Research Coordinator
IHA
Description Position requires working fully on-site. Employment Type Full time Shift Day Shift Department Michigan Heart Location Trinity Health Ann Arbor Total Rewards And Benefits 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 Position Purpose 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 Required Qualifications Education Bachelor’s degree in a related science, healthcare, or business field. Master’s degree preferred. Experience 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. Physical And Mental Requirements And Working Conditions 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. What You Will Do 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. Our Commitment Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law. #J-18808-Ljbffr IHA
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