Mayo Clinic·Jacksonville, Florida
Independently coordinates complex clinical research protocols in compliance with regulatory laws and institutional guidelines. Responsibilities include screening and enrolling participants, monitoring research activities, and managing protocol documentation and IRB submissions.
Receives direction from principal investigator, supervisor, or other staff involved in research protocol(s).
Gives direction to and works cooperatively with other research staff.
Collaborates with various departments within the institution.
Works cooperatively with other investigators and personnel at all levels.
Interacts with research participants, other research centers, and sponsoring companies to resolve problems and ensure efficient completion of research studies.
Position Overview: (Major Functions and Non-Essential Functions): 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.
Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans [https://jobs.mayoclinic.org/benefits/] – to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic.
Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. [https://jobs.mayoclinic.org/alllocations]
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status or disability status. Learn more about the "EOE is the Law" [https://www.eeoc.gov/poster]. Mayo Clinic participates in E-Verify [https://www.e-verify.gov/sites/default/files/everify/posters/EVerifyParticipationPoster.pdf] and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization.
Requires a high school diploma with 5 years of experience, an associate degree with 3 years, or a bachelor's degree with 1 year of clinical research experience. Preferred qualifications include a study coordinator training program certificate and a medical terminology course.
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