Research Coordinator II (Hybrid) Job at Henry M. Jackson Foundation for the Advancement of Military Medicine
Henry M. Jackson Foundation for the Advancement of Military Medicine Honolulu, HI
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 the 59th Medical Wing, Enroute Casulatly Care Department in the “Development of Enhanced Simulation Model with Biometric Cognitive Load Measurements for More Efficient En Route Care Training" projects.
HJF is seeking a Research Coordinator II to write, edit, document, and package protocols, consent forms and other regulatory documents for all assigned medical centers. Responsible for protocols from all sponsors (federal and non-federal) and completing all actions for the protocol to receive final IRB approval.
Responsibilities:
- Writes protocol applications and consent forms for Institutional Review Boards. Prepares and submits required institution and federal documentation for the conduct of the trial.
- Manages regulatory issues for all programs upon receipt of IRB approval. This includes preparing any addenda and/or annual progress reports, submitting adverse event/safety information to the IRB, updating/maintaining regulatory requirements such as updated investigator CVs, changes in principal investigator, FDA form 1572, etc. Also, maintains accurate, regulatory-compliant program/study binders.
- Performs research on background material pertaining to the clinical trials and uses this research to complete all protocol submissions.
- Negotiates contracts and develops cost-per-patient study budgets.
- Coordinate's efforts of all agencies involved in the protocol approval process. Makes and maintains contacts within the pharmaceutical industry.
- If applicable: May include budgetary responsibility to include plan/forecast, prepare, approve, monitor.
- 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).
- Must be familiar with Institutional Review Board activities and Institutional Biosafety Committee actions.
- Must be able to set and meet deadlines.
Work Environment:
- This position will take place primarily in an office/laboratory setting.
Education and Experience:
- Bachelor's Degree required.
- Minimum of 3-5 years experience required.
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)
About Henry M. Jackson Foundation for the Advancement of Military Medicine:
HJF is a 501(c)(3) 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.
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