Clinical Research Coordinator Senior/Intermediate

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 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. 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. This position requires CRC Advisory Committee review and approval prior to posting per Michigan Medicine policy. This position may be underfilled at the CRC-Intermediate title based on selected candidates? qualifications and the review and approval of the Michigan Medicine CRC Governance Board. Responsibilities* Contribution to the development of process and tools in all 8 competency domains is expected: Scientific Concepts and Research DesignEthical Participant Safety ConsiderationsInvestigational Products Development and RegulationClinical Study Operations (GCPs)Study and Site ManagementData Management and InformaticsLeadership and ProfessionalismCommunication 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 sitesCoordinate participant recruitment, screening, enrollment, scheduling, and study visit management for the cardiovascular biorepositoryManage REDCap database and data collection workflows; ensure data quality, completeness, and audit-readinessPrepare and present written reports of regulatory status and study metrics to investigatorsSupervise and mentor the Intermediate CRC; assign and review work; support training on study protocolsCoordinate with multi-site collaborators and support grant reporting and manuscript preparationOther duties as assigned 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* CRC - Senior CRC Governance Committee review and approvalBachelors degree in Health Science or an equivalent combination of related education and experience is necessary. 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. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. Experience with IRB submissions, amendments, and renewals; regulatory document maintenance; MTAs and DUAsExperience with participant recruitment, screening, enrollment, scheduling, and informed consent processesProficiency with REDCap or equivalent electronic data capture systemsStrong organizational skills and attention to detail; ability to manage multiple concurrent studies and regulatory documentsAbility to prepare and present clear written reports of work progress, regulatory status, and study metricsStrong written and verbal communication skills; ability to work with participants, clinical staff, and multi-site collaborators CRC - Intermediate Bachelors degree in Health Science or an equivalent combination of related education and experience is necessary. 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. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. Desired Qualifications* CRC - Senior 9+ years of directly related experienceExperience in cardiovascular, imaging, or biospecimen-based researchFamiliarity with cardiac imaging study coordination or biorepository operationsExperience supervising or mentoring junior research staffFamiliarity with multi-site study coordination and cross-institutional regulatory requirementsExperience with eResearch or similar IRB submission platformsCITI certification in human subjects research CRC - Intermediate 6+ 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 day2:1 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 Work Schedule: Monday through Friday, standard business hours. This is an onsite position. 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. 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.