The George Washington University
Director, Regulatory Oversight
The George Washington University, Washington, District of Columbia, us, 20022
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.ResponsibilitiesProvides 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;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;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. Degree requirements may be substituted with an equivalent combination of education, training and experience.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.Strong interpersonal skills and the ability to effectively communicate with university administrators, faculty, post-docs, and students.Demonstrated written communication skills.Exceptional attention to detail.Experience using electronic protocol submission and review systems.Ability to maintain the confidentiality of sensitive information.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.Job Details:Campus Location: Foggy Bottom, Washington, D.C.College/School/Department: Office Vice President of Research (OVPR)Full-Time/Part-Time: Full time -> FTE 1.00Hours Per Week: 40Work Schedule: Monday-Friday, 8pm-5pmRequired 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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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.ResponsibilitiesProvides 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;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;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. Degree requirements may be substituted with an equivalent combination of education, training and experience.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.Strong interpersonal skills and the ability to effectively communicate with university administrators, faculty, post-docs, and students.Demonstrated written communication skills.Exceptional attention to detail.Experience using electronic protocol submission and review systems.Ability to maintain the confidentiality of sensitive information.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.Job Details:Campus Location: Foggy Bottom, Washington, D.C.College/School/Department: Office Vice President of Research (OVPR)Full-Time/Part-Time: Full time -> FTE 1.00Hours Per Week: 40Work Schedule: Monday-Friday, 8pm-5pmRequired 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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