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.
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.
Additional Qualifications: 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.
Benefit Eligible: Yes Exemption Status: Exempt Compensation Detail: Education, experience and tenure may be considered along with internal equity when job offers are extended. The minimum salary every 2 weeks is approx $2,128.80, based on a full-time position. Hours/Pay Period: 80
Recruiter: Chad Musolf
Why Mayo Clinic? Mayo Clinic provides the highest quality patient care by placing the needs of the patient first. We are the largest integrated, not-for-profit medical group practice in the world with approximately 60,000 employees working in a unique environment that brings together the best in patient care, groundbreaking research and innovative medical education. We offer a highly competitive compensation package, which includes exceptional benefits, and have been recognized by FORTUNE magazine as one of the top 100 "Best Companies to Work For".
Site Description: Mayo Clinic is located in the heart of downtown Rochester, Minnesota, a vibrant, friendly city that provides a highly livable environment for more than 34,000 Mayo staff and students. The city is consistently ranked among the best places to live in the United States because of its affordable cost of living, healthy lifestyle, excellent school systems and exceptionally high quality of life.
Mayo Clinic is an equal opportunity educator and employer (including veterans and persons with disabilities).
Job Posting Category: Research Job Posting Number: 79377BR
Mayo Clinic is a not-for-profit worldwide leader in patient care, research and education. Working collaboratively and driven by patient needs, more than 55,000 dedicated professionals — across six states and in every medical and surgical specialty — provide solutions and hope to people from all walks of lifeWorking at Mayo Clinic is making a difference. It's providing the highest quality patient c...are by placing the needs of patients first. At Mayo Clinic, you'll discover a culture of teamwork, professionalism and mutual respect — and most importantly, a life-changing career.