Join the HJF Team!
HJF is seeking a Regulatory Affairs Associate to support the Gynecological Cancer Center of Excellence (GYN-COE) Program at the Women’s Health Integrated Research Center in Annandale, VA, Walter Reed National Military Medical Center (WRNMMC) in Bethesda, MD and the Uniformed Services University of the Health Sciences (USUHS) in Bethesda, MD. The incumbent will also provide regulatory support as needed for subaward sites and collaborators to advanced funded research and initiatives at the WHIRC from USUHS, the Murtha Cancer Center Research Program (MCC-RP), collaborators and partners.
- Serve as the Regulatory Affairs Associate for the GYN-COE program and other funded research and initiatives at the WHIRC and the participating sites to ensure compliance with all requirements from HJF, Western Institutional Review Board (IRB), WRNMMC IRB, USUHS IRB, Inova Health System, other IRBs of record, Institutional Animal Care and Use Committees (IACUCs) of record, the Food and Drug Administration (FDA), the U.S. Department of Health and Human Services (DHHS), the Department of Defense (DOD), the Defense Health Agency (DHA) and other Sponsors for protocols involving human subjects or animals performed by or in collaboration with the GYN-COE, the MCC-RP, other awards and participating sites.
- Implement regulatory activities pertaining to the GYN-COE program and other funded research and initiatives at the WHIRC and the participating sites including protocol development, execution, amendment, continuing reviews, closures and termination of all protocols including exempt determinations and research involving human subjects or animals to address all regulatory requirements in a timely fashion and ensure continuous compliance with federal, state, local and sponsor regulations and policies of research involving human subjects, laboratory animals, and utilization of recombinant DNA. Register protocols on clinicaltrials.gov website as required.
- Serve as a point of contact with HJF headquarters, our subawards and collaborators, local IRBs, second level review IRBs, and IACUCs as well as the Office of Research Protection (ORP) and the Animal Care and Use Review Office (ACURO) for USUHS, DHA and other sponsors.
- Implement robust and proactive quality assurance reviews for IRB-approved protocols and consents, as well as clinical best practices, policies, standard operating procedures and compliance informatic systems, tools and security protocols in furtherance of the programs’ research involving human subjects or animals sponsored by the DOD and/or other funding sources.
- Assume responsibility for implementing comprehensive training initiatives for research ethics and compliance for prospective and retrospective investigations, clinical trials, interventions and prevention strategies involving human subjects for the GYN-COE program and other funded awards, programs and initiatives for investigators, staff and trainees as needed.
- Serve as the regulatory and compliance expert for the program performing gap analyses, providing recommendations and implementing priorities for research protocols, applications, reports, agreements, awards, and subcontracts.
- Act as the liaison and point of contact with the Tech Transfer Office at HJF Headquarters, our subawards, collaborators or partners to proactively facilitate and contribute to the development, modification and execution of a portfolio of agreements including Material Transfer Agreements, Data Use Agreements, and Tissue Use Committee approvals for research projects utilizing modular templates for multi-party agreements and both national and global multi-institutional collaborations.
- Use electronic systems for the Inova Research Center (IRC), Western IRB, WRNMMC, USUHS and other sites when necessary to either prepare and submit or review and edit applications, protocols, consents and other protocol related documents to IRBs, IACUCs, ORP, ACURO, investigators, subawards and collaborators as needed.
- Work with research staff to investigate issues and submit adverse event reports, changes in research, deviations, continuing reviews and other reports in a timely fashion, and to ensure that abstracts, manuscripts, posters and presentations have proper approval and clearances.
- Act as the Honest Broker for GYN-COE protocol-mandated research activities including the sharing of clinical data, acting as the lead POC in charge of consortium-wide honest broker activities, and ensuring compliance with all regulatory and training requirements of the GYN-COE honest broker system.
- Maintain a regulatory portfolio database and an honest broker database to ensure that the program electronic records or binders for legacy protocols are current at all times recording data, performing clerical tasks, running queries, generating reports, utilizing automated notification features and providing suggestions for improving tracking when needed.
- Provide written and verbal updates to the GYN-COE Executive Team including details, workload, action items, priorities, deadlines, deliverables and expirations.
- Maintain effective relationship with Principal Investigators, Program Administrators, Supervisor, IRBs, Laboratory Animal Review Committees (LARCs), Institutional Biologics Committee (IBCs), HJF Headquarters and Research Staff where GYN-COE or Foundation research are being conducted.
- Meet regularly with supervisor, Program Manager and HJF Regulatory Affairs to ensure that vulnerabilities are mitigated, and that appropriate details, deadlines and expirations are proactively tracked electronically to ensure that our Programs remain compliant and sound from a regulatory perspective.
- Monitor publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policies, compliance requirements and best practices.
- Completes other projects and assignments as needed.
Required Knowledge, Skills, and Abilities: Substantial knowledge of and experience with federal and local regulations, compliance requirements, and policies pertinent to research involving human subject, laboratory animals and recombinant DNA; excellent communication, interpersonal and organizational skills; ability to utilize computer applications and packages including Microsoft Word, Excel, PowerPoint, Outlook and REDCap. Experience with Filemaker pro, WIRB Connexus, IRBNet and/or eProtocol are a plus.
Minimum Education/Training Requirements: Bachelor’s degree in a scientific discipline or a related field is desired. Must maintain current training in human subject’s protection in research.
Minimum Experience: 4 - 6 years of experience in Regulatory Affairs with responsibilities for preparing, submitting and managing regulatory requirements for protocols involving human subjects and/or animals. Experience as a Regulatory Affairs Associate for a transdisciplinary program involving multiple national and/or global sites is preferred. Experience in clinical trials and/or translational research in a medical and/or scientific environment would be a bonus.
Physical Capabilities: Must be able to work at a computer station or on a laptop for lengthy periods of time; perform routine filing; handle large Regulatory Binders, stand for lengthy periods of time utilizing a copier for copying documents; travel to multiple sites in the National Capital Region.
Required Licenses, Certification, Registration and/or Credentials: Regulatory Affairs Certification (RAC) and/or Certification as an Honest Broker are preferred.
Work Environment: Office environment for the GYN-COE in Annandale, VA typically four days a week and at WRNMMC in Bethesda, MD or HJF Headquarters in Bethesda, MD typically one day a week as needed. Local travel can be anticipated about 20% of the time.
Background: U.S. Citizenship required; eligibility to obtain and hold a Secret Security Clearance.
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.