About the position
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.
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.
- Prepares any addenda and/or annual progress reports, submitting adverse event/safety information to the IRB.
- Updates/maintains regulatory requirements such as updated investigator CVs, changes in principal investigator, FDA form 1572, etc.
- Maintains accurate, regulatory-compliant program/study binders.
- Performs research on background material pertaining to the clinical trials.
- Plans, conducts, and completes investigations under supervision.
- Performs routine data analysis and verifies and corrects data entry.
- Maintains records and documentation regarding assigned research.
- Coordinates efforts of all agencies involved in the protocol approval process.
- Makes and maintains contacts within the pharmaceutical industry.
- May include budgetary responsibility to include plan/forecast, prepare, approve, monitor.
- May perform other duties and responsibilities as assigned or directed by the supervisor.
Requirements
- Bachelor's Degree.
- Minimum of 0-2 years experience required.
- 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.
- Familiarity with Institutional Review Board activities and Institutional Biosafety Committee actions.
- Ability 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.
- Experience working with federal government agencies is preferred.
- Ability to obtain and/or maintain a T1 Public Trust with CAC.
Benefits
- Comprehensive suite of benefits focused on health and well-being, including medical, dental, and vision coverage.
- Health savings and retirement plans.
