- 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.
- 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.
During the selection process you may participate in an OnDemand (pre-recorded) interview that you can complete at your convenience. During the OnDemand interview, a question will appear on your screen, and you will have time to consider each question before responding. You will have the opportunity to re-record your answer to each question - Mayo Clinic will only see the final recording. The complete interview will be reviewed by a Mayo Clinic staff member and you will be notified of next steps.
***Visa sponsorship is not available for this position. This position is not eligible for F-1 OPT STEM extension.***
**This position is in the Office of Clinical Trials. For more information, please visit: https://www.mayo.edu/research/centers-programs/center-clinical-translational-science/offices/office-of-clinical-trials
***This position will be working Nights and Weekends. The selected candidate will have the option to choose an FTE between 0.50 - 1.0.***
As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.
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. You'll thrive in an environment that supports innovation, is committed to ending racism and supporting diversity, equity and inclusion, and provides the resources you need to succeed.