Clinical Research Associate I - Operational Undersea Medicine Directorate - Military Veterans

at Henry M. Jackson Foundation

Silver Spring, Maryland

Join the HJF Team!

HJF is seeking a Clinical Research Associate I to support the NeuroTrauma Department (NTD), within the Operational Undersea Medicine Directorate (OUMD), located at the Naval Medical Research Center in Silver Spring, MD. HJF provides scientific, technical, and programmatic support services to OUMD. U.S. citizenship required.

The incumbent will plan, coordinate, and monitor the execution of human subject research supporting a Neurotrauma and TBI research program at NMRC. Ensure that all necessary steps are taken towards safety provisions and all regulations are adhered.

NTD conducts research to develop novel strategies to prevent and treat TBI with particular attention given to developing early, far forward interventions for TBI alone or in combination with other injuries. The department is focused on blast-related injuries and conducts both animal and human studies of brain injury to assess neurocognitive, neuropsychological, and biomarker changes. Research efforts include studying blast biophysics, identifying the biological responses to blast exposure, and assessing the efficacy of promising therapeutic interventions to prevent and treat pathological changes associated with blast exposure.

NOTE: 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.

Responsibilities:
  1. Submits protocol application and consent forms on behalf of PI to local Institutional Review Board (IRB); familiarity with IRB porthole is preferred. (15%)
  2. Participates in preparing and reviewing consent forms and survey tools (questionnaires) for participant eligibility, protocol compliance, omissions, errors, etc. and files them as required. (10%)
  3. Ensures that all amendments, continuing reviews and adverse events have been submitted to the IRB and are up to date; and are reported to the PI. (10%)
  4. Maintains accurate regulatory compliant program/study binders for each study; both onsite and at the partnering facility. (10%)
  5. Efficient data entry for all research projects; to include responsibility for updates and maintenance of regulatory requirements such as the investigator's CVs, changes in PI, FDA form 1572, training records, license etc. (20%)
  6. Participates in field sample/data collection; including registering and coordinating study participants, organizing and administering questionnaires, assisting with transporting study equipment, and preparing bio specimens for storage and shipping. Also ordering these supplies and maintaining them. (35%)
  7. 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:
  • Working knowledge of a broad range of medical specialties.
  • Working knowledge of all applicable federal and military regulations regarding the use of human and animal subjects in research (e.g.: 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 314,45 CFR 46, FDA Form 1571, and FDA Form 1572).
  • Familiarity with Institutional Review Board activities and Institutional Biosafety Committee actions.
  • Must be able to set and meet deadlines.

Minimum Education: Master's degree required for this position.

Minimum Experience/ Training Requirements: Minimum of 0-2 years of experience required.

Work Arrangement: Some telework during COVID but not guaranteed afterwards.

Background/Security: U.S. citizenship required; eligible to obtain and maintain a Tier III Investigation/ Secret Clearance and Common Access Card (CAC).

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.

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

Silver Spring, 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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