Clinical Research Coordinators

Manager, Research Project for Caporaso Lab

Location: PMI

Regular/Temporary: Regular

Job ID: 608220

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/

Job Description

The Caporaso Lab is hiring a Manager, Research Project to provide leadership and management of daily operations for the support of research, education, and outreach activities in the Caporaso Lab. This individual will support broad research activities, including supporting the development of the Compost Microbiome Discovery Living Lab, overseeing day-to-day operations on grant-funded research projects, coordination of efforts for the Four Corners Science and Computing Club, assistance with other research support, and assistance with administrative aspects of research projects.

Job Duties and Responsibilities

Caporaso Lab Support and Coordination - 30%

• Work with Prof Caporaso to define Caporaso Lab objectives and develop detailed plans, timelines, and budgets.
• Align Caporaso Lab research program goals with funding strategies and mechanisms and identify opportunities for collaboration within and outside of NAU.
• Manage and coordinate projects under the Caporaso Lab research program, ensuring milestones are met. This will include grants, and bioinformatics education and service projects.
• Acts as the primary administrative point of contact for internal research staff and as an operational liaison for other research organizations, funding agencies, and regulating bodies for research project.
• Track program metrics to evaluate success and make data-driven adjustments.
• Provide regular reports to Professor Caporaso on program performance and outcomes.
• Lead the development, execution and administration of an annual microbiome data science workshop, either at NAU or online, to assist with fundraising for the lab while building visibility for the Caporaso Lab research program.

Compost Microbiome Research - 30%

• Lead efforts to develop funding for and establish the Compost Microbiome Discovery Living Lab (CMDLL), including assistance with the development of grant proposals and exploration of funding opportunities.
• Lead initial Human Excrement Composting microbiome projects, with the 1-2 year goal of developing student-led projects.
• Communicate program progress, risks, and outcomes while building relationships with stakeholders, including governments, nonprofits, businesses, and educational institutions, to promote sustainability and scientific computing initiatives.
• Engage in research, conferences, or professional development activities to remain updated in the field.
• Maintain current knowledge of subject matter and integrate relevant trends into coursework.

Community Outreach, Education, and Partnership - 20%

• Design and execute CMDLL educational programs, workshops, and events focused on sustainability topics such as renewable energy, waste reduction, water conservation, and climate change.
• Lead efforts to raise awareness about the CMDLL research mission and programs through social media, events, and public speaking.
• Advocate for sustainable practices within the community and beyond.
• Collaborate with schools, universities, and community organizations to integrate sustainability and scientific computing education into curricula and outreach activities.

Personnel Supervision and Leadership -10%

• Resolve personnel conflicts and work with individual project teams under the Caporaso Lab research program to develop solutions to project challenges.
• Oversee daily operations of CMDLL, including staffing, facilities, and resource management.
• Assist Prof Caporaso with supervision of day-to-day work of undergraduate and graduate students in the lab.
• Supervises, trains, and oversees lower-level staff.

Budget Oversight and Development - 5%

• Work with the PMI Admin team to monitor Caporaso Lab budget, and adjust Caporaso Lab research program goals accordingly.
• Provides oversight and administrative and fiscal support to investigators and research staff; assists with establishing budgets and financial reporting procedures, and monitors and controls expenditures.

Other duties as assigned - 5%

Minimum Qualifications

• Master's degree in Biology or microbiome related field, with respect to compost system microbiomes.
• 1-2 years of management or supervisory experience
• 2-4 years of relevant experience
• Any combination of relevant education and experience may be substituted for the educational requirement on a year-for-year basis.

Preferred Qualifications

• PhD degree in microbiome-related field, ideally with respect to compost system microbiomes.

Knowledge, Skills, & Abilities

Knowledge

• Advanced knowledge of principles and techniques of relevant research practices.
• Advanced knowledge of research methods, protocols, data collection, and analysis.
• Intermediate knowledge of relevant research discipline.
• Knowledge of proper safety and compliance practices related to the conduct of research.
• Knowledge of supervisory practices and principles.

Skills

• Organizational and project management skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Advanced technical understanding and proficiency related to conducting relevant research procedures.

Abilities

• Possesses strong leadership practices.
• Motivates and empowers staff and facilitates communication across individuals and teams.
• Monitors and coordinates complex research activities with multiple components.
• Balances competing priorities and makes decisions regarding resource allocation.
• Organizes data and information and supports analysis; may conduct independent analysis or review.
• Communicates effectively to both technical and and non-technical audiences, including external parties.
• Promotes a diverse, inclusive environment.

Background Information

This position has been identified as a safety/security sensitive position. Therefore, per AZ Revised Statute, Northern Arizona University requires satisfactory results for the following: a criminal background investigation, employment history investigation, degree verification (in some cases) and fingerprinting. If you are applying for a job that requires a CDL, you will be required to register with the Federal Motor Carrier Safety Administration Drug & Alcohol Clearinghouse and adhere to the clearinghouse requirements. 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

Salary Range is $$67,714 - $77,871. 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 Service Professional (SPF) position. NAU offers an excellent benefit package including generous health, dental and vision insurance; participation in the Arizona State Retirement System or the Optional Retirement Program; 22 days of 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/. NAU is a tobacco and smoke-free campus. Service Professionals are hired on a contract basis, renewable each 6 months according to https://public.powerdms.com/ABOR/documents/1499270. Employees offered a position will be eligible for state health plans (including NAU's BCBS Plan). New employees are https://in.nau.edu/human-resources/eligibility-enrollment/ 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. If a new employee chooses the ASRS retirement option, participation in the Arizona State Retirement System, and the long-term disability coverage that accompanies it, will begin on the first of the pay period following 6 months after the new employee's start date. New employees who choose to participate in the Optional Retirement Plan (ORP), which is an alternative to the ASRS plan for faculty and other appointed staff, will begin to participate on the first day of the pay period following election. Additionally, the long-term disability plan that accompanies the ORP will begin on the first day of the pay period following election.

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

February 3, 2025 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/5930883

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Title: Clinical Research Coordinator

Type: Permanent

Location: Tucson, AZ (100% onsite)

Start Date: ASAP

Due to our continued growth, we are hiring for a Clinical Research Coordinator. This position is on-site and located in Tucson, AZ.

Job Description

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

Essential Duties and Responsibilities:

+ Assisting trial Investigator in screening and review of potential study participants eligibility

+ Maintaining case report forms, charts and documentation

+ Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants

+ Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements

+ Collecting and entering data as necessary

+ Assist management with potential new hire selection and shadowing process

+ Assist with study start-up, maintenance, and close-out of studies as needed for those on the team

+ Ability to be flexible with study assignments

Qualifications

+ Clinical Research Coordinator with 1-2 years of experience

+ Phlebotomy experience is highly preferred

+ Previous experience as a medical assistant, LPN, or RN

+ Excellent verbal & written communication skills

+ Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking

+ Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines

+ Extensive clinical trial knowledge through education and/or experience

+ Successful completion of GCP Certification and Advanced CRC preferred

+ Detail-oriented

+ Familiarity with the Code of Federal Regulations as they pertain to human subject protection

+ Strong interpersonal skills

Benefits:

+ 401(k), 401(k) matching

+ Dental insurance

+ Disability insurance

+ Employee assistance program

+ Flexible spending account

+ Health insurance

+ Life insurance

+ Paid time off

+ Vision insurance

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

**Ready To Go Further?**

Saia is a different kind of logistics and transportation company. We do things the right way. You‘ll see it in our commitment to our people, customers, and community. You‘ll feel it in the support you get on day one – from leadership and from your team. A job with Saia is packed with opportunity – from learning new skills and advancing to competitive compensation and great benefits. It's all here and it’s exactly what _going further_ is all about.

**Position Summary**

Oversees the weighing and research program for designated terminals. Validates proper classification and accurate weight representation for shipments.

**Major Tasks and Responsibilities**

+ Oversees dockworker performance to ensure compliant use of weighing, dimensioning equipment, and dock procedures.

+ Collaborates with regional and terminal operations teams to address personnel issues related to weight and research process compliance.

+ Coordinates with maintenance and information technology teams to address forklift scale and dimensioning equipment issues.

+ Facilitates accurate invoicing through freight inspection, dimensioner data analysis, product research, and shipper classifications.

+ Documents weight and research changes for efficient dispute resolution and freight charge collections.

+ Aids the sales team with necessary National Motor Freight Classification information for customers.

**Preferred Qualifications**

+ Bachelor’s degree in transportation, business, or a related field.

+ 2+ years of weight and research or transportation experience.

+ Working knowledge of the National Motor Freight Classification, packaging, and regulations.

+ Proficiency in Microsoft Office.

+ Willingness to travel and work flexible hours.

**Benefits**

At Saia, your success is our success! That’s why we work hard to provide you with what you need to build an awesome career. We are committed to rewarding superior employee performance so that when you work hard, your achievements won’t go unnoticed.

**Make Your Move**

At Saia, our people are the reason we’ve been successful for over a century in the industry. Together, we’ve created a positive culture that’s driven by our core values – like dignity and respect, a customer-first approach, safety and more. With hundreds of terminals across the country and growing, we’re always looking for more collaborative and motivated individuals to join our team. So, if you’re ready to put your career on a solid path, let’s go further.

Saia is an Equal Opportunity Employer and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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 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

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 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

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 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

**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.

**Benefits Highlights**

+ Medical: Multiple plan options.

+ Dental: Delta Dental or reimbursement account for flexible coverage.

+ Vision: Affordable plan with national network.

+ Pre-Tax Savings: HSA and FSAs for eligible expenses.

+ Retirement: Competitive retirement package to secure your future.

**Responsibilities**

Receives direction from principal investigator, supervisor, or other staff involved in research protocol(s). Interacts 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):

Coordinates non-therapeutic (i.e. minimal risk, survey, chart review) clinical research protocols with direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. May assist in complex (i.e. interventional, therapeutic, greater than minimal risk) studies with direction but does not have overall responsibility for these studies. Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Recognizes adverse events, protocol deviations, and other unanticipated problems and reports appropriately. Collects, abstracts, and enters research data. Performs administrative and regulatory duties related to the study as assigned. 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. data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; Institutional Review Board (IRB) submission; and communication with study sites and/or federal agencies regarding study status changes. Participates in other protocol development activities and executes other assignments as warranted and assigned.

**Qualifications**

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

HS Diploma with at least 3 years of experience OR Associate's degree/college Diploma/Certificate Program with at least 1 year of experience, Associate’s in Clinical Research from an accredited academic institution without experience OR Bachelor's degree. 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**

$25.37 - $37.61 / hr

**Benefits Eligible**

Yes

**Schedule**

Full Time

**Hours/Pay Period**

80

**Schedule Details**

Monday - Friday (8:00 A.M. - 5:00 P.M)

**Weekend Schedule**

N/A

**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.

**Job Description**

This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our Company policies and procedures and

with quality standards internally and externally.

Under the oversight of the CRD / Director, Clinical Research, the individual is responsible to manage/oversee a team of CTCs.

As line manager the role is critical to continuously develop future talent by providing training, support and mentoring to the CTCs, as well as for interns delegated to the Clinical Operations team based on the Internship program, while properly managing situations of low or non-performance.

The role will work across the different country operations roles (e.g. CRM, CRA-Manager, Partners, TA-Head, CRD and Sr.COM) to ensure alignment and development of the country CTC capabilities. The person contributes to CTC capacity/resource planning activities to ensure efficient allocation of resources and work.

**Responsibilities include, but are not limited to:**

+ Has significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.

+ Ensure and oversee proper on‐boarding and off‐boarding of employees, compliance to initial and ongoing trainings.

+ Train and oversee the CORE competencies, ICH‐GCP knowledge, Clinical Research environment etc.

+ Assure adherence to GCP guidelines, processes and procedures related to direct reports’ activities and performance.

+ Ensure direct reports are compliant to the timelines and key business metrics.

+ Review and approve timesheets, GTT compliance, expense reports, time‐off requests and provide proper oversight of CTC's productivity/utilization.

+ Provide input for capacity planning, including reporting of current manpower and

+ forecasting of CTC capacity and needs, to provide efficient use of resources.

+ Work with CRDs, TA-Heads, CRMs, CRA-Manager, Sr. COM, CRAs, Partners and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.

+ Interacts with CRMs and sites as needed to resolve operational issues, to meet commitments in a timely manner and in coordination with the study CRM and CRA.

+ Interface with GCTO partners on clinical trial execution as assigned; including acts as lead liaison with CTC FSP partners in facilitating coordinated process and country delivery.

+ Escalates site performance issues to CRM and CRD/TA-Head.

+ People and Resource Management:

- Manages CTC – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.

- Supports and resolves escalation of issues from CTCs.

- Manages capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.

+ Ensures CTC compliance to corporate policies, procedures and quality standards.

**Extent of Travel** : Minimal travel required

**Skills** :

+ Demonstrates proactive leadership and must be able to in/directly influence vendors, external partners and country managers to deliver these commitments within specified timelines with minimal oversight from the line manager.

+ Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decision maker with a clear understanding of the pros and cons of each decision and takes ownership of decisions.

+ Ability to work independently and in a team environment.

+ Excellent people management, time management, project management and organizational skills

+ History of strong performance and leadership.

+ Skills and judgment required to be a good steward/decision maker for the company.

+ Fluent in Local Language and business proficient in English (verbal and written).

+ Excellent working knowledge of all applicable ICH/GCP regulations and Good Documentation Practices and ability to work within these guidelines.

+ Expertise in and excellent working knowledge of core trial management systems and tools Strong coordination and organizational skills.

+ High emotional intelligence.

+ Strong leadership skills with proven success in people management.

+ Excellent interpersonal and communication skills, conflict management.

+ Demonstrated ability to build relationships and to communicate effectively with internal stakeholders and external partners.

+ Fluency in both English and local language.

**Qualification & Experience:**

+ Minimum of 5 years experience within Clinical Research, preferred experience in the role of CTC, CRA or similar role.

+ Line management experience preferred or at the minimum team leader experience.

**Educational Requirements:**

Required:

+ Bachelor's Degree (or comparable) in Business Administration/ Life Science

**Preferred** :

+ Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or Clinical Research Management/Administration.

\#eligibleforerp

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:

$135,500.00 - $213,400.00

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:**

10%

**Flexible Work Arrangements:**

Remote

**Shift:**

Not Indicated

**Valid Driving License:**

No

**Hazardous Material(s):**

N/A

**Job Posting End Date:**

01/6/2025

***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:** R328871

This position is responsible for the coordination of a variety of research projects from pre-study implementation through study closure and will work independently in the acquisition of specimens; extraction and entry of patient data; maintenance of complete and accurate subject data and regulatory documentation; and analysis of data per protocol. This position provides administrative / regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments in accordance with all federal, state, regulatory agency, and specific institutional requirements.