Clinical Research Coordinator I / Assistant Clinical Research Coordinator

University Of Michigan - Ann Arbor, MI

Full-time - Entry Level

Remote - Ann Arbor, MI

Educational Services

About the position

The Clinical Research Coordinator I / Assistant Clinical Research Coordinator at the University of Michigan is responsible for independently coordinating simple to moderately complex clinical research studies. This role involves supporting a portfolio of projects, ensuring compliance with ethical standards, and maintaining effective communication with study teams and regulatory bodies. The position requires a strong understanding of clinical research processes and the ability to manage data and participant interactions effectively.

Responsibilities

• Assist study team with clinical research coordination including identifying, screening, consenting, and enrolling subjects.
• Collect specimens and monitor study subjects, ensuring the integrity of specimens throughout the process.
• Perform data management and results reporting, including entering information into Case Report Forms (CRFs).
• Prepare IRB submissions, including initial applications, amendments, and progress reports.
• Communicate with sponsors regarding clinical trial progress, billing issues, and recruitment strategies.
• Act as a liaison between study teams and regulatory agencies, maintaining accurate communication on costs and policies.
• Provide support for audits and monitor visits, ensuring compliance with regulations.
• Mentor and train other CRC staff through presentations and guidance.
• Organize study-related materials and equipment in preparation for research activities.

Requirements

• Associate's Degree or equivalent in combined education and clinical research experience.
• Minimum of 1+ years direct related experience or advanced degree in health-related areas or 3 years of related human subjects experience.
• High School Diploma or GED for Clinical Research Assistant.

Nice-to-haves

• Bachelor's Degree in Health Science or equivalent combination of education and experience.
• Understanding of medical terminology.
• Knowledge of Michigan Medicine policies and practices.
• Familiarity with OnCore, Epic, MiCHART, and eResearch applications.
• PEERS, CITI, or NIH Protection of Human Subjects Training Certification.
• Experience with local and central IRB application processes.

Benefits

• Mobile/Remote work options available.
• Support for diversity, equity, and inclusion initiatives.
• Commitment to a safe and respectful work culture.