Research Coordinator

About the Role

This position requires working fully on-site within the Michigan Heart Research department at Trinity Health Ann Arbor. The Research Coordinator independently coordinates, implements, and evaluates predominantly industry-sponsored clinical research studies, managing day-to-day operations of a complex research portfolio.

Responsibilities

• Independently manage all phases of assigned clinical research studies, including feasibility assessment, start-up, active conduct, monitoring readiness, and close-out, with a primary focus on sponsor-initiated trials.
• Collaborate with principal investigators to evaluate study feasibility, including patient population availability, protocol requirements, operational impact, and resource needs.
• Coordinate study start-up activities, including regulatory submissions, sponsor and CRO communication, and institutional approvals in accordance with IRB, organizational, and regulatory requirements.
• Oversee participant identification, recruitment, screening, informed consent, enrollment, and retention activities in compliance with approved protocols and Good Clinical Practice (GCP).
• Conduct and coordinate study visits, data collection, source documentation, and timely entry of data into sponsor-required electronic data capture (EDC) systems.
• Ensure ongoing compliance with protocol requirements, IRB approvals, organizational policies, and applicable federal regulations, including FDA and ICH-GCP standards.
• Prepare for and participate in sponsor monitoring visits, audits, and regulatory inspections; address findings and support corrective and preventive actions as needed.
• Review study documentation for accuracy, completeness, and timeliness; reconcile source documents with case report forms and communicate discrepancies to investigators and sponsors.
• Serve as a liaison between investigators, sponsors, CROs, and internal departments (e.g., clinical services, pharmacy, imaging, finance) to support efficient study execution.
• Support study budget and financial activities, including collaboration on feasibility budgets, coverage analysis, invoice review, and tracking of study-related payments.
• Provide functional guidance and informal support to research coordinators and research staff related to study workflows, documentation standards, and sponsor expectations (no direct supervisory responsibility).
• Assist investigators and research staff with the development of study-related materials, reports, and publications as appropriate.

Requirements

• Bachelor’s degree in a related science, healthcare, or business field. Master’s degree preferred.
• Minimum of three years of clinical research experience, with preference for experience in industry-sponsored clinical trials.
• Experience with EDC systems, electronic medical records (EPIC preferred), and clinical trial documentation.

Skills

• Strong working knowledge of clinical research operations, regulatory requirements, and GCP.
• Demonstrated ability to independently manage multiple sponsored studies with competing priorities.
• Excellent written and interpersonal communication skills.
• Ability to work independently while collaborating effectively within a multidisciplinary research team.

Benefits

• Competitive compensation with DailyPay benefits effective from day one.
• Full benefits package including medical, dental, vision, PTO, life insurance, short and long-term disability.
• Retirement savings plan with employer match and contributions.
• Opportunities for growth and advancement throughout Trinity Health.
• Tuition reimbursement.

Schedule

Full-time, 40 hours per week, day shift.

Physical and Mental Requirements

This role requires the ability to manage multiple priorities, work independently, and collaborate effectively within a team. Strong organizational and communication skills are essential.