Join the HJF Team!
HJF is seeking a Clinical Research Manager II to support the Infectious Disease Clinical Research Program (IDCRP) in Rockville, Maryland. HJF provides scientific, technical and programmatic support services to IDCRP.
This position participates as a team member of the 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 the primary manager of protocol operations and budget, the individual:
- 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.
- Organizes and coordinates the execution of clinical research proposals,
- assists in the writing of protocols and associated documents (e.g., manuals, consent documents, data collection forms),
- coordinate the proposal submission and scientific/ethical review processes,
- manage protocol development activities,
- oversight and guidance of 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.)
- Conducts literature reviews and
- drafts scientific and technical documents under the direction of clinical investigators and other members of the investigative team, and
- serves as a liaison between review committees (e.g., journal and conference reviewers) and other members of the investigative team
- Responsible for development/tracking of protocol performance metrics
- Organizes and coordinates with program managers of the IDCRP Program Coordination Center to
- prepare grant/funding applications,
- develop contracts with vendors,
- write progress reports for sponsors,
- contributes to the development and modifications of study budgets and is responsible for budget compliance, and
- tracks various aspects of the program related to research administration (e.g., personnel management, development and oversight of project budgets, etc.)
- 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;
- 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;
- Basic knowledge of microbiology and infectious disease epidemiology;
- Knowledge of PCs including MS Word, Excel, and PowerPoint;
- Ability to write clearly and concisely;
- Excellent communication and interpersonal skills;
- 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 preferred
Minimum Experience: 2–4 years of clinical research experience, including at least 1 year in clinical research management position; educational experience (RN, MPH, or similar) may substitute for a portion of this.
Background: 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.
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 Director of Human Resources.