What are the responsibilities and job description for the Research Coordinator I position at Henry M. Jackson Foundation?
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.
This position will be in support of the Department of Neurology at Uniformed Services University. We are looking for a new team member to provide regulatory and administrative support to the project entitled "Acute AHI Investigations" being conducted at USUHS and led by Dr. David Brody. This project involves gaining a deeper understanding of US Government employees who have reported acute signs and symptoms consistent with previous reports of Anomalous Health Incidents (AHI), formerly known as "Havana Syndrome." The regulatory and administrative assistant will provide support for human studies regulatory activities, coordination with multiple federal agencies, calendar support, documentation of activities, document management, travel coordination logistics, and coordination with research partners.
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.
- Plans, conducts, and completes investigations under supervision.
- Performs routine data analysis and verifies and corrects data entry.
- Maintains records and documentation regarding assigned research.
- The position requires prompt (within 1 hour) and 100% reliable responses to emails, phone calls and text messages during regular business hours.
- 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 Biosafety Committee actions.
- Must be able to set and meet deadlines.
- Experience with human studies regulatory activities is required.
- Good communication and analytical skills.
- Excellent attention to detail, including keeping track of multiple versions of documents and coordination lists, is required.
- Experience working with federal government agencies is preferred.
- The ability to obtain and/or maintain a T1 Public Trust with CAC.
Work Environment
- This position will take place primarily in a office/laboratory setting.
Compensation
- The hourly pay range for this position is $24.09-$31.25. Actual hourly pay will be determined based on experience, education, etc.
Benefits
- HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.
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.
Salary : $24 - $31
