Clinical Research Coordinator - Physical Medicine Rehabilitation

Mayo Clinic•Rochester, MN

About The Position

Independently coordinates complex clinical research protocols, including interventional and therapeutic protocols greater than minimal risk, with minimal direction from the principal investigator and/or supervisor. The position ensures compliance with regulatory laws and institutional guidelines and collaborates with the research team to assess protocol feasibility and management. It implements protocols after IRB approval, supports progress reporting, recruits and enrolls participants, coordinates schedules and research activities, and monitors participant involvement. The coordinator reviews and reports adverse events, protocol deviations, and other unanticipated problems, and manages research data to support quality and compliance. The role also provides departmental education and training and performs study-related administrative and regulatory duties. Some travel may be required. Protocol development and maintenance work may include managing protocol documents and processes through editing, amendments, proofing, and content verification; coordinating study logistics such as blood collection kits, data collection booklets, and use of the CRU; communicating with study sites or federal agencies about study status changes; preparing and submitting federal and institutional IRB documents; and providing consultative expertise on regulatory and policy requirements. The coordinator accurately incorporates investigators’ scientific data into protocol documents and related procedures in accordance with internal and external policies and regulatory requirements, and performs other assigned protocol development activities. This position is 0.80 FTE (64 hours per pay period, or every two weeks). Visa sponsorship is unavailable, and the position is not eligible for the F-1 OPT STEM extension.

Requirements

High school diploma with at least 5 years of clinical research coordination or related experience; or an associate’s degree/college diploma/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 that year.
Experience should 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 while complying 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 as appropriate.
Screen, recruit, and enroll 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 for others within the department.
Perform administrative and regulatory duties related to studies.
Manage protocol documents and processes, including editing, amendments, proofing, and content verification.
Coordinate study logistics, including 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 IRB documents.
Provide consultative expertise regarding regulatory and policy requirements.
Incorporate investigators’ scientific data into protocol documents and associated procedures consistent with internal and external policies and regulatory requirements.
Participate in other protocol development activities and carry out other assignments as warranted.