Job Description

Summary The Institutional Review Board (IRB) Administrator is responsible for supporting the Baptist Health Sciences University (BHSU) human subjects research (HSR) program and BHSU IRB.The Administrator will support the initial implementation of the BHSU IRB and IRB management platform(s), preview and review research proposals and protocol submissions, make recommendations to the IRB chair and full board, support IRB meetings and general IRB functions, and maintain records and IRB rosters and minutes. The IRB administrator will also aid in the function of the Office of Research through continuous internal quality improvement and education. This position will report directly to the Associate Dean of Research, responsible for 8 hours/day, 5 days/week. Incumbents may occasionally be subject to hours beyond the normal workday. Responsibilities 1.Work with the BHSU Director of Sponsored programs and Associate Dean for Research to develop and implement and edit current written IRB processes and workflows, including working with OneAegis to implement the electronic IRB management system 2.Preview and review submissions to the BHSU IRB for completeness, inaccuracies, and compliance and make recommendations to/advise the BHSU IRB chair 3.Maintains institutional HSR policy and compliance with current Federal HSR guidelines and makes recommendations for policy/procedure edits as Federal guidelines evolve 4.Draft and manage IRB alliance and reliance workflows, procedures, and agreements, particularly for IRB reliance involving BHSU-BCRI collaborative research falling under clinical trials, hospital system(s), or falling under FWA 5.Performs related accountabilities/responsibilities as required or directed 1.Work with the BHSU Director of Sponsored programs and Associate Dean for Research to develop and implement written IRB processes and workflows, including working with OneAegis to implement the electronic IRB management system. Main Activities Knowledge/Skills 1.Review current Baptist Memorial Health Care Corporation (BMHCC) system HSR and IRB policies and recommend edits and/or updates for use by BHSU IRB 2.Develops procedures to support IRB function and HSR compliance with Federal regulations. 3.Works with multiple individuals and IRB management platform implementation team to ensure timely and organized workflows and timely "go live" date 4.Maintains IRB workflow during management system implementation and upstart 1.Knowledge of general IRB procedures and workflows 2.Ability to communicate and distill complex regulatory language and workflows 3.Communication skills 4.Excellent computer, database, and information management skills Preview and review submissions to the BHSU IRB for completeness, inaccuracies, and compliance and make recommendations to/advise the BHSU IRB chair. Main Activities Knowledge/Skills Processes and maintains confidential data. Coordinates HSR principal investigators and administration and contract/grants personnel. Provides guidance to principle investigators regarding BHSU extramural grant submission processes and procedures Ability to coordinate complex budgets including subaward, consortia, and multi-institutional awards Ability to coordinate and communicate with BHSU senior administration, BUCOM research administration, principle investigators and other BMHCC personnel as applicable. Maintains institutional HSR policy and compliance with current Federal HSR guidelines and makes recommendations for policy/procedure edits as Federal guidelines evolve. Main Activities Knowledge/Skills Monitors institutional compliance with Federal HSR and IRB guidelines Maintains appropriate records Maintains and updates BHSU HSR or IRB registrations with applicable compliance agencies at the state and federal levels General knowledge of laws, regulations, and policies relating to the protection of human subjects and conflict of interest, and other HSR compliance related activities. Excellent record-keeping skills 4.Draft and manage IRB alliance and reliance workflows, procedures, and agreements, particularly for IRB reliance involving BHSU-BCRI collaborative research falling under clinical trials, hospital system(s), or falling under FWA Main Activities Knowledge/Skills 1.Communicate with appropriate administrative and research personnel to adopt best practices between multiple organizations for the protection of human subjects and vulnerable populations 2.Attend appropriate meetings, webinars, conferences to maintain close collaborative ties with BCRI, BMHCC, and other potential collaborators 1.Communication skills 2.Excellent writing skills 3.Knowledge of Federal and state guidelines regarding HSR and IRB reliance/affiliation, or other similar agreements 5.Performs related accountabilities/responsibilities as required or directed. Requirements, Preferences and Experience Minimum Qualifications Knowledge/Education Experience Bachelor's degree At least five (5) years of experience in human subjects research (HSR) compliance, HSR or IRB administration or equivalent Desired Qualifications Knowledge/Education Experience Licensure, Registration, Certification Master's degree in research administration or research compliance preferred. Seven (7) years of research administration experience or equivalent. Experience in IRB policies and procedures or IRB coordination/administration Broad experience in research administration/procedures (and strong interpersonal and communication skills.) Certified IRB Professional or equivalent credentials desired Obtaining CIP® within 18 months of eligibility to take the exam is expected. About Baptist Memorial Health Care At Baptist, we owe our success to our colleagues, who have both technical expertise and a compassionate attitude. Every day they carry out Christ's three-fold ministry-healing, preaching and teaching. And, we reward their efforts with compensation and benefits packages that are highly competitive in the Mid-South health care community. For two consecutive years, Baptist has won a Best in Benefits award for offering the best benefit plans compared with their peer groups. Winners are chosen based on plan designs, premiums and the results of a Benefits Benchmarking Survey. At Baptist, We Offer: Competitive salaries Paid vacation/time off Continuing education opportunities Generous retirement plan Health insurance, including dental and vision Sick leave Service awards Free parking Short-term disability Life insurance Health care and dependent care spending accounts Education assistance/continuing education Employee referral program Job Summary: Position: 19796 - Administrator-IRB Facility: Baptist Health Sciences University Department: CS Medical Education - Admin University Category: Academics Type: Non Clinical Work Type: Full Time Work Schedule: Days Location: US:TN:Memphis Located in the Memphis metro area REQNUMBER: 23350

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