Bethesda, Maryland

Overview

Join the HJF Team!

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing, and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

HJF is seeking a Regulatory Compliance Specialist to assist in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects' research, and Health Insurance Portability and Accountability Act (HIPAA). Additionally, this position will assist with site feasibility, Institutional Review Board initial submissions, and working closely with Program Managers to prepare documentation to meet pre-award and study initiation requirements.

This position will be in support of the Center for Neuroscience and Regenerative Medicine (CNRM), in Bethesda, MD. CNRM is a federal military traumatic brain injury (TBI) research program organized as a partnership between the Uniformed Services University and the National Institutes of Health. CNRM supports a wide range of research from pre-clinical models to investigational projects and clinical trials research on TBI and its comorbidities. This position will work directly with the CNRM Clinical Trials Unit in support of day to day regulatory overview of multiple sponsored and collaborative studies within Uniformed Services University Health System and participating treatment facilities nationwide.

Responsibilities

  • Assists under the guidance of the Director of the Clinical Trials Unit with the regulatory components of protocols, grants, contracts, and other research activities to ensure compliance with relevant federal and local regulations and polices of research involving human subjects' and HIPAA.
  • Assists with maintaining a regulatory database and tracking database to include data entry and reports.
  • Ensures required protocols are registered, maintained, and results are posted in clinicaltrials.gov.
  • Assists with the review of research files to ensure GCP compliance have been met, informed consent forms have been completed appropriately, and that the principal investigator is maintaining the necessary regulatory files and subject research documents.
  • Acts as primary Point of Contact for CNRM sponsored studies and HJF Regulatory Affairs office including attending regularly scheduled meetings. Liaises with Sponsor and other entities and collaborators as needed. Monitors and keeps up-to-date on regulatory policy focusing on IRB and site
  • Works closely with Sr. Clinical Trials Specialist to assess site feasibility and identify site specific regulatory requirements.
  • Assists with the completion of IRB initial package submissions for strategic and collaborative studies.
  • Works closely with Program Management team to provide input on pre-award documentation and helps complete regulatory requirements.
  • Reviews and writes standard operating procedures (SOPs) and other regulatory affairs policies as necessary.
  • May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Required Knowledge, Skills and Abilities
  • Knowledge of federal and local regulations and policies pertinent to research involving human subject, HIPAA.
  • Excellent communication and writing skills, interpersonal and organizational skills.
  • Must be a self-starter, able to work independently, and able to multi-task.
  • Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, cloud-based eRegulatory platforms, and E-mail.
  • Regulatory compliance (human subjects research, GCPs) experience required.
  • Quality Assurance experience preferred.
  • Department of Defense experience/policy preferred.

Qualifications

Work Environment
  • This position will take place primarily in an office setting.
  • Hybrid work, at 2-3 days in office.

Education and Experience
  • Bachelor's Degree is required.
  • Minimum of 3-5 years of experience required.

Licenses and Certifications
  • Certified as a Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), and/or Clinical Research Professional (CCRP) preferred.

All HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.

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, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

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Bethesda, Maryland

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is a global organization dedicated to advancing military medical research. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.

The not-for-profit Foundation is authorized by Congress to support research at the Uniformed Services University of the Health Sciences (USU) and throughout military medicine. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. The Foundation’s support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and to accomplish their research goals effectively and efficiently.

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