TBI Research Activities Manager

Overview

Join the HJF Team!

HJF is seeking a TBI Research Activities Manager to manage the implementation of clinical research protocols. The individual is an expert in the role and has full autonomy.

This position will be in support of the Traumatic Brain Injury Center of Excellence (TBICoE) in Silver Spring, MD. TBICoE is a branch of the Research Support Division in the Research and Engineering Directorate (R&E) of the Defense Health Agency (DHA). DHA is a Federal Program within the Department of Defense (DoD). TBICoE, previously known as the Defense and Veterans Brain Injury Center (DVBIC), has been congressionally mandated since 1992 and is currently a matrixed research, dissemination, and knowledge translation program that supports warfighter brain health and readiness by advancing the traumatic brain injury state of the science and clinical standards.

TBICoE’s mission to support the warfighter is executed through subject matter experts embedded across DHA facilities with expertise in TBI clinical research investigations, surveillance, clinical tool development and training, cognitive monitoring and assessment, and dissemination of TBI tools, products, and education/training materials to DoD medical personnel, service members (including Guard, Reserve, and operational medics/corpsmen), veterans with TBI, and families/caregivers of the warfighter.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners, supporting military medical researchers and clinicians to achieve their research goals.

This position is contingent upon contract award.

• Leads the execution of analysis plans for primary and secondary study objectives.
• Reviews new concepts, protocols and sub-studies and assists in the selection of appropriate study design as well as development of preliminary analysis plans.
• 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.
• Develops, implements and oversees clinical research proposals, specifically the writing of protocols and associated documents (e.g., manuals, consent documents, data collection forms), 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 the IDCRP Data Coordination Center, 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.).
• Serves as the direct supervisor of clinical research site personnel.
• May include budgetary responsibility to include plan/forecast and prepare.
• 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.

• Direct Supervisor: Direct authority to make decisions on employee hiring, disciplinary action, starting salaries and merit increases; conduct employee performance evaluations and direct work activities. Supervises and oversees contract staff for administrative and personnel actions.

• Master's degree required;
  PhD in brain-health research (e.g., neurology, neuropsychology, neuroscience) with specialized experience in health science or project management related field is preferred. Experience with in one of the mentioned fields may be accepted in lieu of educational minimums.
• Minimum 4 years of experience working with government agencies and/or contracting required. Minimum 6 years clinical research execution, management, coordination, and/or oversight required. Prior research experience within the DoD/VA systems of care strongly preferred. Preferred experience in project management planning and its applicable tools.

• Knowledge and experience regarding the execution of human clinical research trials and federal research administration (e.g., budget management, project/grant management, personnel requirements, regulatory compliance, etc.).
• Ability to use sound judgment in complex problem solving and solution-focused response coordination and execution.
• Excellent interpersonal and communications skills.
• Ability to anticipate needs, take initiative and strong attention to details.
• Must adhere to legal, professional and ethical codes with respect to confidentiality and privacy.
• Experience in the design, conduct and analysis of clinical trials and epidemiologic studies.
• Experience with utilization of electronic medical records preferred; background in…