Regulatory Compliance Administrator (#1864)

BACKGROUND

The National Biodefense Analysis and Countermeasures Center (NBACC) is a one-of-a-kind facility located on Fort Detrick in Frederick MD and is dedicated to defending the nation against biological threats. Its work supports DHS and National biodefense preparedness planning, response, emerging threat characterization and bioforensic analyses. It is the first national laboratory created by DHS in response to biodefense gaps identified following the Amerithrax attacks of 2001 and has been operated by the Battelle National Biodefense Institute (BNBI) since 2006. Since its inception, NBACC and its staff have filled critical shortfalls in our scientific knowledge of biological agents needed to protect the public and defend the Nation from biological threats, whether naturally occurring, accidental, or deliberate and provided federal law enforcement with scientific data to support the investigation and attribution of biocrimes and protection of the US bioeconomy.

NBACC includes two centers: the National Bioforensic Analysis Center (NBFAC), which conducts the technical analyses in support of federal law enforcement investigations, and the National Biological Threat Characterization Center (NBTCC), which conducts experiments and studies to obtain data required for a better understanding of biological vulnerabilities and hazards. Together these centers offer a unique national resource for understanding the risks posed by biological agents and emerging technologies to inform biodefense policy and response planning and the operational capability to support the investigation, prosecution, and prevention of biocrimes and bioterrorism.

PRIMARY FUNCTION

Coordinates activities of the NBACC Institutional Regulatory Committees in accordance with all applicable laws, regulations, policies, and guidelines. Committees to be supported include the Institutional Animal Care and Use Committee (IACUC), the Institutional Biosafety Committee (IBC), the Institutional Safety Committee (ISC), the Institutional Review Committee (IRC), and the Human Subjects Research Committee (HSRC). Provides broad technical regulatory support and overall coordination to the Chairpersons and members of the Committees.

MINIMUM REQUIRED QUALIFICATIONS

• Bachelor's degree (or equivalent), with a minimum of 4 years of relevant experience in specialized administration, biomedical sciences, quality assurance, research ethics, or related field. Experience in related regulatory work is required.
• Prior experience as an IACUC or IBC administrator is required.
• Detailed knowledge of applicable federal regulations related to IACUC, animal welfare, human subjects research, and recombinant DNA is highly desirable.
• Certified Professional IACUC Administrator (CPIA) certification is desirable, or the ability to obtain within one year of employment.
• Experience with Microsoft Office (Word, Outlook, Excel, PowerPoint, Visio), Microsoft SharePoint, Adobe Acrobat, Adobe Live Cycle Designer, and others.
• Prior experience with IACUC, IBC, or IRB management software is desirable.
• Proficiency and clarity in both written and oral communication is essential.
• Must possess strong organizational and interpersonal skills and have a proven track record of working independently and as a team player.
• Strong work ethic with ability to prioritize and manage multiple projects simultaneously with multiple stakeholders.
• Skills and experience to support laboratory activities and work in accordance with NBACC's management system (e.g., ISO).
• Must be a citizen of the United States, able to obtain and maintain an interim secret clearance leading to a top-secret clearance and suitability for DHS.
• Participation in the Immunization Program, Medical Surveillance Program, and/or enrollment in the Personnel Reliability Program (PRP) may be required, dependent upon position and/or business needs.
• May be required to participate in NBACC's alternative work schedule and/or on-call schedule, dependent upon business needs.

PRIMARY RESPONSIBILITIES

• Serves as the liaison between Principal Investigators (PIs), Institutional Official (IO), other staff and the IACUC, IBC, ISC, IRC, and HSRC. This includes providing timely and accurate guidance to PIs and staff regarding the requirements of, and submissions to, each committee.
• Provides regular reports and maintains open communication with the IO, providing updates of committee business activities, program status and any compliance-related concerns identified by the committees.
• Oversees the protocol submission process from start to finish, which includes pre-reviews, committee review, and executing decisions and correspondence to researchers to convey determinations of projects. Ensures that State/Federal regulations, accreditation standards, and institutional policies, requirements, and procedures are consistently applied to all protocols prior to submission for review by the designated committee.
• Attends and supports the planning and coordination of all institutional regulatory committee meetings.
• Develops meeting schedules, arranges meeting rooms, prepares meeting agendas in collaboration with the appropriate committee chair, oversees protocol preparation and distribution to reviewers, provides all necessary materials for meetings, attends meetings, and records, prepares, revises, and publishes the meeting minutes.
• In conjunction with Committee Chairs, provides training for committee members and NBACC personnel on committee procedures, requirements, and changes in regulatory guidance.
• Interfaces between Committee Chairs and the General Counsel/Legal Office regarding coordination of responses to Committee inquiries from the public.
• Coordinates regulatory activities and assists in the collection, preparation, and submission of compliance-related documents and reports. This includes the USDA, PHS, DHS, and AAALAC Annual Reports.
• Oversees all aspects of the IACUC Semiannual Program Reviews and Facility Inspections.
• Manages the maintenance, updates, and submission of the AAALAC Int'l Program Description. Serves as the lead point of contact for the AAALAC Site Visits, including pre- and post- correspondence and communication.
• Oversees the maintenance of current databases of all protocol and project related files and documentation of committee records.
• In conjunction with Committee Chairs, receives and classifies reports of events related to the IACUC or IBC. Tracks and records reported events and assists in determination of reporting requirements. Serves as point of contact for reporting to oversight agencies.
• Participates as a Post-Approval Monitoring Compliance Liaison for the IACUC, conducting audits of approved IACUC protocols.
• Provides monthly reports of each committee to the Infrastructure Operations Director and Committee Chairs.
• Develops, reviews, and revises NBACC policies, SOPs, and forms governing committee activities according to external regulatory requirements.
• Fosters close integration and communication between each committee and other closely associated elements of the institution such as Environmental Health and Safety, security, quality assurance, facilities maintenance, and training.
• Oversees and manages the budgets for each committee.
• Remains fully informed of changing regulations and federal guidance as it applies to the use of animal subjects, human subjects, and recombinant DNA in research and applies this knowledge to NBACC's regulatory committees.
• Must be a team player, communicate clearly, be open to hearing ideas and suggestions from others, diffuse situations, and exercise empathy and patience with colleagues.
• Must have the ability to multi-task, maintain composure under pressure, and utilize effective time management skills to prioritize tasks.
• Must be a self-starter driven by an eagerness to succeed, maintain flexibility, adapt to change in a productive and positive manner, learn new concepts, and utilize critical thinking to resolve complex problems.
• Maintains appropriate records.
• Performs other duties as assigned/authorized.

BNBI prohibits discrimination and employs and advances individuals without regard to race, color, religion, age, sex, national origin, disability or veteran status.