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Director, Regulatory Oversight

2 months ago

Washington, United States George Washington University Full time

I. JOB OVERVIEW

The 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. 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.


In the performance of duties, the position will review, research, and interpret changes, trends and new developments related to areas of oversight; provide written analysis on specified topics; draft policies and procedures to implement and operationalize related initiatives; ensure regulatory review processes are standardized; develop strategies to enable implicated research departments and personnel to successfully adapt to changes; serve as a resource to the GW community regarding research matters in areas of oversight; maintain staff productivity; and resolve compliance, service and operational issues.


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. Serves as a key contact in communications with regulatory agencies and accrediting bodies;
  • 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;
  • Directs, develops and implements strategic and operational/high level projects;
  • 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, marketing pamphlets, 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 and enforces 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.

II. JOB DETAILS
Campus Location: Foggy Bottom, Washington, D.C.College/School/Department: Office Vice President of Research (OVPR)FamilyResearch AdministrationSub-FamilyResearch ComplianceStreamManagementLevelLevel 3Full-Time/Part-Time:Full time -> FTE 1.00Hours Per Week:40Work Schedule:Monday-Friday, 8pm-5pmWill this job require the employee to work on site?YesEmployee Onsite StatusHybridTelework:NoRequired Background Check:Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry SearchSpecial Instructions to Applicants:Employer will not sponsor for employment Visa statusInternal Applicants Only? NoPosting Number:S012538Job Open Date:12/11/2023Job Close Date:If temporary, grant funded or limited term appointment, position funded until:Background ScreeningSuccessful Completion of a Background Screening will be required as a condition of hire.EEO Statement:

The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities.

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