"Clinical Research Coord Assoc/ Tech/ Assist"

A Precision Health program focused on vascular diseases at the University of Michigan Medical School is seeking a highly motivated and experienced Clinical Research Coordinator to join our team. This is a multi-disciplinary collaboration across the medical campus with the primary appointment in the Department of Internal Medicine, Division of Cardiovascular Medicine at Michigan Medicine/University of Michigan. The selected individual will serve as the primary coordinator for the Michigan Medicine Arterial Dysplasia Precision Health Network including multi-center collaborations. This individual will be responsible for overseeing participant enrollment at the University of Michigan and across the United States through an online enrollment structure, participate in the biospecimen collection processes, and conduct data collection from participants and medical records.

Successful candidates will join a highly collaborative research team that values transformative science and outstanding patient care.

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work.

Clinical Coordination Responsibilities

• Oversee research participant enrollment, conduct and document informed consent, implement in-person and online participant recruitment activities, facilitate biospecimen collections, and serve as the primary point of contact for study participants
• Lead enrollment tracking and progress monitoring across multiple sites
• Provide guidance and mentorship to students supporting participant-facing activities

Data Coordination Responsibilities

• Manage study-related REDCap electronic data capture projects
• Serve as the primary individual responsible for participant data collection, distribution of study surveys and questionnaires, and data abstraction from medical records
• Supervise a dedicated database manager, ensuring integrity, security, and quality control of research data

Regulatory Coordination Responsibilities

• Conduct research-related IRB tasks such as continuing reviews, ORIO reports, and study amendments
• Assure compliance with institutional, state, and federal policies and guidelines and protection of PHI
• Independently draft and submit regulatory documents and correspondence

Supervisory and Leadership Responsibilities

• Oversee, train, and supervise student research assistants and the database manager
• Establish accountability systems to ensure timely and accurate execution of all delegated tasks
• Act as the operational lead, liaising between the PI, research staff, and collaborators

Other Administrative Responsibilities and Trainings

Independent knowledge, skills, and abilities within 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.

Supervision Received: This position reports directly to a Faculty Principal Investigator.

Supervision Exercised: Provides functional supervision to temporary staff, student research assistants, and a database manager.

Associate Level Requirements: Bachelor's degree in Health Science or equivalent, certification as CCRC or CCRP within six months, minimum 2 years of clinical research experience, experience with IRB and supervision.

Technician Level Requirements: Associate degree or equivalent, minimum 1 year of clinical research experience.

Assistant Level Requirements: High school diploma or GED.

Additional desirable experience includes REDCap, biospecimen management, and multi-site studies. This is a full-time position, primarily onsite with occasional remote work.