Clinical Research Manager II – Infectious Diseases Clinical Research Program – Rockville, MD (COVID-19)

Join the HJF Team!

HJF is seeking a Clinical Research Manager II to support the Infectious Diseases Clinical Research Program (IDCRP) located at in Rockville, MD. HJF provides scientific, technical and programmatic support services to IDCRP.

The incumbent manages in the implementation of clinical research protocols.

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), coordination of the proposal submission and scientific/ethical review processes, management of protocol development activities, oversight and guidance of protocol execution activities at clinical sites and the IDCRP Data Coordination Center, and 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. Serves as the direct supervisor of clinical research site personnel.
4. Conducts literature reviews and drafts scientific and technical documents under the direction of clinical investigators and other members of the investigative team.
5. Serves as a liaison between review committees (e.g. journal and conference reviewers) and other members of the investigative team.
6. Coordinates with program managers to prepare grant/funding applications, develop contracts with vendors, write progress reports for sponsors and track various aspects of the program related to research administration (e.g. personnel management, development and oversight of project budgets, etc.).
7. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Required Knowledge, Skills and Abilities: Knowledge of federal and local regulations and policies pertinent to research involving human subjects; experience in the design, conduct and analysis 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

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

Minimum Experience/ Training Requirements: 6-8 years of relevant work experience.

Background/Security: Eligibility to obtain and maintain a Tier I investigation/Public Trust and a Common Access Card (CAC).

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.