Clinical Research Manager III – Infectious Disease Clinical Research Program – Rockville, MD

Join the HJF Team!

HJF is seeking a Clinical Research Manager III to support the Infectious Disease Clinical Research Program (IDCRP) located in Rockville, MD. HJF provides scientific, technical and programmatic support services to IDCRP. US Citizenship is required.

The Clinical Research Manager III will support the development and execution of clinical research protocols focused on infectious disease threats to the US military. The IDCRP is a Department of Defense (DoD) program executed through the Uniformed Services University of the Health Sciences (USU), Department of Preventive Medicine and Biostatistics, through a cooperative agreement with HJF. This particular position will require the management of protocols addressing the epidemiology, treatment, and prevention of coronavirus disease 2019 (COVID-19).

As a clinical research manager, the individual will play a central role in the design, coordination, and implementation of research protocols in a multi-site, multi-disciplinary clinical research network based in DoD medical treatment facilities in the US and abroad. Current and future engagement of the IDCRP in multicenter, FDA-regulated treatment and prevention trials requires the candidate to have significant education, training, and professional experience in this domain.

Responsibilities:

1. Interact 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.
2. Develop, implement, and oversee clinical research proposals, specifically: (1)writing of protocols and associated documents (e.g., manuals, consent documents, data collection forms); (2) coordination of the proposal submission and scientific/ethical review processes; (3) management of protocol development activities; (4)oversight and guidance of protocol activities at clinical sites and the IDCRP Data Coordination Center; and (5) 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.).
3. Effectively delegates to and supervises protocol-specific tasks of available personnel.
4. Conduct literature reviews and draft scientific and technical documents under the direction of clinical investigators and other members of the investigative team.
5. Serve as a liaison between review committees (e.g., journal and conference reviewers) and other members of the investigative team.
6. Responsible for development/tracking of protocol performance metrics.
7. Coordinate with IDCRP program managers to: (1) prepare grant/funding applications; (2) develop contracts with vendors; (3) write progress reports for sponsors; (4) contribute to the development and modification of study budgets and be responsible for budget compliance; (5) track various aspects of the program related to research administration (e.g., personnel and resource management, etc.).
8. Perform other duties as required.

Required Knowledge, Skills and Abilities:

• Work independently with guidance from the lead investigator(s).
• Knowledge of federal and local regulations and policies pertinent to research involving human subjects.
• FDA regulated trials experience.
• Experience in the design and conduct of clinical trials and epidemiologic studies.
• Professional experience in a clinical research environment.
• Familiarity with clinical research methods, including studies utilizing randomized controlled trial, cohort, case-control, and case-series designs.
• Knowledge of biomedical sciences and clinical research.
• Basic knowledge of microbiology and infectious disease epidemiology.
• Knowledge of PCs including MS Word, Excel, and PowerPoint.
• Ability to use project management software.
• Ability to write clearly and concisely.
• Excellent communication and interpersonal skills.
• Ability to establish goals and agendas.
• Occasional travel may be required.

Minimum Education: Master’s degree in Epidemiology, Public Health, or related field required.

Minimum Experience/ Training Requirements: 10 or more years of clinical research experience, including at least 3 years in a clinical research management position; educational experience (RN, MPH, or similar) may substitute for a portion of this. FDA regulated trials experience a must have.

Supervisory Responsibilities: Prior supervisory experience required.

Travel: 10-15%

Background/Security: Eligibility to obtain and maintain a Tier I investigation/Public Trust and a Common Access Card (CAC). US Citizenship required for this position.

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, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.  

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.