George Washington University: Director, Regulatory Oversight (Hybrid)

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.
 

The Director, Regulatory Oversight position responsibilities include overseeing the activities of the department staff, ensuring quality, productivity, functional excellence and efficiency to accomplish strategic and operational objectives. In addition, this position is accountable for employee engagement, adequate staffing levels, budget development and compliance, staffing decisions such as hiring and terminating employment, coaching and counseling employees on work related performance, and developing and implementing policies and procedures to ensure a safe and effective work environment. This position also ensures training, monitoring and operations initiatives are implemented which secure compliance with ethical and legal business practices and accreditation/regulatory/government regulations.

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. Ensures administrative teams are appropriately trained to provide comments to the applicable regulatory committees for consideration with submissions to assure that the review is conducted according to regulations and guidance;
• 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. In collaboration with the Executive Director, Research Integrity and Compliance, leads external agency inspections and audits; provides support for audits and inspections to investigators, administrative teams and regulatory committees (i.e. IRB, IACUC). Reviews agency reporting letters, communications with regulatory authorities, and assists with responses to internal and external investigations, audits and other matters.
• 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, including post-approval monitoring of animal research protocols;
• 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, and EHS/occupational health-related matters for the research program;
• Directs, develops and implements strategic and operational/high level projects and processes either through independent/highly autonomous work or through the facilitation of work teams to enable the effective and efficient completion of objectives;
• Oversees management of and ensures development for staff to meet overall objectives in terms of quality, service and cost effectiveness. Provides timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem. Directs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees;
• Provides leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/commendations to achieve desired outcomes;
• Identifies opportunities and takes action to build strategic relationships between areas of oversight, teams, schools & departments to achieve business goals. Drives the promotion of teamwork within and between schools/departments; participates and/or leads and facilitates department process improvements as needed;
• Provides expert regulatory guidance to researchers, staff, committee members, and leadership and partners internal and external to the organization. Serves as liaison between researchers & research teams, department management, committees & leadership related to areas of expertise;
• Works with relevant GW offices to establish office web pages, newsletters, marketing pamphlets, and other tools (educational content in areas of oversight, etc);
• In collaboration with the Executive Director for Research Integrity and Compliance, develops, delivers, and maintains education and outreach programming for the committees and the research community in areas of oversight to ensure compliance.
• Oversees administrative management of protocols, ensuring staff alignment with requisite expertise; ensuring appropriate staff coverage for regulatory operations;
• Develops and maintains and enforces safety standards, policies, and standard operating procedures;
• Ensures a safe and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/regulatory required safety guidelines. Responsible for staff maintenance of credentials and competencies, per accrediting/ licensing agency and/or department guidelines as applicable; Develops policies and procedures to ensure biosafety and radiation safety certifications are maintained by all relevant stakeholders;, decontaminations and moves are implemented safely and in accordance with regulatory requirements.
• Employs a proactive approach in the optimization of safe and high-quality outcomes and information systems by monitoring and improving the department workflow and enhancing operations, using peer-to-peer accountability and identifying solutions via collaboration. Implements process improvements utilizing tools such as lean principles. Role models situational awareness, using teachable moments to improve safety and quality.
• Performs other work-related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

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.
• Ability to set priorities, meet deadlines and manage multiple projects.
• Ability to interpret policies and procedures to solve unusual and/or difficult problems.
• Strong interpersonal skills and the ability to effectively communicate with university administrators, faculty, post-docs, and students in a collegial manner.
• Demonstrated written communication skills.
• Exceptional attention to detail.
• Experience using electronic protocol submission and review systems.
• Ability to maintain the confidentiality of sensitive information.
• Experience in laboratory animal research.
• Understanding of molecular and biochemical standard methods and cell culture in an academic research laboratory.