseases.

    5. Ensures uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner. Assists in preparing appropriate IRB (Institutional Review Board) forms, informed consents, correspondence with sponsor, etc., in an accurate and timely manner. May participate in the annual IRB approval and update process.

    6. Serves as a liaison to other departments and programmatic areas, as well as community agencies.

    7. Ensures that primary referring physicians receive timely progress notes on the patient’s diagnosis and treatment.

    8. May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.

    9. Department level responsibility. Some positions may have frequent interaction with patients, families, visitors, physicians, and related clinical departments.

    MINIMUM QUALIFICATIONS

    Must possess knowledge of clinical research methodologies as normally obtained by the completion of a bachelors' degree in a healthcare field.

    Experience typically gained through two to four years clinical research experience. Familiarity with medical and clinical terminology. Must have excellent organizational and task management skills. Ability to maintain confidentiality of patient and study information. Ability to maintain knowledge of Federal and State regulations governing practice as well as Institute policies and procedures related to medical and nursing practice. Excellent human relations, organizational and communication skills are required.

    PREFERRED QUALIFICATIONS

    Possession of Clinical Research Coordinator Certification (CRCC).

    Additional related education and/or experience preferred.

    **EEO Statement:**

    EEO/Female/Minority/Disability/Veterans (https://www.bannerhealth.com/careers/eeo)

    Our organization supports a drug-free work environment.

    **Privacy Policy:**

    Privacy Policy (https://www.bannerhealth.com/about/legal-notices/privacy)

    EOE/Female/Minority/Disability/Veterans

    Banner Health supports a drug-free work environment.

    Banner Health complies with applicable federal and state laws and does not discriminate based on race, color, national origin, religion, sex, sexual orientation, gender identity or expression, age, or disability


    Field of Interest

    Health Sciences

    Employment Type

    Full Time

  • Clinical Research Coordinator
    HonorHealth     SCOTTSDALE, AZ 85258
     Posted 9 days    

    Overview Looking to be part of something more meaningful? At HonorHealth, you’ll be part of a team, creating a multi-dimensional care experience for our patients. You’ll have opportunities to make a difference. From our Ambassador Movement to our robust training and development programs, you can select where and how you want to make an impact. HonorHealth offers a diverse benefits portfolio for our full-time and part-time team members designed to help you and your family live your best lives. Visit honorhealth.com/benefits to learn more. Join us. Let’s go beyond expectations and transform healthcare together. HonorHealth is one of Arizona’s largest nonprofit healthcare systems, serving a population of five million people in the greater Phoenix metropolitan area. The comprehensive network encompasses six acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more. With nearly 15,000 team members, 3,700 affiliated providers and close to 2,000 volunteers dedicated to providing high quality care, HonorHealth strives to go beyond the expectations of a traditional healthcare system to improve the health and well-being of communities across Arizona. Learn more at HonorHealth.com. Responsibilities Job Summary Position provides clinical data support for the conduct of clinical research at HonorHealth Research Institute. The position works closely with all Research Staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization, and Good Clinical Practices. Assists in the coordination and management of inpatient and outpatient studies, according to protocol and sponsor amendments. Provides data and or clinical management project support for multidisciplinary clinical research, including patient screening for study eligibility, obtaining informed consent and subject registration. Collects, verifies, organizes and records clinical information and data in case report forms. Abstracts data from necessary sources to complete all forms to the required quality. Performs the following data related activities: CRF tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding. Assists with subject follow-up for clinical protocols. Works with the research team to track study progress and may be involved in the development of periodic status reports. May assist with the preparation of annual reports and statistical information on clinical research as required by the Institute, System. IRB, or investigators. Assists with the creation and implementation of tools to continuously improve team’s performance. Communicates department’s measurable improvements and positive trends to management. Assists with team guideline adherence to timely preparation of study documents, data entry and data locks. Participates in tracking and reporting of workload and progress. Assists in development and implementation of departmental operation procedures. Represents coordination team in study feasibility, implementation, and close out activities. May assist in creation of business development proposals by supplying data and or patient management related information. Maintains communication flow through the term of the study. Assists with obtaining all reports and submits data forms and materials according to protocol requirements. Identifies the achievement of key milestones such as draft or final database. Provides assistance as needed to peer to ensure that study deadlines are met. Mentoring and training on new systems and programs applicable to the coordinator role. Provides support to Research Staff in execution of pharmaceutical or investigator initiated clinical protocols within scope of role. Handles and labels samples and ships samples according to protocol requirements. Maintains communication with the Research Staff regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practices. Provides input and assistance to the Research Staff in maintaining the Regulatory Binders for all ongoing research studies in accordance with FDA regulations and sponsor requirements. Maintains working relationships with external customers (e.g. professional research organizations and physicians). Assists leadership with conduct of monthly quality check of data recorded and submitted. This may include verification of proper documents of clinical data, deviations within a specific time period. Assists with identification and documentation of regulatory and protocol deviation findings. Analyzes findings and communicated possible solutions to leadership. May be involved in verification of proper reporting of events, including IRB reporting. Performs other related duties as assigned. Qualifications Education High School Diploma or GED Required Experience 2 years experience working with data, or a technician working in a healthcare environment, or currently enrolled in/completed a research educational program or 1 year of experience as a clinical research admin support specialist at HonorHealth Research Institute Required Licenses and Certifications Basic Life Support (BLS) Required


    Field of Interest

    Health Sciences

    Employment Type

    Full Time

  • Clinical Research Coordinator
    Dignity Health    Phoenix, AZ 85067
     Posted 9 days    

    **Overview**

    Hello humankindness (https://hellohumankindness.org/)

    Located conveniently in the heart of Phoenix, Arizona, (http://phoenix.gov/visitors/index.html) St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved.

    We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute (https://www.barrowneuro.org/) , Norton Thoracic Institute (https://www.dignityhealth.org/arizona/norton-thoracic-institute) , Cancer Center at St. Joseph's (https://www.dignityhealth.org/arizona/locations/stjosephs/services/university-of-arizona-cancer-center) , Ivy Brain Tumor Center (https://www.ivybraintumorcenter.org/) , and St. Joseph's Level I Trauma Center (https://www.supportstjosephs.org/traumacenter) (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph’s is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital’s patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph’s.

    _U.S News & World Report_ routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital.

    St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies (http://www.bestcompaniesaz.com/) .

    Look for us on Facebook (http://www.facebook.com/DignityHealthStJosephsHospitalMedicalCenter) and follow us on Twitter (https://twitter.com/DignityHealthAZ) .

    _For the health of our community ... we are proud_ _to be_ _a tobacco-free campus_

    **Responsibilities**

    Coordinate and participate in clinical research studies. Responsibilities include collection, compilation, documentation and analysis of clinical research data.

    Responsibilities Include:

    + Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.

    + Coordinate patient care within the multi-disciplinary team.

    + Act as a specialists/resource person; provide support, recommendations and advice to all personnel involved with the study.

    + Able to review minimally necessary data extracts for the purpose of identifying potential research candidates from our patient population. If a potential candidate is identified, they will work with the Primary Physician to begin the consenting process.

    + Participate in various study procedures that may include obtaining blood, tissue or other specimens for laboratory analysis; EKG, echocardiogram, exercise treadmill testing, monitoring devices; and/or cardiac catheterization andinterventional procedures.

    + Ensure compliance with protocol guidelines and requirements of the institutional review board (IRB) and FDA regulations

    + Responsible for preparation of IRB documents, including submission of clinical trial protocols, amendments and study modifications; reporting of serious adverse events; annual reports; and/or study closure.

    + Ensuring all personnel associated with the implementation of clinical trials are adequately educated to the disease process, protocol requirements, special procedures, therapeutic treatment and technological devices through group or individual education meetings.

    + Ensure patient/subject participant safety by actively exercising the patient advocacy role and implementing the ongoing process of informed consent to ensure patient's confidentiality and autonomy is maintained.

    **Qualifications**

    Three years clinical research experience required

    Education

    Bachelor's Degree in a related field Bachelor's Degree in a related field

    Special Skills

    Competent in computer skills PowerPoint Excel, e-mail and Internet. Strong organizational and planning skills. Ability to consistently meet deadlines and manage workload.

    **Pay Range**

    $30.55 - $44.30 /hour

    We are an equal opportunity/affirmative action employer.


    Field of Interest

    Health Sciences

    Employment Type

    Full Time

  • Clinical Research Coordinator
    Mayo Clinic    Phoenix, AZ 85067
     Posted 14 days    

    **Why Mayo Clinic**

    Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans (https://jobs.mayoclinic.org/benefits/) – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic. You’ll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.

    **Responsibilities**

    Receives direction from principal investigator, supervisor, or other staff involved in research protocol(s). Gives direction to and works cooperatively with other research staff. Collaborates with various departments within the institution. Works cooperatively with other investigators and personnel at all levels. Interacts with research participants, other research centers, and sponsoring companies to resolve problems and ensure efficient completion of research studies.

    Position Overview: (Major Functions and Non-Essential Functions):

    Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. Collaborates with research team to assess feasibility and management of research protocols. Ensures implementation of research protocols after IRB approval and provides information as appropriate for progress reports. Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Manages, monitors, and reports research data to maintain quality and compliance. Provides education/training for others within the department. Performs administrative and regulatory duties related to the study as appropriate. Some travel may be required. ADDENDUM (if applicable) Protocol Development and Maintenance Activities Responsibilities may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements. Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. Participates in other protocol development activities and executes other assignments as warranted and assigned.

    **Additional Information:**

    This position is onsite and may be eligible for telework 1-2 days per week after a patient and study assessment has been completed and deemed acceptable. While working remotely, staff are expected to be onsite for essential study tasks. Staff must also successfully complete a 6-month training assessment, demonstrate ability to work independently, be reliable, and exhibit efficiency and accuracy of completing tasks.

    **Qualifications**

    Minimum Education and/or Experience Required: (Education Requirements and Experience):

    HS Diploma with at least 5 years of clinical research coordination/related experience OR Associate's degree/college Diploma/Certificate Program with at least 3 years of experience, Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience. Experience should be in the clinical setting or related experience.

    Additional Experience and/or Qualifications: (Has Achieved Competency in the Following Areas, Job Knowledge and Additional Considerations):

    Graduate or diploma from a study coordinator training program is preferred. One year of clinical research experience is preferred. Medical terminology course is preferred.

    Licensure/Certification Required:

    N/A

    **Exemption Status**

    Nonexempt

    **Compensation Detail**

    $30.12 - $45.19 / hr

    **Benefits Eligible**

    Yes

    **Schedule**

    Full Time

    **Hours/Pay Period**

    80

    **Schedule Details**

    M-F, 8-5

    **Weekend Schedule**

    NA

    **International Assignment**

    No

    **Site Description**

    Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. (https://jobs.mayoclinic.org/alllocations)

    **Affirmative Action and Equal Opportunity Employer**

    As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.

    **Recruiter**

    Matt Burdick

    **Equal opportunity**

    As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.


    Employment Type

    Full Time

  • Clinical Research Administrative Support
    HonorHealth     SCOTTSDALE, AZ 85258
     Posted 14 days    

    Overview Looking to be part of something more meaningful? At HonorHealth, you’ll be part of a team, creating a multi-dimensional care experience for our patients. You’ll have opportunities to make a difference. From our Ambassador Movement to our robust training and development programs, you can select where and how you want to make an impact. HonorHealth offers a diverse benefits portfolio for our full-time and part-time team members designed to help you and your family live your best lives. Visit honorhealth.com/benefits to learn more. Join us. Let’s go beyond expectations and transform healthcare together. HonorHealth is one of Arizona’s largest nonprofit healthcare systems, serving a population of five million people in the greater Phoenix metropolitan area. The comprehensive network encompasses six acute-care hospitals, an extensive medical group with primary, specialty and urgent care services, a cancer care network, outpatient surgery centers, clinical research, medical education, a foundation, an accountable care organization, community services and more. With nearly 15,000 team members, 3,700 affiliated providers and close to 2,000 volunteers dedicated to providing high quality care, HonorHealth strives to go beyond the expectations of a traditional healthcare system to improve the health and well-being of communities across Arizona. Learn more at HonorHealth.com. Responsibilities Job Summary Position provides support for clinical trials and activities in the maintenance of clinical research at HonorHealth Research Institute. The position works closely with Research Coordination, Regulatory, and trial administration Staff to manage administrative activities, data management, and archiving activities as assigned. They will help transition paper records to online electronic binders in accordance with FDA Regulations, International Council of Harmonization, and Good Clinical Practices and manage the collection and distribution of performance metrics Provides data management project support for clinical research trials in an activation stage and active stage, including patient pre-screening for study eligibility, support for data submission and records clinical information in case report forms. Assists in the coordination and management of the CTMS to ensure trial activities are documented correctly and the finance team can bill promptly. Assists with subject follow-up for assigned clinical protocols. Supports record archiving of documentation no longer needed for trial management, scans paper-based binders and converts to electronic binders as assigned. Support the collection of data points for HRI2 processes and distribute to program management and HRI2 leadership for review and performance analysis Maintains clear and regular communication with the Research Staff regarding project updates and assignments made. Provides input and assistance to the Research Staff in maintaining the Regulatory Binders for all ongoing research studies in accordance with FDA regulations and sponsor requirements. . Maintains working relationships with external customers (e.g. professional research organizations and physicians) to facilitate the submission of clinical investigational material to the appropriate regulating body. Performs other related duties as assigned. Qualifications Education High School Diploma or GED Required


    Field of Interest

    Health Sciences

    Employment Type

    Full Time

  • Clinical Trial Coordinator - Monitoring (CTC-M) (REMOTE)
    Merck    Phoenix, AZ 85067
     Posted 16 days    

    Job Description

    Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing, and archiving clinical documents. The CTC-M supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

    The role is critical to meet planned Site Ready dates, including assisting with the preparation of submission packages to IRB/ERC and Health Authorities. The role will collaborate at local level closely with COM, CRM and CRA. And the person collaborates with finance/budgeting representatives to manage CTRAs and payments.

    Responsibilities include, but are not limited to:

    + Trial and site administration:

    + Provide expert assistance with data tracking and reporting tasks to various teams within the Site Management & Monitoring organization

    + Ensure collation and distribution of study tools and documents

    + Update clinical trial databases (CTMS) and trackers

    + Clinical supply & non-clinical supply management, in collaboration with other country roles

    + Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)

    + Document management:

    + Prepare documents and correspondence

    + Collate, distribute/ship, and archive clinical documents, e.g. eTMF

    + Assist with eTMF reconciliation

    + Execute eTMF Quality Control Plan

    + Update manuals/documents (e.g., patient diaries, instructions)

    + Document proper destruction of clinical supplies.

    + Prepare Investigator trial file binders

    + Obtain translations of documents

    + Regulatory & Site Start-Up responsibilities:

    + Collaborate with other country roles to:

    + In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions

    + Obtain, track and update study insurance certificates

    + Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.

    + Publish study results for GCTO and RA where required per local legislation

    + Budgeting, Agreement and Payments:

    + Collaborate with finance/budgeting representatives for:

    + Develop, control, update and close-out country and site budgets (including Split site budget)

    + Develop, negotiate, approve and maintain contracts (e.g. CTRAs)

    + Track and report contract negotiations

    + Update and maintain contract templates (in cooperation with Legal Department)

    + Calculate and execute payments (to investigators, vendors, grants)

    + Ensure adherence to financial and compliance procedures

    + Monitor and track adherence and disclosures

    + Maintain tracking tools

    + Obtain and process FCPA documentation in a timely manner

    + Meeting Planning:

    + The tasks may include but are not limited to coordinating meetings and site visits, tracking, managing, and analyzing study data, and preparing reports.

    + Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)

    **Qualifications, Skills & Experience Skills:**

    + Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skillsGood understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

    + Hands on knowledge of Good Documentation Practices

    + Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications.

    + Strong MS Excel skills required.

    + ICH-GCP Knowledge appropriate to role

    + Excellent negotiation skills for CTCs in finance area

    + Effective time management, organizational and interpersonal skills, conflict management

    + Effective communication with external customers (e.g. sites and investigators)

    + High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment

    + Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

    + Demonstrates commitment to Customer focus, both internally and externally.

    + Able to work independently

    + Proactive attitude to solving problems / proposing solutions

    + Positive mindset, growth mindset

    **Qualification & Experience:**

    + Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree.

    ResearchandDevelopmentGCTO

    MSJR

    Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

    Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

    **Search Firm Representatives Please Read Carefully**

    Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    **Employee Status:**

    Regular

    **Relocation:**

    No relocation

    **VISA Sponsorship:**

    No

    **Travel Requirements:**

    10%

    **Flexible Work Arrangements:**

    Remote

    **Shift:**

    Not Indicated

    **Valid Driving License:**

    No

    **Hazardous Material(s):**

    N/A

    **Job Posting End Date:**

    11/30/2024

    ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**

    **Requisition ID:** R323669


    Employment Type

    Full Time


Related Careers & Companies

Health Sciences

Not sure where to begin?

Match Careers with Interests

Career Exploration

Browse by Field of Interest