Clinical Research Coordinator - Cancer Center

Mayo Clinic•Jacksonville, FL

1d•Onsite

About The Position

This on-site position requires the candidate to live within driving distance of the Mayo Clinic Jacksonville campus. Relocation is not offered for this role. The Clinical Research Coordinator receives direction from the principal investigator, supervisor, or other staff involved in research protocol(s) and gives direction to and works cooperatively with other research staff. This role collaborates with various departments within the institution and works cooperatively with other investigators and personnel at all levels. The coordinator interacts with research participants, other research centers, and sponsoring companies to resolve problems and ensure efficient completion of research studies. The position overview includes independently coordinating complex clinical research protocols with minimal direction, assessing feasibility, ensuring implementation after IRB approval, and providing information for progress reports. Responsibilities include screening, enrolling, and recruiting participants, coordinating schedules, monitoring activities and subject participation, identifying and reporting adverse events and deviations, managing and reporting research data, and providing education/training for others. Administrative and regulatory duties related to the study are also performed. Some travel may be required. The addendum details protocol development and maintenance activities, including ongoing management of the protocol document, amendments, proofing, coordination of study logistics, verification of content, communication with study sites and federal agencies, Federal and Institutional Review Board (IRB) document preparation and submission, and providing consultative expertise. The role accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures, consistent with internal and external policies and regulatory requirements. Participation in other protocol development activities and execution of other assignments as warranted and assigned is also included. Visa sponsorship is not available for this role, and Mayo Clinic does not participate in the OPT Stem program.

Requirements

HS Diploma with at least 5 years of clinical research coordination/related experience OR Associate's degree/college Diploma/Certificate Program with at least 3 years of experience, Associate's in Clinical Research from an accredited academic institution without experience OR Bachelor's 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 the clinical setting or related experience.

Nice To Haves

Graduate or diploma from a study coordinator training program is preferred.
One year of clinical research experience is preferred.
Medical terminology course is preferred.

Responsibilities

Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines.
Collaborates with research team to assess feasibility and management of research protocols.
Ensures implementation of research protocols after IRB approval and provides information as appropriate for progress reports.
Screens, enrolls, and recruits research participants.
Coordinates schedules and monitors research activities and subject participation.
Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.
Manages, monitors, and reports research data to maintain quality and compliance.
Provides education/training for others within the department.
Performs administrative and regulatory duties related to the study as appropriate.
Ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards.
Communication with study sites and/or federal agencies regarding study status changes.
Federal and Institutional Review Board (IRB) document preparation and submission.
Provides consultative expertise regarding regulatory and policy requirements.
Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements.
Participates in other protocol development activities and executes other assignments as warranted and assigned.