Clinical Research Coordinator Senior/Intermediate

About the Program

The Division of Cardiovascular Medicine at the University of Michigan is expanding a nationally and internationally funded research program at the cutting edge of cardiovascular medicine. Led by Drs. Venkatesh Murthy and Sascha Goonewardena - whose work has appeared in leading journals including NEJM AI, JAMA, and Circulation - the program fuses artificial intelligence, advanced cardiac imaging, multiomics (proteomics, metabolomics, and genomics), and cardiometabolic disease biology to develop precision diagnostics and identify novel therapeutic approaches, with a particular focus on coronary microvascular disease and other cardiovascular conditions that disproportionately affect women and remain poorly served by existing diagnostic tools. This is a rare opportunity to join a high-impact, well-funded program doing science that matters.

Responsibilities

This position serves as the primary clinical research coordinator for the program, providing the regulatory and participant-facing infrastructure that connects patients to data and science. The Senior CRC will lead study start-up and ongoing regulatory management, coordinate participant recruitment and study visits for the program's cardiovascular biorepository, oversee data collection and REDCap operations, and mentor the Intermediate CRC.

Contribution to the development of process and tools 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, and Communication and Teamwork.

Specific responsibilities include:

• Lead study start-up and ongoing regulatory management: IRB submissions and amendments, MTAs, DUAs, and related regulatory documents; serve as primary study team liaison across participating sites
• Coordinate participant recruitment, screening, enrollment, scheduling, and study visit management for the cardiovascular biorepository
• Manage REDCap database and data collection workflows; ensure data quality, completeness, and audit-readiness
• Prepare and present written reports of regulatory status and study metrics to investigators
• Supervise and mentor the Intermediate CRC; assign and review work; support training on study protocols
• Coordinate with multi-site collaborators and support grant reporting and manuscript preparation
• Other duties as assigned

Supervision

Supervision Received: This position reports directly to the faculty Principal Investigators, Drs. Murthy and Goonewardena.

Supervision Exercised: Provides functional supervision of the Clinical Research Coordinator Intermediate.

Required Qualifications - Senior CRC

• CRC Senior requires Governance Committee review and approval
• Bachelor's degree in Health Science or an equivalent combination of related education and experience
• Certification through ACRP (CCRC) or SoCRA (CCRP); candidates external to UM must be eligible to sit for the exam at date of hire and must complete certification within 6 months of hire
• Minimum 5 years of directly related experience in clinical research and clinical trials
• Experience with IRB submissions, amendments, and renewals; regulatory document maintenance; MTAs and DUAs
• Experience with participant recruitment, screening, enrollment, scheduling, and informed consent processes
• Proficiency with REDCap or equivalent electronic data capture systems
• Strong organizational skills and attention to detail; ability to manage multiple concurrent studies and regulatory documents
• Ability to prepare and present clear written reports of work progress, regulatory status, and study metrics
• Strong written and verbal communication skills; ability to work with participants, clinical staff, and multi-site collaborators

Required Qualifications - Intermediate CRC

• Bachelor's degree in Health Science or an equivalent combination of related education and experience
• Certification through ACRP (CCRC) or SoCRA (CCRP); candidates external to UM must be eligible to sit for the exam at date of hire and must complete certification within 6 months of hire
• Minimum 3 years of directly related experience in clinical research and clinical trials

Desired Qualifications - Senior CRC

• 9+ years of directly related experience
• Experience in cardiovascular, imaging, or biospecimen-based research
• Familiarity with cardiac imaging study coordination or biorepository operations
• Experience supervising or mentoring junior research staff
• Familiarity with multi-site study coordination and cross-institutional regulatory requirements
• Experience with eResearch or similar IRB submission platforms
• CITI certification in human subjects research

Desired Qualifications - Intermediate CRC

• 6+ years of directly related experience

Work Schedule

Monday through Friday, standard business hours. This is an onsite position.

Benefits

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

Underfill Statement

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

Additional Information

We, the staff and faculty of the U-M Cardiovascular Center (CVC) team, are committed to advancing medicine and serving humanity through living and teaching our core values of Respect and Compassion; Collaboration; Innovation; and Commitment to Excellence. Each CVC employee is expected to understand and demonstrate that in every interaction we represent our entire organization in the care we provide and in the courtesies we extend to patients, families, and each respective team member. The CVC is dedicated to partnering with patients and families to deliver the safest and highest quality of health care.

The Division of Cardiovascular Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.