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Director of Regulatory Compliance

2 months ago

Washington, Washington, D.C., United States The George Washington University Full time
Job Summary

The Director of Regulatory Oversight is a key leadership position responsible for ensuring compliance with federal regulations and guidelines related to laboratory animal research and the use of biohazardous materials in research. This role requires a strong understanding of regulatory requirements and the ability to provide strategic leadership and operational direction to the Office of Human Research and Office of Research Safety teams.

Key Responsibilities
  • Provide strategic leadership and operational direction to the Office of Human Research and Office of Research Safety teams
  • Oversee 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
  • Serve as Human Protections Administrator (HPA) on GW's Federal Wide Assurance (FWA)
  • Ensure a thorough review of research protocols prior to submission to the regulatory committees for review
  • Facilitate maintenance of AAALAC accreditation and support and oversee AAHRPP accreditation
  • Direct semi-annual facility inspections and program reviews
  • Serve as a key contact in communications with regulatory agencies and accrediting bodies
  • Lead external agency inspections and audits, and provide support for audits and inspections to investigators, administrative teams, and regulatory committees
  • Review agency reporting letters, communications with regulatory authorities, and assist with responses to internal and external investigations, audits, and other matters
  • Communicate with federal and accrediting oversight authorities and carry out annual reporting requirements
  • Oversee quality assurance and quality improvement initiatives, including post-approval monitoring of animal research protocols
  • Direct biological and radiation safety during emergencies and planned special events at the university
  • Coordinate with Environmental Health and Safety to manage oversight of the EHS Research Specialist, and EHS/occupational health-related matters for the research program
  • Direct, develop, and implement strategic and operational/high-level projects and processes
  • Oversee management of and ensure development for staff to meet overall objectives in terms of quality, service, and cost effectiveness
  • Provide timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem
  • Direct management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees
  • Provide leadership and communication to maintain a competent and engaged employee group
  • Identify opportunities and take action to build strategic relationships between areas of oversight, teams, schools, and departments to achieve business goals
  • Drive the promotion of teamwork within and between schools/departments
  • Participate and/or lead and facilitate department process improvements as needed
  • Provide expert regulatory guidance to researchers, staff, committee members, and leadership and partners internal and external to the organization
  • Serve as liaison between researchers & research teams, department management, committees, and leadership related to areas of expertise
  • Work with relevant GW offices to establish office web pages, newsletters, marketing pamphlets, and other tools (educational content in areas of oversight, etc)
  • Develop, deliver, and maintain education and outreach programming for the committees and the research community in areas of oversight to ensure compliance
  • Oversee administrative management of protocols, ensuring staff alignment with requisite expertise; ensuring appropriate staff coverage for regulatory operations
  • Develop and maintain and enforce safety standards, policies, and standard operating procedures
  • Ensure a safe and effective working environment; monitor and/or revise 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
  • Develop policies and procedures to ensure biosafety and radiation safety certifications are maintained by all relevant stakeholders
  • Employ 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
  • Implement process improvements utilizing tools such as lean principles
  • Role model situational awareness, using teachable moments to improve safety and quality
Requirements
  • 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
  • Additional Required Licenses/Certifications/Posting Specific
  • 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
  • CIPCPIA 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