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.

This position will be in support of HJF's Regulatory Affairs Department.

HJF is seeking a Regulatory Affairs Coordinator to be responsible for assisting in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA). Responsibilities includes identifying problems and works with senior staff to implement solutions. The incumbent will report directly to the Director, Office of Regulatory Affairs & Research Compliance. This position requires US Citizenship.

Responsibilities

  • Assists with the review of protocols, grants, contracts, clinical trials and other research activities to ensure compliance with relevant federal and local regulations and polices of research involving human subjects, laboratory animals, select agents, utilization of recombinant DNA and HIPAA.
  • Assists with maintaining a regulatory database and tracking database to include data entry, queries, and reports. Prepares regulatory binders (paper and electronic) for protocols assigned in their portfolio to be audit ready.
  • Ensures required protocols are registered and up to date in clinicaltrials.gov.
  • Reviews research personnel training for assigned portfolio to ensure that participating personnel have received appropriate training in human subjects research protection, HIPAA, animal research protection, Good Clinical Practices, conflicts of interest in research, responsible conduct in research, and shipping dangerous goods have been completed.
  • Maintains effective liaison with research staff and PIs in assigned portfolio.
  • Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy.
  • Review and process research participant travel and reimbursement and request for clincards.
  • Maintain excellent customer service with the research staff under the assigned portfolio.
  • 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 and familiarity with the Institutional Review Board (IRB) and human subjects protection training required.
  • Knowledge of federal and local regulations and policies pertinent to research, ideally involving human subjects, laboratory animals and recombinant DNA, HIPAA.
  • Excellent communication and writing skills, interpersonal and organizational skills, must be a self-starter and be able to work independently, must be able to multi-task.
  • Ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, and E-mail.

Qualifications

Work Environment
  • This position will take place primarily in an office setting. The incumbent may be required to conduct site visits to various military and civilian hospitals and/or research labs where HJF supported research is being conduct. Site visits includes local travel as necessary.

Education and Experience
  • Bachelor's Degree in scientific discipline or related field required.
  • Minimum 0-2 years of experience required.

Licenses and Certifications
  • CCRA, CCRP, or CCRC is preferred. Training in human subject's protection in research 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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