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The Director, Human ResearchProtection Program (HRPP) is amanagement position within theDrexel University Office ofResearch.
The Director supports the Drexel research community in the conduct of innovative and ethical research by providing guidance, education and oversight for the protection of human subjects.
Serving as the University’s expert on research involving human subjects from an operational, regulatory and strategic point of view
Managing HRPP staff that support all aspects of research involving human subjects
Communicating regularly with the research community
Acting as the primary liaison with federal and state agencies on human research issues
Providing oversight for the ongoing work of the Institutional Review Boards on Human Research (IRB) including administrative operations, providing orientation and continuing education to IRB members and implementation of policies and procedures of the Institution’s three Boards
Overseeing IRB documents of record to ensure appropriate documentation and maintenance of IRB actions and correspondence related to IRB submissions, approvals and termination of IRB activities
Utilizing IRB data to provide strategic insight into the human subjects research at the University; preparing and submitting regular narrative reports related to IRB and human subjects research activities to Drexel leadership
Advising investigators, students, and senior administrators on federal regulations and institutional policies and procedures to ensure institutional compliance with the ethical and regulatory requirements for human subject’s research
Serving as front-line resource to investigators wanting to conduct research involving human subjects including supporting investigators through the IRB submission process and providing counsel on human subject protections and research quality
Organizing regular meetings of the HRPP leadership group, develops meeting agenda and materials, takes and distributes minutes
Gathering input on HRPP policies, drafts revisions, brings revisions to the HRPP leadership group for approval, and makes updates to the posted HRPP policy manual
Managing AAHRPP accreditation
Creation of annual reports and required status reports for AAHRPP accreditation
Maintain AAHRPP accreditation status and reporting requirements, and Drexel HRPP program revisions
Leads the AAHRPP re-accreditation application and site visit processes
Managing the training and education activities of the human subject protection program; tracks certification of research personnel.
Reporting on monitoring, training and education, and conflict of interest disclosure to the IRB and/or the Research Compliance Committee as required.
Consulting with federal agency staff, as necessary, regarding the interpretation and implementation of guidelines
Interpreting and applying federal, state and local regulations, policies and procedures related to human subject research
Serving as steward of Drexel’s federal wide assurance (FWA)
Maintaining institutional assurances, registration and approvals needed for human research
Assigning individual protocols to HRPP staff for additional regulatory compliance review
Collaborating with Quality Assurance / Quality Improvement team on all matters
Collaborating with Research Integrity on all compliance matters
Understanding the impact of any proposed regulatory changes on institutional policies pertaining to human subject research
Collaborating with Administrative Units including but not limited to pre-award, research integrity, compliance, OCG, IRB and department chairs, principal investigators, research staff and students regarding how guidelines should be implemented
Developing and presenting educational programs and workshops for IRB members, faculty and staff on the protection of human research subjects
Maintaining and growing professional knowledge and skills by attending seminars, workshops and review of published literature
Providing regular updates to the HRPP and the Office of Research web pages
RequiresBachelor ofScience degreefrom anaccreditedcollege oruniversity inhealth or biologicalsciences with 10 years of experience. Degree requirements may be substituted with an equivalent combination of education, training and experience or as aninvestigator orresearch teammemberconductingand/oroverseeinghuman subject research projects.
Prior experience conducting audits and investigations in a research setting
Prior experience developing and implementing training and education (adult education) initiatives in a research setting
Ability to handle competing priorities in a fast paced environment
Demonstrated and outstanding written and spoken communication skills
Demonstrated and outstanding ability at working with non-cohesive groups and audiences to specific ends
Experience with quality assurance / quality improvement processes or formal process improvement
Master's degreein the healthsciences preferred. CIP(Certified IRBProfessional)or CIM(Certified IRBManager)certification orable to obtainsuch within oneyear of employment.
In depth understanding of laws, rules, and regulations governing human subject research including HIPAAregulations and Good Clinical Practice. Strong understanding of Association of the Accreditation of Human Research Protection Programs (AAHRPP) accreditation and reporting requirements. Workingknowledge andunderstanding ofBiosafety policies and procedurespreferred. Excellent organizational and project management skills. Ability to work collaboratively with a diverse set of stakeholders and build effective interdisciplinary teams. Excellent interpersonal and communication skills with the ability to develop and maintain effective working relationships with various constituencies, including faculty, students, senior administrators, members of the IRBs, clinical staff, and HRPP staff. Excellent critical thinking, writing and editing abilities especially with making data driven decisions. Ability to develop and implement new policies and procedures, training and outreach. Very strong knowledge of enterprise research systems, databases, report generation. Demonstrated ability to take initiative, identify, prioritize and plan activities necessary to meet goals.
Internal Number: position#155105-req# 8897
About Drexel University Office of Research
Drexel is a comprehensive global research university ranked among the top 100 in the nation. With over 24,000 students, Drexel is one of America's 15 largest private universities.
Drexel has built its global reputation on core achievements that include:
-Leadership in experiential learning through Drexel Co-op.
-A history of academic technology firsts.
-Recognition as a model of best practices in translational, use-inspired research.
Founded in 1891 in Philadelphia, Drexel now engages with students and communities around the world via:
-Three Philadelphia campuses and other regional sites.
-The Academy of Natural Sciences of Drexel University, the nation’s oldest major natural science museum and research organization.
-International research partnerships including China and Israel.
-Drexel Online, one of the oldest and most successful providers of online degree programs.
Drexel is one of Philadelphia's top 10 private employers, and a major engine for economic development in the region. Drexel has committed to being the nation’s most civically engaged university, with community partnerships integrated into every aspect of service and academics.
Drexel’s ongoing s...trategic plan, "Transforming the Modern Urban University," guides the University's 21st-century trajectory. Learn more at the Strategic Plan website.