Join the HJF Team!
HJF is seeking Clinical Research Manager I to support the Infectious Disease Clinical Research Program (IDCRP) located in Rockville, MD. HJF provides scientific, technical and programmatic support services to IDCRP.
Participates as a team member of the Infectious Disease Clinical Research Program (IDCRP) in supporting the development and execution of clinical research protocols related to multi-drug resistant infections, trauma- associated infections, travel- and deployment-related infections, skin and soft tissue infections, HIV/AIDS, sexually transmitted infections, acute respiratory infections, and other infectious diseases relevant to the military.
As a clinical research manager, the individual plays a central coordinating role in the implementation of research protocols, which may include FDA-regulated trials, in a multi-site, multi-disciplinary clinical research network based in Department of Defense medical treatment facilities in the US and abroad.
As a manager of protocol operations, the individual with direction by appropriate personnel:
- 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;
- coordinate the proposal submission and scientific/ethical review processes,
- manage protocol development activities,
- assist with protocol execution activities at clinical sites and the IDCRP Data Coordination Center,
- and ensure 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.),
- assists RADir with management-level tasks.
- Coordinates literature reviews and drafts scientific and technical documents under the direction of clinical investigators and other members of the investigative team.
- Coordinates with others to:
- prepare grant/funding applications,
- develop contracts with vendors,
- write progress reports for sponsors.
- coordinate execution of protocol-related tasks and monitor progress towards their completion.
- Must be able to obtain a Department of Defense Common Access Card. This process includes a background investigation that consists of a Federal Bureau of Investigation (FBI) fingerprint check and a National Agency Check with Written Inquiries (NACI) check.
- Other duties as required.
Required Knowledge, Skills, and Abilities:
- Knowledge of federal and local regulations and policies pertinent to research involving human subjects;
- Experience in the design and conduct of clinical trials and epidemiologic studies preferred;
- Prior experience in a clinical research environment;
- Knowledge of biomedical sciences and clinical research;
- Familiarity with clinical research methods, including studies utilizing randomized controlled trial, cohort, case- control, and case-series designs;
- Experience with utilization of electronic medical records preferred;
- Background in microbiology and infectious disease epidemiology preferred;
- Prior supervision, training, and mentorship of study personnel preferred;
- Knowledge of PCs including MS Word, Excel, and PowerPoint;
- Ability to use and train others on project management software;
- Ability to communicate effectively in written and oral form;
- Excellent verbal, written and interpersonal skills;
- Ability to effectively communicate research findings in presentations and publications;
- Prior presentation and publication record preferred;
- Ability to establish goals and agendas;
- Occasional travel may be required.
Minimum Education/Training Requirements: Bachelor’s degree in Biology or related field; Master’s degree in Epidemiology, Public Health or related field preferable.
Minimum Experience: 0–2 years of clinical research experience; educational experience (RN, MPH, or similar) may substitute for a portion of this.
Background: Eligibility to obtain a Common Access Card (CAC); eligibility to obtain and hold a Public Trust background.
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.