Clinical Research Coordinator - Physical Medicine Rehabilitation
About The Position
The Clinical Research Coordinator independently coordinates complex clinical research protocols, including interventional and therapeutic studies greater than minimal risk, with minimal direction from the principal investigator and/or supervisor. The role ensures compliance with regulatory laws and institutional guidelines and collaborates with the research team to assess protocol feasibility and management. The coordinator implements protocols after IRB approval, provides information for progress reports, screens and recruits participants, manages enrollment and scheduling, and monitors study activities and participant involvement. The role reviews and reports adverse events, protocol deviations, and other unanticipated problems; manages and reports research data to maintain quality and compliance; provides departmental education and training; and performs administrative and regulatory study duties. Some travel may be required. Protocol development and maintenance work may include managing protocol documents and processes through editing, amendments, proofing, and study-logistics coordination; verifying content against institutional and federal standards; communicating with study sites and federal agencies about study status changes; preparing and submitting federal and IRB documents; and providing consultative expertise on regulatory and policy requirements. The coordinator accurately incorporates investigators’ scientific data into protocol documents and related procedures consistent with internal and external policies and regulatory requirements, and performs other protocol development activities and assigned duties. This position is 0.80 FTE, or 64 hours per pay period (every two weeks).
Requirements
- High school diploma and at least 5 years of clinical research coordination or related experience; or an associate degree, college diploma, or certificate program and at least 3 years of experience; or an associate degree in Clinical Research from an accredited academic institution without experience; or a bachelor’s degree and at least 1 year of experience, or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience.
- Experience must be in a clinical setting or related experience.
Nice To Haves
- Graduate or diploma from a study coordinator training program.
- One year of clinical research experience.
- Medical terminology course.
Responsibilities
- Coordinate complex clinical research protocols with minimal direction, ensuring compliance with regulatory laws and institutional guidelines.
- Collaborate with the research team to assess protocol feasibility and management.
- Implement research protocols after IRB approval and provide information for progress reports.
- Screen, recruit, and enroll research participants.
- Coordinate schedules and monitor research activities and participant participation.
- Identify, review, and appropriately report adverse events, protocol deviations, and other unanticipated problems.
- Manage, monitor, and report research data to maintain quality and compliance.
- Provide education and training for others in the department.
- Perform administrative and regulatory duties related to studies.
- Manage protocol documents and processes, including editing, amendments, proofing, and coordination of study logistics.
- Verify protocol content meets institutional and federal standards.
- Communicate with study sites and/or federal agencies regarding study status changes.
- Prepare and submit federal and Institutional Review Board documents.
- Provide consultative expertise regarding regulatory and policy requirements.
- Apply investigators’ scientific data accurately to protocol documents and associated procedures in accordance with internal and external policies and regulatory requirements.
- Participate in other protocol development activities and perform other assigned duties.
- Travel as required.
Benefits
- Multiple medical plan options.
- Dental coverage through Delta Dental or a reimbursement account for flexible coverage.
- Affordable vision plan with a national network.
- HSA and FSAs for eligible expenses.
- Competitive retirement package.
- Continuing education and advancement opportunities.
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What This Job Offers
Job Type
Part-time
Career Level
Mid Level
Education Level
High school or GED
