Clinical Research Coordinator - Cancer Center
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 or supervisor. The role ensures study activities comply with regulatory laws and institutional guidelines, collaborates with the research team to assess protocol feasibility and management, and implements protocols after IRB approval. The coordinator screens, enrolls, and recruits participants; schedules and monitors study activities and participant involvement; identifies and reports adverse events, protocol deviations, and other unanticipated problems; and manages and reports research data to support quality and compliance. The role also provides education and training to departmental staff and performs administrative and regulatory duties. Protocol development and maintenance duties may include editing and amending protocol documents, proofing, coordinating study logistics, verifying content against institutional and federal standards, communicating with study sites or federal agencies about status changes, preparing and submitting federal and IRB documents, and advising on regulatory and policy requirements. The coordinator accurately incorporates investigators' scientific data into protocol documents and related procedures, participates in other protocol development activities, and completes additional assignments as needed. Some travel may be required. This position is based at the Mayo Clinic Florida site; relocation is not offered, and visa sponsorship is unavailable.
Requirements
- High school diploma with at least 5 years of clinical research coordination or related experience; OR an associate's degree, college diploma, or certificate program with at least 3 years of experience; OR an associate's degree in Clinical Research from an accredited academic institution without experience; OR a bachelor's degree with at least 1 year of experience.
- Completion of a Mayo Clinic-sponsored clinical research internship may substitute for 1 year of experience for the bachelor's degree pathway.
- Experience should be in a clinical setting or a related area.
Nice To Haves
- Graduate or diploma from a study coordinator training program.
- One year of clinical research experience.
- Medical terminology course.
Responsibilities
- Independently coordinate complex clinical research protocols with minimal direction, in compliance with regulatory laws and institutional guidelines.
- Collaborate with research teams to assess protocol feasibility and management.
- Implement research protocols following IRB approval and provide information for progress reports as appropriate.
- Screen, enroll, and recruit research participants.
- Coordinate schedules and monitor research activities and participant involvement.
- 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 to others within the department.
- Perform administrative and regulatory duties related to studies.
- Manage protocol documents and processes, including editing, amendments, proofing, and verification against institutional and federal standards.
- Coordinate study logistics, such as blood collection kits, data collection booklets, and use of the CRU.
- Communicate with study sites and/or federal agencies regarding study status changes.
- Prepare and submit federal and IRB documents.
- Provide consultative expertise regarding regulatory and policy requirements.
- Incorporate investigators' scientific data into protocol documents and associated procedures consistent with applicable policies and regulatory requirements.
- Collaborate with research staff, institutional departments, investigators, research participants, other research centers, and sponsoring companies to resolve problems and support efficient study completion.
Benefits
- Multiple medical plan options.
- Dental coverage through Delta Dental or a reimbursement account for flexible coverage.
- Vision plan with a national network.
- Health Savings Account and Flexible Spending Accounts for eligible expenses.
- Competitive retirement package.
- Continuing education and advancement opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
