DIRECTOR, REGULATORY OVERSIGHT
Company: The George Washington University
Location: Washington
Posted on: November 16, 2024
Job Description:
Job OverviewThe Director, Regulatory Oversight position reports
to the Associate Provost Research Integrity and Compliance (AP-RIC)
and is responsible for leading the administrative, regulatory, and
programmatic activities supporting the university's Human Research
Protection Program (HRPP), animal care and use program, and
oversight committees for the use of recombinant DNA and
biohazardous materials, and research involving human embryonic
and/or pluripotent stem cells. The Director is also responsible for
administrative oversight of the research radiation and laser safety
programs.
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The Director, Regulatory Oversight works closely with Office of
Research Integrity and Compliance leadership, the Office of
Clinical Research (OCR) staff, Environmental Health and Safety,
Office of General Counsel, regulatory committee Chairs and members,
the Attending Veterinarian, and others in the GW research community
to ensure operational efficiency and compliance with laws,
regulations, standards, and institutional requirements that impact
the research enterprise.Responsibilities
- Provides strategic leadership and operational direction to the
Office of Human Research (OHR) and Office of Research Safety (ORS)
teams;
- Oversees the administrative, regulatory, and programmatic
activities of the Institutional Review Boards (IRB); Institutional
Animal Care and Use Committee (IACUC), Institutional Biosafety
Committee (IBC), Radiation Safety Committee (RSC), Stem Cell
Research Oversight Committee (SCRO), and Laser safety program;
- Serves as Human Protections Administrator (HPA) on GW's Federal
Wide Assurance (FWA);
- Ensures a thorough review of research protocols prior to
submission to the regulatory committees for review;
- Facilitates maintenance of AAALAC accreditation; supports and
oversees AAHRPP accreditation;
- Directs semi-annual facility inspections and program
reviews;
- Communicates with federal and accrediting oversight authorities
and carries out annual reporting requirements;
- In collaboration with the Executive Director for Research
Integrity and Compliance, oversees quality assurance and quality
improvement initiatives;
- Directs biological and radiation safety during emergencies and
planned special events at the university;
- Coordinates with Environmental Health and Safety to manage
oversight of the EHS Research Specialist;
- Oversees management of and ensures development for staff to
meet overall objectives;
- Provides leadership and communication to maintain a competent
and engaged employee group;
- Identifies opportunities and takes action to build strategic
relationships between areas of oversight;
- Provides expert regulatory guidance to researchers, staff,
committee members, and leadership;
- Works with relevant GW offices to establish office web pages,
newsletters, and other tools;
- In collaboration with the Executive Director for Research
Integrity and Compliance, develops, delivers, and maintains
education and outreach programming;
- Oversees administrative management of protocols;
- Develops and maintains safety standards, policies, and standard
operating procedures;
- Ensures a safe and effective working environment;
- Employs a proactive approach in the optimization of safe and
high-quality outcomes;
- Performs other work-related duties as assigned.Minimum
Qualifications:Qualified candidates will hold a Bachelor's degree
in an appropriate area of specialization plus 8 years of relevant
professional experience, or a Master's degree or higher in a
relevant area of study plus 6 years of relevant professional
experience. Degree must be conferred by the start date of the
position.Preferred Qualifications:
- Master's degree in the biological sciences or related
discipline.
- Managerial experience is highly desirable.
- Thorough knowledge of federal regulations and guidelines
related to the oversight of laboratory animal research and use of
biohazardous materials in research.
- CIP CPIA credentialed or qualified to earn the designation
within one year of employment.
- Ability to plan, organize and carry out responsibilities
independently.
- Ability to set priorities, meet deadlines and manage multiple
projects.
- Strong interpersonal skills and the ability to effectively
communicate with university administrators, faculty, post-docs, and
students in a collegial manner.
- Exceptional attention to detail.
- Experience in laboratory animal research.GW offers a
comprehensive benefit package that includes medical, dental,
vision, life & disability insurance, time off & leave, retirement
savings, tuition, well-being and various voluntary benefits. For
program details and eligibility, please visit GW Benefits
Programs.Job DetailsCampus Location: Foggy Bottom, Washington,
D.C.Full-Time/Part-Time: Full time -> FTE 1.00Work Schedule:
Monday-Friday, 8am-5pmWill this job require the employee to work on
site? YesRequired Background Check: Criminal History Screening,
Education/Degree/Certifications Verification, Social Security
Number Trace, and Sex Offender Registry Search.EEO Statement: The
university is an Equal Employment Opportunity/Affirmative Action
employer that does not unlawfully discriminate in any of its
programs or activities on the basis of race, color, religion, sex,
national origin, age, disability, veteran status, sexual
orientation, gender identity or expression, or on any other basis
prohibited by applicable law.
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Keywords: The George Washington University, Charlottesville , DIRECTOR, REGULATORY OVERSIGHT, Executive , Washington, Virginia
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