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Job Summary
The Clinical Research Coordinator leads (Intermediate level) or supports (Associate level) day-to-day participant recruitment, clinical visit operations, remote participant monitoring, and regulatory compliance across clinical research protocols. Under minimal supervision (Intermediate) or direct guidance (Associate), this position serves as a primary link between participants, clinicians, and the Principal Investigator to ensure efficient protocol execution and adherence to Good Clinical Practice (GCP) and regulatory standards. In this highly interactive, on-site position, direct interactions with study participants and healthcare professionals are required.
Responsibilities*
Protocol Execution & In-Person Clinical Visit Conduct
- Thoroughly review, comprehend, and execute study protocols and timelines.
- Coordinate and oversee clinical research visit activities per study protocols, including participant intake, biospecimen collection/processing, and cardiovascular/diagnostic testing.
- Ensure all clinical visit activities and source data are complete, accurate, and documented on time.
- Interact with the study team regularly to ensure participant safety and strict adherence to proper study conduct.
- Level Distinction: The Intermediate level independently oversees clinical visit flows and ensures protocol fidelity; the Associate level conducts clinical visits with direct supervision and guidance from senior staff or after training.
Participant Recruitment, Enrollment & Incentives
- Under supervision of the PI, develop and implement recruitment strategies, setting up and managing recruitment workflows within UM healthcare sites.
- Screen, evaluate, and engage potential participants in person (preferred), over the phone, or via email.
- Present study details, answer participants? questions, and conduct informed consent processes.
- Manage recruitment team schedules, maintain participant retention initiatives, and track/distribute study-related participant incentives.
- Level Distinction: The Intermediate level independently manages recruitment strategies and obtains consent; the Associate level assists with screening and obtains consent following training under supervision.
Regulatory, IRB & Compliance Management
- Understand research protocols and regulatory standards to maintain full procedural and data compliance.
- Under supervision of the PI, prepare, draft, and submit IRB documents, protocol amendments, consent form revisions, and regulatory submissions.
- Prepare, execute, and maintain study-specific SOPs, regulatory binders, and audit-ready documentation in accordance with GCP and FDA guidelines.
- Coordinate study audits with sponsors, the FDA, or governing bodies, assisting in the development and implementation of corrective action plans.
- Level Distinction: The Intermediate level independently manages IRB submissions and audit preparedness; the Associate level assists with regulatory drafting and binder upkeep under regular instruction.
Data Management & Quality Assurance
- Consistently collect, abstract, and record all study data accurately into electronic Case Report Forms (eCRFs) and tracking databases within required timeframes.
- Utilize and manage project-specific databases for participant recruitment, specimen inventory, and study supply tracking.
- Monitor, document, and report protocol deviations, safety incidents, and adverse events (including 24-hour SAE reporting) under investigator supervision.
- Level Distinction: The Intermediate level oversees data quality control and evaluates reported clinical data; the Associate level performs routine data entry and escalates data/safety discrepancies to senior team members promptly.
Study Operations, Training & Inter-Departmental Coordination
- Attend and participate actively in investigator oversight meetings.
- Serve as a primary point of contact and liaison between study sponsors, principal investigators, clinical care teams, and external regulatory bodies.
- Coordinate inter-departmental study requirements (e.g., radiology, pathology, cardiology, central labs) to ensure timely processing and central submission of clinical study materials.
- Develop training materials and tools to train project team members and clinic personnel on protocol requirements, visit schedules, and research tools.
- Develop and maintain specialized expertise in the target focus areas of research, keeping abreast of new regulations and industry standards.
- Level Distinction: The Intermediate level provides training and operational oversight to junior team members; the Associate level receives ongoing structured training and direction.
Required Qualifications*
Education & Credentials Requirements:
- Bachelor?s degree in health sciences, biology, nursing, public health, or other related field; OR an equivalent combination of professional credentials (e.g., RN, LPN) and healthcare experience.
- SOCRA (CCRP), ACRP (CCRC), or IATA certification is desired but not required.
- Knowledge of GCP and FDA clinical trial regulations is desired but not required.
Experience Requirements:
- Intermediate Level: Minimum 2 years of directly relevant clinical research coordinator experience required. Must demonstrate independent decision-making capabilities and working knowledge of protocol execution.
- Associate Level: Entry-level; no prior clinical research coordination experience required. Strong clinical, interpersonal, and/or organizational skills required.
Required Competencies:
Strong interpersonal skills to interact comfortably with participants, physicians, and clinical staff on site.
Proven organizational, problem-solving, and coordination skills with meticulous attention to detail and accuracy
Self-starter capable of taking initiative while knowing when to seek supervision.
Modes of Work
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
Underfill Statement
Position Leveling & Underfill Policy
This position is eligible to be underfilled at the Associate level for qualified candidates who do not yet have clinical research coordinator experience but are receptive to training and have strong clinical, interpersonal, and/or organizational skills. Core responsibilities are similar for both levels, but higher decision-making and operational autonomy are expected at the Intermediate level.
- Intermediate Level: Minimum 2 years of clinical research coordinator experience required. Position classification is Exempt (salaried). Requires working knowledge and independent decision-making on matters of significance without immediate supervision.
- Associate Level: No prior clinical research coordinator experience required (entry-level candidate). Position classification is Non-Exempt (hourly). Geared toward candidates who receive regular instruction and direction from senior team members.
FLSA & Overtime Note: If filled at the Intermediate level, this position is Exempt (salaried) and not eligible for overtime. If filled at the Associate level, this position is Non-Exempt and eligible for overtime depending on participant volume and clinical scheduling.
Background Screening
The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act.
U-M EEO Statement
The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.