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. Some travel may be required.
ADDENDUM (if applicable)
Protocol Development and Maintenance Activities
Responsibilities may include, but are not limited to: 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; and 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.
Bachelor's degree required. Minimum of one year of experience in a clinical research setting or related field required. Completion of Mayo Clinic competency based assessment program will be required within one year of hire.
Graduate or diploma from a study coordinator training program is preferred. SoCRA or ACRP certification preferred. Medical terminology course preferred. Strongly prefer cancer terminology and direct patient care experience, focus on multiple myeloma and chronic lymphocytic leukemia. Hematology research experience preferred; strong medical terminology preferred; direct patient care strongly preferred.
Medical terminology with direct patient care experience strongly preferred; clinical trial research experience preferred
Education, experience and tenure may be considered along with internal equity when job offers are extended. The minimum pay rate is $23.89 per hour.
Core business hours between 7:30 a.m. and 6 p.m. The work schedule is an 8 hours/day, Monday - Friday within the core business hours. Flexible depending on patient care needs.
Occasional nights or weekends
Jacksonville is the largest city in area in the continental United States. A beautiful coastal Florida city that features excellent year-round climate, over 20 miles of beaches and outstanding outdoor recreational, cultural and family-oriented amenities. The “River City by the Sea” has an excellent school system, reasonable cost of living and a thriving business environment. Medical professionals and patients are drawn to Jacksonville by an extraordinary network of high-profile healthcare facilities. Jacksonville continues to grow as more people relocate from all over the U.S. and abroad, to see what the great River City has to offer!
Clinical Labs and Research
Job posting number
Equal opportunity employer
Mayo Clinic is an equal opportunity educator and employer (including veterans and persons with disabilities).