Clinical Research Manager III (Infectious Disease Clinical Research Program)

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Updated: August 21, 2019
Job ID: 215081
Status: Full-Time
Regular/Temporary: Regular
Location: Rockville, MD, United States

Join the HJF Team!

HJF is seeking Clinical Research Manager III to support the Infectious Disease Clinical Research Program (IDCRP) located in Rockville, Maryland and the Uniformed Services University (USU) in Bethesda, Maryland. HJF provides scientific, technical and programmatic support services to IDCRP. 

The incumbent 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.

The somewhat independent management of multicenter FDA-regulated clinical trials requires significant experience and specific training in this regard and is recognized as a higher level of responsibility for a Clinical Research Manager than managing observational and non-FDA-regulated trials.

Responsibilities:

  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. Develops, implements and oversees clinical research proposals, specifically;
    • 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.).
  3. Effectively delegates to and supervises protocol-specific tasks of available personnel.
  4. 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.
  5. Responsible for development/tracking of protocol performance metrics.
  6. 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
    • track various aspects of the program related to research administration (e.g., personnel management, development and oversight of project budgets, etc.).
  7. Works independently with some direction from lead researcher(s).
  8. 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 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/Training Requirements: Master’s degree in Epidemiology, Public Health or related field.

Minimum Experience: 4–6 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.

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.

Other: This position will travel between Portsmouth and Home Office and may travel to other sites as required.

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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