Research Coordinator

Full time

Position requires working fully on-site.

Department: Michigan Heart

• Competitive compensation, DAILYPAY
• Benefits effective Day One! No waiting periods.
• Full benefits package including Medical, Dental, Vision, PTO, Life Insurance, Short and Long-Term Disability
• Retirement savings plan with employer match and contributions
• Opportunity for growth and advancement throughout Trinity Health
• Tuition Reimbursement

The Research Coordinator independently coordinates, implements, and evaluates predominantly industry-sponsored clinical research studies conducted through Michigan Heart Research. This role manages the day-to-day operations of a complex research portfolio and serves as a primary operational partner to principal investigators, sponsors, and institutional stakeholders to ensure high-quality, compliant study conduct.

Shifts Available: Days

Status Available: Full-time, 40 hours/week

• 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.

• 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.

• Independently manages 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.
• Collaborates with principal investigators to evaluate study feasibility, including patient population availability, protocol requirements, operational impact, and resource needs.
• Coordinates study start-up activities, including regulatory submissions, sponsor and CRO communication, and institutional approvals in accordance with IRB, organizational, and regulatory requirements.
• Oversees participant identification, recruitment, screening, informed consent, enrollment, and retention activities in compliance with approved protocols and Good Clinical Practice (GCP).
• Conducts and coordinates study visits, data collection, source documentation, and timely entry of data into sponsor-required electronic data capture (EDC) systems.
• Ensures ongoing compliance with protocol requirements, IRB approvals, organizational policies, and applicable federal regulations, including FDA and ICH-GCP standards.
• Prepares for and participates in sponsor monitoring visits, audits, and regulatory inspections; addresses findings and supports corrective and preventive actions as needed.
• Reviews study documentation for accuracy, completeness, and timeliness; reconciles source documents with case report forms and communicates discrepancies to investigators and sponsors.
• Serves as a liaison between investigators, sponsors, CROs, and internal departments (e.g., clinical services, pharmacy, imaging, finance) to support efficient study execution.
• Supports study budget and financial activities, including collaboration on feasibility budgets, coverage analysis, invoice review, and tracking of study-related payments.
• Provides functional guidance and informal support to research coordinators and research staff related to study workflows, documentation standards, and sponsor expectations (no direct supervisory responsibility).
• Assists investigators and research staff with the development of study-related materials, reports, and publications as appropriate.