Clinical Research Coordinator Senior

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Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Job Summary

This position serves as a Clinical Research Coordinator in the Pediatric Critical Care Medicine Division (PCCM/PICU) at the University of Michigan C.S. Mott Children's Hospital. Coordinator experience and mastery of all job duties on the Michigan Medicine CRC Career Ladder is required.

This position will provide leadership in the day-to-day implementation and coordination of complex clinical research activities, ensuring studies are conducted in accordance with protocols, Good Clinical Practice (GCP), institutional policies, and applicable regulatory requirements. The CRC Lead will work closely with PCCM Project Managers and Principal Investigators, multidisciplinary clinical partners, internal and external study teams, and other stakeholders to ensure high-quality and efficient execution of the PCCM clinical research portfolio.

The Clinical Research Coordinator will also serve as the regulatory lead for a UG3-funded, multi-center research consortium that will establish a harmonized U.S. cohort of children hospitalized with viral lower respiratory tract infections across nine sites and follow participants over a period of time. In this role, the CRC Lead will coordinate and oversee regulatory activities, support harmonization of regulatory processes across participating sites, and work closely with the Principal Investigator, study leadership, and participating research teams to ensure compliance with applicable regulatory and study requirements.

Responsibilities*

Characteristic Duties and Responsibilities:

Set-up unit wide systems or policies and manage a team of clinical research professionals (or portfolios) in all 8 competency domains is expected:

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

Clinical Research Coordination and Study Leadership

• Serve as a lead clinical research coordinator for federally funded and investigator-initiated research clinical research studies
• Coordinate and oversee the day-to-day implementation of study protocols, ensuring adherence to protocol requirements, GCP, institutional policies, and applicable regulatory requirements.
• Develop and implement processes, tools, and workflows to support efficient and consistent study execution.
• Coordinate study activities across investigators, research staff, clinical teams, participants, and other internal and external stakeholders.
• Perform study procedures and clinical research activities at an advanced level and serve as a resource to other members of the study team.
• Identify operational challenges and develop solutions to improve study efficiency, participant experience, and data quality.
• Monitor study progress, timelines, enrollment, and other key study metrics and communicate updates and concerns to the appropriate leadership.
• Assist with study start-up, implementation, ongoing conduct, and close-out activities as appropriate.

Regulatory and Compliance Responsibilities

• Coordinate and oversee regulatory activities associated with assigned studies.
• Maintain and monitor regulatory documentation and study files for completeness, accuracy, and compliance.
• Support IRB submissions, continuing reviews, amendments, reports, and other regulatory requirements.
• Monitor compliance with protocol requirements and participant safety reporting requirements.
• Identify and escalate potential compliance, safety, or protocol issues to the appropriate study leadership.
• Develop processes, tools, and training to support regulatory compliance and participant safety.

Supervision Received:

This position reports directly to the Clinical Research Project Manager.

Supervision Exercised:

This position manages a portfolio of multi-site clinical research in which the University of Michigan is the lead center.

Required Qualifications*

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.
• Minimum of 5 years of directly related experience in clinical research and/or clinical trials.
• Experience with regulatory submissions, IRB processes, and research compliance.
• ACRP Certified Clinical Research Coordinator (CCRC), SOCRA Certified Clinical Research Professional (CCRP), or equivalent certification, or eligibility to obtain certification within six months of hire.
• Demonstrated experience coordinating clinical research studies and managing multiple priorities.
• Demonstrated knowledge of clinical research processes, GCP, regulatory requirements, and participant safety considerations.
• Demonstrated ability to work independently and exercise sound judgment when managing complex research activities.
• Strong organizational, communication, problem-solving, and interpersonal skills.
• Demonstrated attention to detail and commitment to data quality and research integrity.
• Ability to effectively collaborate with investigators, research staff, clinical teams, and other stakeholders.

CRC - Senior

• CRC Governance Committee review and approval

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.

• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed within six months of date of hire. (Please review eligibility criteria from SoCRA orACRP prior to applying.)

• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)

CRC - Intermediate

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.

• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed within six months of date of hire. (Please review eligibility criteria from SoCRA orACRP prior to applying.)

• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)

CRC - Associate

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.

• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed within six months of date of hire. (Please review eligibility criteria from SoCRA orACRP prior to applying.)

• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Desired Qualifications*

• Experience working with NIH-funded research or federally funded clinical research.
• Experience supporting complex or multi-component clinical research studies.
• Experience developing research processes, standard operating procedures, work aids, and training materials.
• Experience with clinical research databases and electronic data capture systems.
• Demonstrated experience with quality improvement and/or research process optimization.

CRC - Senior

• 9+ years of direct related experience

CRC - Intermediate

• 6+ years of direct related experience

CRC- Associate

• 4+ years of direct related experience

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Work Schedule

The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. However, the position will require flexibility in work hours to support research activities, participant needs, and study-related activities that may occasionally occur outside of traditional business hours. Weekend coverage may be required as needed to support participant enrollment.

Underfill Statement

This position may be underfilled at the CRC-Intermediate or CRC-Associate titles based on selected candidates, qualifications, and the review and approval of the Michigan Medicine CRC Governance Board.

Additional Information

The use of the CRC-Lead and CRC-Senior title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.