Overview

Join the HJF Team!

HJF is seeking a Research Coordinator I to write, edit, document, and package protocols, consent norms and other regulatory documents for all assigned medical centers. Responsible for protocols from all sponsors (federal and non-federal) and completing all actions in order for the protocol to receive final IRB Approval.

The John P. Murtha Cancer Center at Walter Reed Bethesda is a modern, patient-centric, tri-service military health care facility. Its comprehensive core of military and civilian oncologists and other cancer-trained clinicians and researchers provide multidisciplinary cancer-care delivery and patient-family support services. Our Cancer Center, the only DoD Cancer Center of Excellence within the Military Health System, offers its patients access to cutting-edge cancer diagnostic and treatment technologies. This position will be in support of The Uniformed Services University of the Health Sciences, The Center for Military Precision Health, The American Genome Center, and the Applied Proteogenomics Organizational, Learning and Outcomes (APOLLO) Network.

Note: This work site requires that Non-US Citizen incumbents have lived in the US three out of the past five years.

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.

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 maintain 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.

Qualifications

Education and Experience

• Bachelor's Degree
• Minimum of 0-2 years experience required

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 14, 45 CFR 46, FDA Form 1571, and FDA Form 1572).
• Must be familiar with Institutional Review Board activities and Institutional Bio-safety Committee actions.
• Must be able to set and meet deadlines.

Physical Capabilities

• Lifting: Requires lifting materials up to 25 lbs.
• Ability to stand or sit at a computer for prolonged periods

Work Environment

• This position will take place primarily in a clinic setting.

Security Requirements: Ability to obtain and maintain a T Public Trust Investigation.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may 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.