Clinical Research Manager I (Infectious Disease Clinical Research Program)

Updated: September 11, 2019
Job ID: 215250
Status: Full-Time
Regular/Temporary: Regular
Location: Rockville, MD, United States

Join the HJF Team!

HJF is seeking Clinical Research Manager to support the Infectious Disease Clinical Research Program (IDCRP) located at 11300 Rockville Pike 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:

  1. 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.
  2. 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,
    • 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.).
  3. Coordinates literature reviews and drafts scientific and technical documents under the direction of clinical investigators and other members of the investigative team.
  4. Coordinates with others to;
    • prepare grant/funding applications,
    • develop contracts with vendors,
    • write progress reports for sponsors.
  5. Other duties as required.

Required Knowledge, Skills, and Abilities:

  • Knowledge of federal and local regulations and policies pertinent to research involving human subjects;
  • Knowledge of biomedical sciences and clinical research;
  • Familiarity with clinical research methods;
  • 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 preferable.

Minimum Experience: 1–2 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.
 

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