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.

HJF is seeking a Clinical Research Manager II to manage in the implementation of clinical research protocols and provide project management. Comprehensive oversight of operational aspects of assigned clinical trials and research protocol.

This position will be in support of the Center for Neuroscience and Regenerative Medicine (CNRM). The Project Manager will play a central coordinating role in the implementation of clinical research protocols focused on the study of traumatic brain injury in DoD medical treatment facilities.

• Interacts regularly with clinical investigators, clinical site coordinators, regulatory and safety monitoring staff, laboratory personnel, data coordination center personnel, data analysts, biostatisticians, program managers and administrative staff.
• Coordinates the execution of clinical research proposals, coordination of the proposal submission and scientific/ethical review processes, management of protocol development activities, oversight, and guidance of protocol execution activities at clinical sites, and ensuring project completion and final product development (e.g., presentation and/or publication, recommendations for changes in clinical practice, provision of pivotal data for product licensure, etc.).
• Conducts literature reviews and drafts scientific and technical documents under the direction of clinical investigators and other members of the investigative team.
• Makes recommendations for process improvements and/or enhancements. Contributes to the design and overall goals of the quality control and quality assurance plan for a study, when needed.
• Contributes to the development and modifications of study budgets and is responsible for budget compliance and development/tracking of protocol performance metrics.
• May include budgetary responsibility to include plan/forecast and prepare.
• Adheres to compliance and privacy/ confidentiality requirements and standards, including DOD specific regulations and guidance. Adheres to GCP and compliance regulations for clinical trials.
• 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.

• In addition to the knowledge, skills and abilities required of a study coordinator.
• ability to write progress reports in a clear and concise manner.
• excellent organizational, communication and interpersonal skills.
• ability to establish goals and agendas.
• Strong self-management and organizational skills.
• Excellent knowledge of clinical trial processes.
• thorough knowledge of GCP, human subject research, or equivalent regulations.

• Direct Supervisor:Direct authority to make decisions on the following: employee hiring, disciplinary action, starting salaries and merit increases; conduct employee performance evaluations and directs work activities.

• This position will take place primarily in an office setting.

• Bachelor's Degree in Life sciences, scientific disciplines or equivalent. Masters preferred.
• Minimum of 6-8 years experience required

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.