Clinical Research Coordinator
M.I.N.D•Farmington Hills, MI
•$20 - $23•Onsite
About The Position
The Clinical Research Study Coordinator is responsible for the day-to-day coordination and management of clinical research studies conducted within the neurology infusion center. This role ensures protocol adherence, accurate data collection, regulatory compliance, and effective communication between investigators, sponsors, CROs, clinical staff, and patients. The Study Coordinator supports study start-up, participant screening and enrollment, visit coordination, data management, and regulatory documentation to ensure high-quality research execution and patient safety.
Requirements
- Associate’s or Bachelor’s degree in a health-related or science field preferred
- Prior experience in clinical research coordination preferred
- Knowledge of GCP, IRB processes, and clinical research regulations preferred
- Experience with EMR and EDC systems preferred
- Strong organizational, communication, and documentation skills
Responsibilities
- Coordinate assigned clinical research studies from start-up through close-out
- Screen, recruit, and enroll eligible research participants according to protocol criteria
- Schedule and coordinate study visits, procedures, infusions, labs, and follow-ups
- Ensure protocol-specific procedures are completed accurately and within required timelines
- Assist with study start-up activities, including feasibility assessments, site readiness tasks, and workflow development
- Prepare and maintain regulatory documents including investigator site files (ISFs), delegation logs, training logs, and essential documents
- Support IRB submissions, amendments, renewals, and continuing reviews as directed
- Ensure staff training documentation is current and protocol-specific training is completed
- Accurately collect, enter, and maintain study data in EDC systems and source documents
- Ensure data accuracy, completeness, and timeliness in compliance with GCP and protocol requirements
- Respond to data queries and collaborate with monitors and sponsors during monitoring visits
- Maintain organized and audit-ready study documentation
- Collaborate closely with infusion nurses, providers, and research leadership to coordinate study-related care
- Communicate effectively with sponsors, CROs, and monitors regarding study progress and issues
- Assist with investigational product accountability, documentation, and coordination with pharmacy or nursing staff as applicable
- Educate study participants on protocol requirements, visit expectations, and study procedures
- Serve as a primary point of contact for research participants throughout study participation
- Ensure participant safety, confidentiality, and informed consent compliance at all times
- Ensure compliance with study protocols, GCP guidelines, HIPAA regulations, and institutional policies
- Maintain confidentiality of patient and study information
- Assist with monitoring visits, audits, and inspections as required
- Identify protocol deviations and escalate concerns to research leadership
- Track study milestones including enrollment, visits, and follow-ups
- Maintain study calendars and visit schedules
- Assist with ordering and tracking study supplies and materials
- Perform assigned clerical duties including filing, scanning, copying, and data organization
- Support infusion and clinical teams with research-related coordination needs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
