Join the HJF Team!

HJF is seeking a Clinical Research Manager II to oversee the Naval Medical Research Command (NMRC) Clinical Trials Center (CTC) research portfolio. Work includes coordinating activities with higher-level managers, supervising and assisting other clinical research staff, and dealing with complex problems to deliver solutions. This is the second of three Clinical Research Manager levels.

This position will be in support of translational and clinical research within the Defense Infectious Diseases Directorate (DIDD) at 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 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 NMRC CTC to support those clinical trial 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.

Responsibilities

• Develops and manages comprehensive budgets for clinical research studies at the NMRC CTC.
• Establishes and manages a variety of contracts/agreements for executing clinical research studies at the NMRC CTC.
• Forecasts personnel, supply, equipment, space, and service needs for executing clinical research studies at the NMRC CTC; drives and/or supports efficient, effective, and novel solutions for (and tracking of) these needs.
• Oversees timeline planning and tracking for clinical research studies in conjunction with Departmental leadership and other clinical research staff; develops and maintains tools to effectively oversee the NMRC CTC research portfolio and ensure compliance with applicable regulations.
• Organizes and drives internal and external study team meetings.
• Serves as the point of contact for clinical research study sponsors.
• Serves as the direct supervisor for clinical research staff.
• Interacts regularly with clinical investigators, clinical research staff, regulatory and safety monitoring staff, laboratory personnel, data coordination personnel, data analysts, biostatisticians, program managers, and administrative staff to ensure center- and/or project-specific needs are being communicated and met.
• Coordinates with program managers and Departmental leadership to prepare grant/funding applications, develop contracts/agreements, write progress reports for sponsors, and track various aspects of the program related to research administration (e.g., personnel management, development and oversight of project budgets, etc.).
• 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.
• Assists with monitoring audits/visits for protocols.
• Assists with the ordering/procurement of supplies, equipment, and/or services as needed.
• 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 the role.

Supervisory Responsibilities

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

Qualifications

Education and Experience

• Bachelor's Degree in Biology, Epidemiology, Public Health or related field.
• Minimum of 9-10 years experience required.
• Willing to consider Master's Degree with 6 years of experience.

Required Knowledge, Skills, and Abilities

• Knowledge of federal and local regulations and policies pertinent to research involving human subjects.
• Prior experience and a well-rounded background serving in a clinical research environment; knowledge of biomedical sciences and clinical research.
• Budgetary and Acquisition experience in clinical trials is preferred.
• Excellent organizational skills and attention to detail; excellent oral and written communication skills.
• Excellent computer skills, including experience with MS Office products (MS Outlook, MS Excel, MS Word, MS Project, MS Teams) and Adobe Professional.
• Excellent interpersonal skills and the ability to communicate effectively, manage effectively, and work with individuals of all levels.
• Holds a valid driver’s license.
• Experience supervising others is preferred.
• Ability to obtain and maintain a T1/Public Trust background check.

Physical Capabilities

• Lifting: Requires lifting materials up to 25.
• Ability to stand or sit at a computer for prolonged.
• Ability to climb, pull, and lift heavy.
• Operating motor vehicles, machinery, and/or power tools.

Work Environment

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

Some HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will 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.

Job Type: Full-time

Schedule:

• Monday to Friday

Work setting:

• In-person
• Office

Work Location: In person