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Experience
5-7 yrs required
Location
Philadelphia, PA, United States
Posted on
May 30, 2020
Profile
Director for Human Research Protections
Duties: Reporting to the Vice Provost for Research (VPR), the Director of Human Research Protection Program collaboratively develops strategy and develops and implements University policy and procedures as they pertain to the University’ s Human Research Protection Program which includes 9 IRBs, and ensures compliance with all federal and state statutes and regulations on the protection of human subjects participating in research conducted within the 12 Schools of the University and the 5 hospitals that make up Medicine. Act as advisor to the Vice Provost for Research and other senior University officials on human research regulations, ethics, and compliance; Represent Penn’s Human Research Protection Programs at national and local meetings and serve on multiple University committees and lead HRPP initiatives; Serve as spokesperson for the University on ethical and regulatory issues; Lead the development of institutional policies and procedures for the protection of human research participants. Collaborate with other members of the VPR leadership team and other University offices to implement, improve and harmonize human research policies across all units; Provide leadership in identifying educational and training needs for IRB constituents to include faculty and staff across the University. Maintain AAHRPP accreditation; Manage the IRB budget; Supervise staff, including hiring, performance evaluation, and management; Supervise regulatory and ethical review of over 6500 protocols; implement innovative approaches to process optimization; Serve as a voting member of IRBs with signature authority for IRB related actions; Provide oversight of hiring, evaluation, and discipline of IRB administrative staff; establish work priorities and deadlines. Direct administrative functions of the IRBs. Develop and maintain IRB policies, procedures and accompanying manuals. Monitor federal changes in regulations and federal guidance or interpretation of regulations. Develop, maintain and administers policies for the University that impact the human research protection program. Act as advisor to the Vice Provost for Research and other university officials on human research regulations, ethics, and compliance. Serve as regular, voting member of select **MEMBERS ONLY**SIGN UP NOW***. IRBs with signature authority for IRB-related issues Represent the HRPP through membership on committees. Represents the University at national and local meetings. Fulfill the responsibilities of the Human Research Protections administrator/point of contact for the University s federal wide assurance of compliance. Draft reports to federal agencies of serious or continuing noncompliance with regulations; unanticipated events posing risks to subjects or others; and terminations or suspensions of IRB approval, and uphold HRP requirements across multiple hospitals. Maintain AAHRPP accreditation. Ensure consistent application of accreditation standards within the HRPP and across the University. Guide faculty and staff through the re-accreditation process; prepare and submit annual reports, re-accreditation applications, and other mandatory reports to AAHRPP. Works closely with Senior Associate Vice Provost for Human Research to recruit IRB chairs. Supervises the development and implementation of IRB member and chair training. In collaboration with the ISC, and maintain the IRB electronic submission process Assess IRB resource requirements. Prepare projections of budgetary needs for approval. Oversee and maintain the IRB budget.
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