- Assists human subjects' research activities, to include clinical trial protocol development, study operational procedures and forms development, and study implementation within the Directorate in collaboration with Department of Defense, governmental, non-governmental, academic, and industry partners.
- Provides coordination of human subjects' research activities, to include Phase 1 and 2 clinical trials, within the Directorate; guidance on volunteer screening, consent, specimen collection and storage, and product storage; and ensures regulatory files are complete.
- Serves as the primary liaison with institutional review boards involved in human subjects' research at the NMRC, Walter Reed Army Institute of Research (WRAIR), Army Office of the Surgeon General, Navy Bureau of Medicine, and review boards at other off-site locations.
- Serves as a primary liaison between relevant laboratory personnel, clinical investigators, collaborating institutions, and/or commercial partners for clinical trial operations.
- Supports clinical research implementation and ensures ongoing compliance with mandated study procedures and guidelines.
- Performs research administration duties to support clinical research activities and reporting.
- Develops, modifies, and assists in the modification of clinical trial protocols and ancillary documents, epidemiological protocols, study reports, and manuscripts; and maintains study-related documents.
- Adheres to legal, professional, and ethical codes with respect to confidentiality and privacy. Assures that protocol-related activities are performed in compliance with Good Clinical Practice and other federal and Department of Defense regulations.
- Travels from their assigned workplace to support protocols at other sites as needed.
- 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.
- Bachelor's Degree required, preferably within the life sciences.
- Minimum of 0-2 years experience required.
- Knowledge of federal and local regulations and policies pertinent to research involving humans.
- Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
- Excellent interpersonal and computer skills, including experience with MS Office products (MS Outlook, MS Excel, MS Word, MS Teams) and Adobe Professional.
- Ability to communicate effectively and to work with individuals of all levels.
- Ability to obtain and maintain a T1/Public Trust background check.
- This position will take place primarily in a research/office setting.
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Clinical Research Coordinator I - Silver Spring, United States - Henry M. Jackson Foundation
Description
OverviewJoin the HJF Team
HJF is seeking a Clinical Research Coordinator I to assist in the conduct of clinical research in conjunction with one or more specified clinical research protocols.
Developing adherence to legal, professional, and ethical codes with respect to confidentiality and privacy helps ensure that protocol requirements are achieved in accordance with Good Clinical Practice.
This position will be in support of translational and clinical research within the Infectious Diseases Directorate (IDD) at the Naval Medical Research Command (NMRC).
The incumbent is tasked with supporting and conducting high-quality translational and clinical research to facilitate the development of infectious disease countermeasures for US military personnel.
Within the Directorate is the NMRC Clinical Trials Center (CTC), a 3,500 square foot state-of-the-art facility located in Bethesda, MD that is equipped to conduct Phase 1 and 2 outpatient clinical trials.
The NMRC CTC evaluates vaccines, therapeutics, prophylactics, and medical devices in human subjects to suitably advance innovative products from the laboratory to the front line and maximize the medical readiness of the Warfighter.
This position will work within the Directorate to support clinical research activities.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.
Note:
This work site requires that Non-US Citizen incumbents have lived in the US three out of the past five years.
ResponsibilitiesEducation and Experience
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 c)Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer