Clinical Research Coordinator - Cancer Center

Mayo Clinic • Jacksonville, FL

7h • $28 - $42

About The Position

The Clinical Research Coordinator independently coordinates complex clinical research protocols, including interventional and therapeutic studies involving greater than minimal risk, with minimal direction from the principal investigator and/or supervisor. The role ensures research is conducted in 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; screens, recruits, and enrolls participants; schedules and monitors study activities and participant involvement; and identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems. The role manages and monitors research data to maintain quality and compliance, trains and educates department staff, and performs administrative and regulatory duties related to studies. Some travel may be required.

Protocol development and maintenance duties may include managing protocol documents and processes through editing, amendments, proofing, and coordination of study logistics; 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 advising on regulatory and policy requirements. The coordinator applies investigators’ scientific data to protocol documents and related procedures in a format consistent with internal and external policies and regulatory requirements, and performs other protocol development activities and assignments as needed.

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; or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience.
• Experience should be in a clinical setting or a related area.
• Ability to coordinate complex clinical research protocols in compliance with regulatory laws and institutional guidelines.
• Licensure or certification is not required.

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 from the principal investigator and/or supervisor.
• Collaborate with the research team to assess protocol feasibility and management.
• Implement research protocols after IRB approval and provide information for progress reports as appropriate.
• Screen, recruit, and enroll research participants.
• Coordinate schedules and monitor research activities and participant involvement.
• Identify, review, and 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 of content 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 Institutional Review Board documents.
• Provide consultative expertise regarding regulatory and policy requirements.
• Apply investigators’ scientific data to protocol documents and associated procedures in accordance with internal and external policies and regulatory requirements.
• Work cooperatively with research staff, institutional departments, investigators, research participants, other research centers, and sponsoring companies to resolve problems and complete studies efficiently.
• Perform other protocol development activities and assignments as warranted and assigned.

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.
• Competitive compensation and comprehensive benefit plans.
• Continuing education and advancement opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree