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.
(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.
Please note that this position is not eligible for visa sponsorship. Mayo Clinic does not participate in OPT stem program.
Minimum Education and/or Experience Required: (Education Requirements and Experience):
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.
Additional Experience and/or Qualifications: (Has Achieved Competency in the Following Areas, Job Knowledge and Additional Considerations):
Graduate or diploma from a study coordinator training program is preferred. One year of clinical research experience is preferred. Medical terminology course is preferred.
Licensure/Certification Required:
N/A
Why Mayo Clinic
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 – 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.
Benefits Highlights
Mayo Clinic has expanded and changed in many ways, but our values remain true to the vision of our founders. Our primary value – The needs of the patient come first – guides our plans and decisions as we create the future of health care. Join us and you'll find a culture of teamwork, professionalism and mutual respect, and most importantly, a life-changing career.
Mayo Clinic was founded in Rochester, Minnesota by brothers Dr. William James Mayo and Dr. Charles Horace Mayo. More than 100 years later, their vision continues to evolve around a single guiding value: "The needs of the patient come first." Today we are the largest integrated, not for-profit medical group practice in the world.
We are recognized for high-quality patient care more than any other academic medical center in the nation. These endorsements are very gratifying, but also humbling. They remind us of the tradition that has been entrusted to each one of us, and the legacy of excellence that we uphold every day.
