Associate Clinical Research Coordinator - Comprehensive Cancer Center

Mayo Clinic•Rochester, MN

About The Position

Coordinates non-therapeutic clinical research protocols, such as minimal-risk, survey, and chart-review studies, under the direction of the principal investigator and/or supervisor and in compliance with regulatory laws and institutional guidelines. May assist with complex interventional, therapeutic, or greater-than-minimal-risk studies under direction, but does not have overall responsibility for those studies. Screens, enrolls, and recruits participants; coordinates schedules; monitors research activities and participant involvement; recognizes and appropriately reports adverse events, protocol deviations, and other unanticipated problems; collects, abstracts, and enters research data; and performs assigned administrative and regulatory duties. Some travel may be required. Protocol development and maintenance duties may include managing protocol documents and processes through editing, amendments, proofing, and verification that content meets institutional and federal standards; coordinating study logistics, such as data collection booklets and use of the CRU; submitting materials to the Institutional Review Board (IRB); and communicating with study sites and/or federal agencies about study status changes. The role also participates in other protocol-development activities and performs other assignments as warranted and assigned.

Requirements

High school diploma with at least 3 years of experience; or an associate's degree, college diploma, or certificate program with at least 1 year of experience; or an associate's degree in Clinical Research from an accredited academic institution with no experience; or a bachelor's degree.
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 non-therapeutic clinical research protocols under the direction of the principal investigator and/or supervisor, in compliance with regulatory laws and institutional guidelines.
Assist with complex interventional, therapeutic, or greater-than-minimal-risk studies under direction, without overall responsibility for those studies.
Screen, enroll, and recruit research participants.
Coordinate schedules and monitor research activities and participant involvement.
Recognize and appropriately report adverse events, protocol deviations, and other unanticipated problems.
Collect, abstract, and enter research data.
Perform assigned administrative and regulatory duties related to studies.
Manage protocol documents and processes, including editing, amendments, proofing, and verifying content against institutional and federal standards.
Coordinate study logistics, including data collection booklets and use of the CRU.
Prepare and submit materials to the Institutional Review Board (IRB).
Communicate with study sites and/or federal agencies regarding study status changes.
Participate in other protocol-development activities and perform other assignments as warranted and assigned.
Travel as required.