IRB Specialist - Institutional Review Board at Mayo Career Site US

Rochester, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Aug, 26

Salary

101212.8

Posted On

18 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

IRB Management, Regulatory Compliance, Human Subjects Research, Analytical Skills, Organizational Skills, Time Management, Interpersonal Communication, Technical Writing, Decision Making, Problem Solving, Meeting Facilitation, Database Proficiency

Industry

Hospitals and Health Care

Description

The IRB Specialist is primarily responsible for the management of a caseload of applications submitted for IRB review and demonstrates sound judgment, as well as analytical, organizational, and time management skills. Serves as a critical link between and is an expert resource for the Mayo research community (principal investigators and other study personnel), the Mayo's Office for Human Subjects Protection, and the Mayo IRB members; is knowledgeable about the federal and state regulations governing human subject research, and related institutional policies and procedures; continuously interprets and applies these requirements to human subject research proposals and ongoing research activities; performs a detailed analysis of all applications submitted for IRB review; manages the disposition of items submitted electronically for IRB review. This includes assessments of completeness, accuracy, and level of review required. Applies strong organizational skills and effective teamwork skills to manage a large volume of submissions, deadlines, and customer expectations; completes critical and comprehensive review of submissions, seeks clarification or alteration of the submission from Mayo researchers, and makes independent determinations or presents recommendations to the convened IRB. Serves as a voting member of the convened IRB and a designated Expedited Reviewer to review and approve non-exempt minimal risk research using expedited review procedures; provides technical support and guidance on regulatory matters during convened IRB meetings; conducts expedited reviews, documents application-specific findings and generates investigator notifications regarding the outcome of the review. Exercises the authority to make not-human subjects research and exempt determinations; responsible for conducting evaluations of investigator's response to identify potential issues for IRB reviewers and advise as to whether the requirements for IRB approval have been met. In partnership with the IRB Chairs, is responsible for managing the pre-meeting, meeting and post-meeting activities of the convened IRB. This includes agenda management, and meeting facilitation and documentation. Provides guidance to IRB Administrative Assistants, in support of efficiency and effectiveness of IRB operational activities and drafts, edits and prepares correspondence and notification letters using databases. Participates in the orientation and training of IRB personnel, including peers. Assists with the orientation of new IRB members and actively participates in the training of new nonscientific IRB members and participate in IRB-related quality and educational activities as needed. 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. This is a hybrid position and must be located within 100 miles of either our Rochester, Arizona, or Florida Mayo Clinic campuses for occasional on-site expectations based on business needs. On-site expectations will be discussed during the interview process. This vacancy is not eligible for sponsorship. We will not sponsor or transfer visas for this position. Also, Mayo Clinic DOES NOT participate in the F-1 STEM OPT extension program. 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 [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. Benefits Highlights * Medical: Multiple plan options. * Dental: Delta Dental or reimbursement account for flexible coverage. * Vision: Affordable plan with national network. * Pre-Tax Savings: HSA and FSAs for eligible expenses. * Retirement: Competitive retirement package to secure your future. 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] Equal Opportunity 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.

Responsibilities

Manages a caseload of IRB applications, ensuring compliance with federal and state regulations for human subject research. Serves as a voting member of the convened IRB and coordinates pre- and post-meeting activities.