Clinical Research Coordinator - Alzheimer's Disease Research

Mayo Clinic•Rochester, MN

About The Position

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 and in compliance with regulatory laws and institutional guidelines. Collaborates with the research team to assess protocol feasibility and management; implements protocols after IRB approval; and provides information for progress reports as appropriate. Screens, enrolls, and recruits participants, coordinates schedules, monitors research activities and participant involvement, and identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems. Manages, monitors, and reports research data to maintain quality and compliance. Provides departmental education and training and performs administrative and regulatory study duties as appropriate. Some travel may be required. Protocol development and maintenance activities may include managing protocol documents and processes through editing, amendments, and proofing; coordinating study logistics such as blood collection kits, data collection booklets, and use of the CRU; verifying that content meets institutional and federal standards; communicating with study sites and/or 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 cohesive protocol documents and associated procedures that comply with internal and external policies and regulatory requirements. Other protocol development activities and assignments may be performed as warranted. Cognitive testing is a required responsibility. Prior experience is not necessary, but the coordinator should be comfortable learning to administer standardized cognitive assessments. 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 degree, college diploma, or certificate program with 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 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 be related experience.
Strong clinical trial background, including experience with clinical trial coordination and study conduct.
Comfort learning to administer standardized cognitive assessments.
Some travel may be required.

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 and in compliance with regulatory and institutional requirements.
Collaborate with the research team to assess protocol feasibility and management.
Implement research protocols following IRB approval and provide information for progress reports.
Screen, enroll, and recruit 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, logistics coordination, and verification of content against 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.
Accurately incorporate investigators’ scientific data into protocol documents and associated procedures consistent with applicable policies and regulatory requirements.
Administer standardized cognitive assessments after training.
Perform other protocol development activities and assignments as warranted.
Travel as required.