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. 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.

Responsibilities

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.

Additional Information:

Mayo Clinic is seeking experienced IRB professionals to facilitate excellence in human research and the protection of research participants. The primary mission of the Mayo Clinic IRB is to ensure the protection of rights, privacy and welfare of all human participants in research programs conducted by Mayo Clinic and associated faculty, professional staff and students. Coexistent with participant protection is the goal of providing quality service to enhance the conduct of research.

Relevant to at least one of the current openings, recruitment is dedicated to addressing an upcoming need for an IRB specialist with sIRB/reliance focus.

Candidates having substantive experience with either of the following will be considered with preference:

1) single IRB (sIRB) review (when mandated) for multi-center research, or

2) direct experience within Mayo Clinic IRB operations and all related policies, procedures, and practices.

The IRB Specialist with sIRB/reliance focus will support Mayo Clinic’s growing human research portfolio by providing dedicated support to researchers who engage in collaborative research. Mayo Clinic participates as both a Relying Organization and Reviewing IRB under the sIRB model. The individual will facilitate efficient and compliant sIRB/reliance activities, a key component of Mayo Clinic’s Human Research Protection Program (HRPP) and the IRB Office.

This position offers a variety of duties but is primarily responsible for leading the reliance process and negotiating relationships between Mayo Clinic IRB and outside/external Reviewing IRBs, including institutional and commercial IRBs, as well as external Reyling Organizations.

The position advises researchers about general reliance questions, and single IRB options on a study-specific specific basis. The role coordinates developing of communication plans, setting up reliance documentation, communicating with and troubleshooting with external organizations and IRBs to complete reliance arrangements, and collaborating with the Mayo Clinic HRPP and IRB Leadership teams to develop and implement institutional requirement/strategies to ensure compliance with Mayo Clinic policy, state law, federal requirements, and accreditation standards beyond IRB review.

Qualifications

Bachelor's degree required, preferably in the natural and social sciences, nursing, management or other health-related profession and at least 2 years experience in human subjects research. Alternately, applicants with an Associate's degree and 6 years of experience in human subjects research may be considered. Ability to efficiently manage a large volume of items while maintaining a high degree of accuracy and attention to detail; strong organization and decision making skills, the ability to judge and critique multiple issues, and the analytical skills necessary to apply knowledge of federal regulations and institutional policy to variety of complex situations and research protocols; strong interpersonal skills are needed to interact with a wide variety of persons related to human subject research. Ability to communicate with team members and others in a positive and effective manner; use effective communication skills to facilitate convened IRB meetings; written communication skills in writing detailed, clear, precise and grammatically correct letters, minutes, correspondence, and reports; is dependable, self-directed, and willing to take the initiative for organizing own work to meet deadlines; ability to effectively analyze and solve problems; ability to work independently and as a member of a team. Self-motivated to function independently in a high intensity environment often driven by deadlines. Know when to refer issues to Supervisor and have the ability to make accurate and appropriate independent judgments, but be able to accept direct supervision. Ability to meet production within established time and quality standards is required; be proficient in the use of multimedia hardware and software applications, including use of Windows, database, spreadsheets and word processing.

Exemption Status

Exempt

Compensation Detail

$64,500.80 - $96,824.00 / yr

Benefits Eligible

Yes

Schedule

Full Time

Hours/Pay Period

80

Schedule Details

Monday-Friday (Standard business hours, with the ability to meet the needs of research)

Weekend Schedule

N/A

International Assignment

No

Site Description

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)

Affirmative Action and Equal Opportunity Employer

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.

Recruiter

Matt Burdick

Equal opportunity

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.