Clinical Research Coordinators

**Job Description**

**Position Description:**

This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 Clinical Research Associates (CRAs) and to ensure excellent study and site performance with strict adherence to local regulations, company Standard Operating Procedure (SOPs) and International Conference on Harmonization Good Clinical Practice (ICH GCP.)

As line manager, the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situation of low or non-performance.

The role will work at country level with other local stakeholder e.g. CRM to ensure alignment and development of the country capabilities. The role will collaborate with country Partner Line Manager's (PLMs) to ensure alignment across all monitoring functions. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.

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

+ Work allocation, staff development and performance appraisal.

+ Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.

+ Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.

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

+ Attend local Investigator Meetings if requested to.

+ Interface with GCTO partners on clinical trial execution.

+ Escalates site performance issues to CRM and Clinical Research Director CRD.

+ People and Resource Management:

+ Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.

+ Support and resolve escalation of issues from CRAs.

+ Liaise with local HR and finance functions as required.

+ Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.

+ Provides training, support and mentoring to the CRA to ensure continuous development.

+ Ensures CRA compliance to corporate policies, procedures and quality standards

Extent of Travel: up to 50%

**Core Competency Expectations:**

+ Ability to work independently and in a team environment

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

+ History of strong performance

+ 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

**Behavioral Competency Expectations:**

+ 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 external customers (e.g. sites and investigators)

+ Influencing skills

**Position Qualifications:**

**Education Minimum Requirement:**

+ Required: Bachelor’s degree in science

+ Preferred: Advanced degree, (e.g. BA/BS or higher) with a strong emphasis in science and/or biology

**Required Experience and Skills:**

+ Minimum of 5 years´ experience within Clinical Research

+ Minimum of 3 years’ experience as CRA monitoring clinical trials

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

**\#EligibleforERP**

**MRLGCTO**

**NOTICE** **FOR** **INTERNAL** **APPLICANTS**

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

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, generally Tuesday, Wednesday and either Monday or 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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 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/) .

**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:**

Yes

**Hazardous Material(s):**

na

**Job Posting End Date:**

07/11/2024

***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.**

**Job Posting End Date:** 07/11/2024

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:** R302827

**Permanent Remote position. Candidate can be located anywhere in the U.S.**

**Wolters Kluwer FCC** division is looking for a **Specialized Regulatory Consultant** to work within our CRA and Fair Lending Advisory Services Group.

**The Advisory Services Group** offers consulting services to banks and financial institutions of all sizes to provide the expertise necessary to compete and thrive in today’s challenging regulatory environment. Our consultants combine innovative thinking with our unrivaled first-hand industry knowledge to offer our clients a wide array of consulting services in the financial services industry.

As a **Specialized Consultant,** you will be responsible for providing consulting, advisory, analytical analysis, product implementation support and training services to assist clients in their efforts to meet responsibilities under consumer compliance laws and regulations, including consumer protection and Fair Lending laws, CRA, HMDA and UDAAP. In this position, you will also use and assist clients with the utilization of Wolters Kluwer Financial Services (WKFS) applications (CRA Wiz, CRA Wiz SaaS, Small Biz Wiz, Fair Lending Wiz SaaS, and Fair Lending Wiz).

**Essential Duties & Responsibilities:**

+ Ability to work collaboratively with financial institutions to gain understanding of client need and identify solutions to analyze data, communicate findings, write reports, and work within Wolters Kluwer advisory and technology solutions to assess regulatory obligations related to the Community Reinvestment Act (CRA), Fair Lending laws and regulations, Dodd-Frank 1071, CRA Modernization, and the Home Mortgage Disclosure Act (HMDA).

+ Support Fair Lending consulting and advisory services such Fair Lending Risk Reviews, Redlining Risk Review and Comparative File Reviews on a wide variety of Loan Register types.

+ Support CRA consulting and advisory services such as CRA Performance Assessments, Performance Context, Mapping, and Data Integrity Reviews on a wide variety of Loan Register types.

+ Use of Wolters Kluwer software solutions including CRA Wiz SaaS, Small Biz Wiz, and Fair Lending Wiz SaaS.

+ Maintain knowledge of CRA regulatory guidance (including the New Rule 1071 and CRA Modernization) to support client needs.

+ Maintain knowledge of Fair Lending regulatory guidance.

+ Independently perform Quality Control on CRA and Fair Lending client deliverables.

+ Train end users on utilizing WKFS products or services to meet regulatory requirements, including CRA Wiz SaaS, Small Biz Wiz and Fair Lending Wiz SaaS.

+ Participate in and provide constructive feedback to leadership on current regulatory changes and trends.

+ Represent WKFS and participate in the Wolters Kluwer CRA and Fair Lending Colloquium.

+ Maintain strong interpersonal, team-oriented, and collaborative relationship skills.

**Minimum Qualifications:**

+ Bachelor’s degree in business, mathematics, finance, or related discipline

+ A minimum of 5 years of experience working in compliance/fair lending/CRA at a financial institution, bank regulatory agency, or as a consulting firm specializing in financial institution compliance

+ Demonstrated knowledge of consumer protection laws and regulations, including CRA, Fair Lending, HMDA, 1071, CRA Modernization and UDAAP

+ Experience in understanding the lending process, including but not limited to CRA requirements, underwriting and pricing of mortgage, consumer, indirect, and commercial loans

+ Experience with CRA and Fair Lending software (WK Wiz Software preferred but not required)

+ Understanding of statistics and experience with technical analysis associated with Fair Lending and CRA regulations.

+ Ability to pass a background check

**Preferred Qualifications (includes minimum)**

+ Experience delivering consulting services or conducting bank examinations.

+ Excellent ability to monitor, interpret and communicate regulatory changes.

+ Proficiency in Spanish

+ Certified Regulatory Compliance Manager (CRCM) or equivalent (Examiner Commission)

**Additional Skills, Knowledge & Abilities:**

+ Strong technical writing, presentation, training, facilitation, and interpersonal skills;

+ Strong analytical, reasoning, troubleshooting and team-based problem-solving skills;

+ Ability to work both collaboratively and autonomously on multiple projects;

+ Demonstrates a clear understanding of legal ethics and the ability to use good judgment, discretion, and confidentiality;

+ Ability to analyze information, create conclusions and communicate such information effectively in both written and oral formats;

+ Strong customer services skills and the ability to manage the client relationship, analyzing and communicating customer needs and requirements;

+ Strong independent time management and ability to prioritize and critical deadlines;

+ Availability for limited travel;

+ Ability to review current processes and data flow and recommend best practices for ongoing use of systems;

+ Ability to clearly document client operational and compliance processes;

+ Expert user of Microsoft Office tools including Excel, Word, and PowerPoint;

+ Ability to manipulate data using SQL and/or Oracle tools;

+ Ability to crystallize ideas and communicate them to others.

EQUAL EMPLOYMENT OPPORTUNITY Wolters Kluwer U. S. Corporation and all of its subsidiaries, divisions and customer/business units is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

As a member of the Prospect Research and Development team, the Prospect Research Coordinator III is responsible for carrying out three primary functions: prospect research, data management, and administrative department coordination.
The Prospect Research Coordinator III will report to the Director of Prospect Research and Development and work directly with senior researchers coordinating projects, sourcing corporate leads, researching family foundations, qualifying individuals for portfolio assignment, building donor profiles, and managing news alerts.
Additionally, the coordinator will have the opportunity to work with fundraisers, as well as leadership.
This position is also responsible for managing basic administrative tasks, such as scheduling, organizing meetings and taking minutes, managing invoices, documenting policies.
The ideal candidate must be highly organized, extremely detail oriented, and demonstrate exceptional time management, critical thinking, and problem-solving skills.
This position requires the ability to take initiate, work independently and collaboratively, manage multiple competing and changing priorities in a fast paced, deadline driven environment.
The ideal candidate would have experience with Raiser’s Edge, is highly proficient using Microsoft Office suite, and familiar with project management tools like Smartsheet is a plus.
• Bachelor’s degree preferred.
• Two to three years prior experience in prospect research, development, library research or information related field.
• Any combination of acceptable education and experience, which has provided the necessary knowledge and skills to fulfill the requirements of the position, may be considered.
• Exceptional computer skills and demonstrated background in internet-based research.
• Proficiency in Microsoft Office suite. Experience with relational databases.
• Experience with Raiser’s Edge is preferred.
• Familiarity with project management tools like Smartsheet is a plus.
• Knowledge of the range of resources available to prospect researchers and the ability to apply those resources in an organized and purposeful manner.
• Exhibits strong customer service, organizational and exceptional time management skills.
• Ability to communicate effectively in customer-oriented environment.

The Coordinator III’s primary responsibility is to assist with managing relationships, partnerships, programs, events and campaigns that result in growing annual revenue for the Foundation. The Coordinator III collaborates with colleagues throughout the Foundation and/or hospital to help deliver first-class programs, events, recognition, and service to internal and external donors. The Coordinator III will take a lead role on project/program execution.

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 14,000 team members, 3,700 affiliated providers and hundreds of 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. Provides data 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 in the coordination and management of inpatient and outpatient studies, according to protocol and sponsor amendments. Assists with subject follow-up for clinical protocols. Works with the Research Staff to assist with the tracking of study progress and development of periodic status reports. Assist with preparation of annual reports and statistical information on clinical research as required by Institute, System, IRB or investigators. Obtains all reports and submits data forms and pathology materials according to protocol requirements. Identifies the achievement of key milestones such as draft or final database to the Research Staff. Provides assistance as needed to peers to ensure that study deadlines are met. Provides support to Research Staff in execution of pharmaceutical or investigator initiated clinical protocols. Handles and labels samples and ships samples according to protocol requirements. Facilitates ongoing set up and closing. 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. Assists the Research Staff with the coordination and completion of submission packets for the IRB. 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 Experience 2 years experience working with data, or a technician working in a healthcare environment, or currently enrolled in/completed a research educational program 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 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 14,000 team members, 3,700 affiliated providers and hundreds of 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. Provides data 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 in the coordination and management of inpatient and outpatient studies, according to protocol and sponsor amendments. Assists with subject follow-up for clinical protocols. Works with the Research Staff to assist with the tracking of study progress and development of periodic status reports. Assist with preparation of annual reports and statistical information on clinical research as required by Institute, System, IRB or investigators. Obtains all reports and submits data forms and pathology materials according to protocol requirements. Identifies the achievement of key milestones such as draft or final database to the Research Staff. Provides assistance as needed to peers to ensure that study deadlines are met. Provides support to Research Staff in execution of pharmaceutical or investigator initiated clinical protocols. Handles and labels samples and ships samples according to protocol requirements. Facilitates ongoing set up and closing. 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. Assists the Research Staff with the coordination and completion of submission packets for the IRB. 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 Experience 2 years experience working with data, or a technician working in a healthcare environment, or currently enrolled in/completed a research educational program Required

**Overview**

**Overview:**

This role supports clinical program creation, maintenance, and client implementations by developing and managing the clinical components of our care programs. This includes overseeing content development, clinical product design, and strategic decision-making that result in delivery of clinical programs and related supporting materials to relevant organizational stakeholders and drive ongoing client value and success. This Clinical Program Manager will be responsible for ensuring the clinical integrity of our clinical programs while optimizing for a dynamic, mobile platform. They will report to the VP, Content Operations, and work closely with this role to identify critical client deliverables and appropriate prioritization of responsibilities. A successful Clinical Program Manager will demonstrate effective client communication and strategic decision-making that appropriately balances the user experience, client needs and organizational and business priorities, while maintaining the clinical quality and standards of our product. Because you will contribute across many facets of our team's needs, you will need to be able to contribute to both the strategy and tactical, collaborate effectively across the organization, and demonstrate flexibility and strong problem-solving.

**About our "Wellframe" Product:**

_With Wellframe,_ we reimagine healthcare relationships through a new approach that uses high-tech to deliver the high-touch support people need, when and where they need it. We call it Digital Health Management. Our comprehensive suite of Digital Health Management solutions for care management, advocacy, and navigation help organizations forge more meaningful connections with members, across their healthcare journey. Wellframe was founded to counter a pressing industry problem: the healthcare system has struggled to find ways to support people in between care settings, at scale. We believe health plans are in the best position to advocate for their members as they navigate their health and care, but know that technology alone can’t help us achieve this ambition. That’s why our team of physicians, clinicians, public health experts, data scientists, engineers, and healthcare industry experts ensure our patented technology works in service of the person-to-person connections that make healthcare work best. The complete suite of solutions from HealthEdge delivers a digital foundation for payers specifically designed to fuel a digital transformation, reduce costs, and improve both clinical outcomes and the member experience.

**What you bring:**

+ **RN/NP/MSN** with **10+ years of health care experience** **required** ; ideally with a variety of experience in primary care, chronic disease management and/or public health

+ Prior experience in **clinical program design** , evaluation and implementation **required**

+ Prior experience **developing patient education or health literacy materials required**

+ Strong relationship management skills and **client-facing and/or consulting experience**

+ Strong written, verbal and presentation communication skills

+ **Knowledge of payer, provider, and other key stakeholders in the healthcare market landscape**

+ A passion for health, health care, and innovation

+ A self-starter who can manage his or her own daily workload, operate well under pressure, and balance competing priorities

+ Works well in a fast-paced, agile environment

+ Adept problem-solver motivated to find solutions and success for our clients

+ Confident, pragmatic decision-maker and leader

**What you will do:**

+ Support client implementations and customization requests (40%)

+ Collaborate cross functionally to uncover and address client learning needs, implementation requirements and measures of success

+ Provide client-specific recommendations to Client Strategy & Operations Team that demonstrate continuous learning and adaptation of implementation strategies

+ Effectively communicate to client our best practices for clinical program utilization, product functionality and customizations through the development of clinical collateral and/or presentations

+ Evaluate and prioritize key decisions around client customization that balance internal best practices with client happiness and success

+ Navigate client requests that extend beyond the typical scope of client customizations; responsible for discovery with stakeholders, identifying strategic considerations, and outlining recommendations.

+ Oversee clinical aspects of program maintenance and standardization projects (40%)

+ Collaborate with Director, Content Operations to review and evaluate tickets for clinical risk or clinical improvement opportunities.

+ Lead the clinical review of existing clinical program content and references in order to evaluate accuracy and alignment with updates to clinical practice and guidelines.

+ Identify and propose recommendations for clinical content or design updates that mitigate clinical risk and improve user experience.

+ Demonstrate effective prioritization of decisions that weigh clinical necessity against business priorities.

+ Develop and design clinical content and user experience for new program development (20%)

+ Spearhead discovery with internal and external stakeholders to capture client requirements, population needs, and program design considerations.

+ Outline a comprehensive health literacy curriculum and author corresponding surveys & alerts that leverage evidence-based guidelines, clinical best practices and key quality improvement measures.

+ Develop, document, and ensure the consistent use of Wellframe clinical best practices in our clinical programs.

_HealthEdge commits to building an environment and culture that supports the diverse representation of our teams. We aspire to have an inclusive workplace. We aspire to be a place where all employees have the opportunity to belong, make an impact and deliver excellent software and services to our customers._

**Geographic Responsibility:** **This is a remote role with EST Working Hours.**

**Type of Employment:** Full-time, permanent

**FLSA Classification (USA Only):** Exempt

**Work Environment:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job:

+ The employee is occasionally required to move around the office. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

+ Work across multiple time zones in a hybrid or remote work environment.

+ Long periods of time sitting and/or standing in front of a computer using video technology.

+ May require travel dependent on company needs.

_The above statements are intended to describe the general nature and level of the job being performed by the individual(s) assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required. HealthEdge reserves the right to modify, add, or remove duties and to assign other duties as necessary. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position in compliance with the Americans with Disabilities Act of 1990. Candidates may be required to go through a pre-employment criminal background check._

_HealthEdge is an equal opportunity employer. We are committed to workforce diversity and actively encourage all qualified persons to seek employment with us, including, but not limited to, racial and ethnic minorities, women, veterans and persons with disabilities._

_\#LI-Remote_

**Job Locations** _US-Remote_

**ID** _2023-3831_

**Category** _Hidden (28999)_

**Position Type** _Full-Time_

HealthEdge provides equal employment opportunities to all employees and applicants for employment 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.

**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**

Monday - Friday (8:00am - 5:00pm)

**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.

**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). 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.

**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 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

**Benefits Eligible**

Yes

**Schedule**

Full Time

**Hours/Pay Period**

40

**Schedule Details**

Monday - Friday (8:00am - 5:00pm)

**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.

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 14,000 team members, 3,700 affiliated providers and hundreds of 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. Provides data 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 in the coordination and management of inpatient and outpatient studies, according to protocol and sponsor amendments. Assists with subject follow-up for clinical protocols. Works with the Research Staff to assist with the tracking of study progress and development of periodic status reports. Assist with preparation of annual reports and statistical information on clinical research as required by Institute, System, IRB or investigators. Obtains all reports and submits data forms and pathology materials according to protocol requirements. Identifies the achievement of key milestones such as draft or final database to the Research Staff. Provides assistance as needed to peers to ensure that study deadlines are met. Provides support to Research Staff in execution of pharmaceutical or investigator initiated clinical protocols. Handles and labels samples and ships samples according to protocol requirements. Facilitates ongoing set up and closing. 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. Assists the Research Staff with the coordination and completion of submission packets for the IRB. 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 Experience 2 years experience working with data, or a technician working in a healthcare environment, or currently enrolled in/completed a research educational program Required

**Job Description**

This role will be key to ensure strong monitoring in our clinical trials. Under the oversight of the CRD or Head of Site Management and Monitoring, the person is responsible to manage a team of 6-14 CRAs and to ensure excellent study and site performance with strict adherence to local regulations, company SOPs and ICH GCP.

As line manager the role is critical to continuously develop key talents by providing training, support and mentoring to the CRAs and properly manage situation of low or non-performance.

The role will work at country level with other local stakeholder e.g. CRM to ensure alignment and development of the country capabilities. The role will collaborate with country PLMs to ensure alignment across all monitoring functions. The person contributes to HQ capacity/resource planning activities to ensure efficient allocation of resources and work.

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

+ Work allocation, staff development and performance appraisal.

+ Provides input for capacity planning, including reporting of current manpower and forecasting of CRA capacity and needs, to provide efficient use of resources.

+ Work with CRAs, PLMS and other functions to ensure consistency of processes and protocol implementation across the country, to reduce variability and provide predictability.

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

+ Attend local Investigator Meetings if requested to.

+ Interface with GCTO partners on clinical trial execution.

+ Escalates site performance issues to CRM and Clinical Research Director CRD.

**People and Resource Management:**

+ Manage CRA – career development, performance reviews, etc., including addressing low performance situations, and taking appropriate actions.

+ Support and resolve escalation of issues from CRAs.

+ Liaise with local HR and finance functions as required.

+ Contribute to HQ capacity/resource planning activities to ensure efficient allocation of resources and work. Manage local conflicts between resource and work.

+ Provides training, support and mentoring to the CRA to ensure continuous development.

+ Ensures CRA compliance to corporate policies, procedures and quality standards

**Extent of Travel:**

+ up to 50%

**Qualifications, Skills & Experience:**

**CORE Competency Expectations:**

+ Ability to work independently and in a team environment

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

+ History of strong performance

+ 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

**Behavioral Competency Expectations:**

+ 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 external customers (e.g. sites and investigators)

+ Influencing skills

**Experience Requirements:**

**Required:**

+ Minimum of 5 years´ experience within Clinical Research

+ Minimum of 3 years’ experience as CRA monitoring clinical trials

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

**Educational Requirements:**

**Required:**

+ Bachelor’s degree in Science

​ **Preferred:**

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

**\#EligibleforERP**

**MRLGCTO**

**NOTICE** **FOR** **INTERNAL** **APPLICANTS**

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

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, generally Tuesday, Wednesday and either Monday or 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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 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/) .

**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:**

Yes

**Hazardous Material(s):**

NA

**Job Posting End Date:**

06/18/2024

***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.**

**Job Posting End Date:** 06/18/2024

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:** R299140