- Manage the day-to-day operations of the HRPP office, ensuring quality, efficiency and compliance with international, federal, state, and university regulations and ethical principles.
- Provide leadership and direction to the Post Approval Monitoring and Education teams, ensuring quality and timely completion of monitoring activities and educational initiatives.
- Oversee the distribution and analysis of the annual satisfaction survey to gather feedback from stakeholders and improve program effectiveness.
- Lead the operational activities of the IRB, including maintaining AAHRPP accreditation standards for approval time and compliance which include annual reporting and reaccreditation.
- Ensure the facilitation of weekly IRB meetings and ensure timely reporting to federal agencies and institutional leadership of all New Reportable Information (NRI) within 30 days of identification.
Policy and Guidance: - Supervise the Policy and Guidance team within the HRPP, responsible for developing, refining, and implementing guidance documents, policies, and procedures to promote compliance with regulations and ethical conduct of human research protection.
- Ensure effective management of noncompliance issues and facilitate communication with principal investigators and research teams regarding corrective actions.
- Bachelor's degree in a relevant field (, public health, regulatory affairs, biomedical ethics) required
- Minimum of 2-3 years of experience leading a human research protections program office or managing a human research protections program team.
- Minimum of 7-10 years of overall experience in human research protections.
- Demonstrated experience working in and fostering a diverse faculty, staff, and student environment, or a commitment to doing so as a staff member at VCU.
- Strong ability to proactively mitigate problems prior to escalation.
- Excellent communication skills, change management acumen, and demonstrated ability to collaborate effectively within teams.
- Commitment to transparency and shared governance across ethics review groups.
- Master's degree in a relevant field (, public health, regulatory affairs, biomedical ethics) preferred.
- Certification as an Institutional Review Board (IRB) Professional (CIP) or Certified Compliance Professional (CCP) is preferred.
- Minimum of 10 years of experience in human research protection or a related field, with demonstrated leadership and management capabilities, including experience managing complex teams.
- In-depth knowledge of federal and state regulations governing human subjects research protections (, Common Rule, FDA regulations).
- Strong communication, interpersonal, and organizational skills, with the ability to collaborate effectively with diverse stakeholders.
- Experience withAAHRPP accreditation and quality improvement initiatives preferred.
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Commonwealth of Virginia Richmond, United StatesWelcome to Virginia Commonwealth University (VCU) ... a world unlike any other · At VCU we combine learning, research, creativity, service and discovery with a commitment to inclusive excellence. Ranked by U.S. News as one of the 30 "most innovative" public universities in the ...
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Deputy Director, Human Research Protection Program - Richmond, United States - Virginia Commonwealth University
Description
Welcometo Virginia Commonwealth University (VCU) ... a world unlike any other
At VCU we combine learning, research, creativity, service and discovery with acommitment to inclusive excellence. Ranked by News as one of the 30 "mostinnovative" public universities in the country, VCU is a premier, urban, publicresearch university home to multiple nationally ranked programs.
VCU's Office of the Vice President for Research and Innovation's (OVPRI)mission is to foster transformative research, discovery and innovation at VirginiaCommonwealth University through excellence in service.
Through our passion for discovery and willingness to take on challenges, wecontinue to advance the work that matters most and position the university as anational leader in research, innovation, creativity and scholarship. Ourcommitment has resulted in record levels of sponsored research and has placedVCU among the nation's premier public research universities. OVPRI link
The OVPRI and our Human Research Protection Program (HRPP) invites allinterested candidates to apply for an exciting opportunity as the new DeputyDirector (Job Family - Legal, Audit & Compliance, Job Title – Deputy DirectorLG, Job Code
Position Overview:
The Deputy Director of the Human Research Protection Program (HRPP) office at VCU will lead the operations of the HRPP office, including oversight of post-approval monitoring, education, policies and procedures, and IRB operations. This role reports to the HRPP Director and is within the Office of the Vice President for Research and Innovation.
Key Responsibilities:
HRPP Operational Oversight:
HRPP Transformation:
Transformation initiatives include efforts to enhance the efficiency, effectiveness, and compliance of the HRPP, with a primary focus on on-boarding a new electronic Institutional Review Board (IRB) system. Responsibilities include collaborating with stakeholders to assess needs and requirements, developing comprehensive training programs, overseeing data migration, and proactively addressing implementation challenges. This role requires strong leadership, change management, and project management skills, as well as experience in human subjects protection.
Collaboration and Liaison:
The Associate/Deputy Director will serve as a liaison with other research support units, fostering collaboration with peer review research ethics boards/committees including, the Conflict of Interest Committee, the FDA Program Officer, the Radiation Safety Committee, and the Biosafety Committee. In addition, the Associate Director may be called upon to represent VCU's HRPP in interactions with regulatory agencies, accrediting bodies, and funding agencies, maintaining strong relationships and ensuring compliance with requirements.
Minimum Hiring Standards:
Preferred Hiring Standards:
Additional Employment Information
All full-time university staff are eligible for our generous benefits packagethat includes choices for health, vision and dental coverage, life-insurance,short and long-term disability coverage, retirement planning, tax-deferredannuity and cash match programs, flexible spending accounts, tuition benefits,significant paid-time off, 12 paid holidays and more.
Explore our robust benefit package here:
In a world of the common, we are the UNCOMMON and UNSTOPPABLE. It's innovation at work. VCU is nationally recognized as one of the bestemployers for diversity, a place of opportunity where your success is supportedand your career can thrive, and more than 300,000 strong.
Salary Range: Commensurate with experience to $159,600
Position Details:
Department: Office of the Vice President for Research & Innovation and Human Research
Protection Program Office
Job Information: Job Family - Legal, Audit & Compliance, Job Title - Deputy Director LG,
Job Code
Employment Type: UF - University Employee FT
Restricted Status: Yes
FTE:
ORP Eligible: Yes
Exemption Status: Exempt
