Project Manager, Clinical Trials - DBH

Join the HJF Team!

HJF is seeking a Project Manager, Clinical Trials to provide clinical trial leadership and project management. Comprehensive oversight of operational aspects of assigned clinical trials and research protocol. This position is equivalent to the third of four levels within the Clinical Manager series.

This position will be in support of the Walter Reed National Military Medical Center (WRNMMC) Directorate of Behavioral Health (DBH). This Project Manager role will support a DoD-funded single-site study of MDMA-assisted therapy for active duty, guard, and reserve service members with post-traumatic stress disorder to be conducted at WRNMMC.

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.

• Contributes to defining trial objectives with sponsor or PI initiated studies and develops scope and schedules with sponsor and/or PI to meet their goals. Contributes to the effective design and implementation of clinical strategy, clinical plan and study protocol.

• Identifies risks and challenges associated with sites/studies/protocols and develop proactive solutions and performs site feasibility assessments.

• Creates study plans and prepares progress reports independently.
• Develops and maximizes internal and external relationships while acting as a liaison between study sponsors, the laboratory and study sites.
• Monitors progress of study submissions and eligibility review activities. Ensures current reports are submitted in a timely manner. Interfaces with IRB and drafts IRB applications, amendments, continuing reviews, etc. as necessary.
• Makes decisions for day-to-day operations of projects including the resolution of technical problems and questions from project staff. Collaborates with site coordinators, PI, sponsor or designee, and QA/QC personnel to facilitate Program operations.
• 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.
• 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.

Supervisory Responsibilities:

• 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.

Education and Experience

• Bachelor's Degree in Life sciences or a related scientific discipline required.
• Minimum of 6-8 years experience required.

Required Knowledge, Skills and Abilities

• 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.
• US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.

Physical Capabilities

• Lifting: Requires lifting materials up to 10 lbs.
• Ability to stand or sit at a computer for prolonged periods.

Work Environment

• This position will take place primarily in a clinical setting.

Compensation

• The annual salary range for this position is $73,800-$100,000. Actual salary will be determined based on experience, education, etc.

Benefits

• HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.

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.