Clinical Research Associate

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Updated: June 12, 2019
Job ID: 214816
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking a Clinical Research Coordinator to support the Surgery Department located at the Walter Reed National Military Medical Center (WRNMMC) in Bethesda, Maryland. HJF provides scientific, technical and programmatic support services to the Surgery Department. 

Participates as a key team member of the Peripheral Nerve Institute (PNI) to support the development, execution and close-out procedures for multiple clinical research protocols related to peripheral nerve injuries. As a Clinical Research Coordinator, the individual plays a central coordinating role in the implementation of research protocols in a multi-site, multi­ disciplinary clinical research network based in Department of Defense medical treatment facilities and civilian clinical trial sites. The Clinical Research Coordinator will report to the Program Director and will work closely with Principal Investigators to execute clinical trials and conduct funded research programs and support the development of new clinical trial proposals and new clinical research programs.

Responsibilities: 

  1. Interacts regularly with Principal Investigators, clinical site coordinators, regulatory and safety monitoring staff: laboratory personnel, data coordination center personnel, data analysts, biostatisticians 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, material transfer agreements, cooperative research and development agreements), 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 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. Conducts literature reviews and drafts scientific and technical documents under the direction of clinical investigators and other members of the investigative team.
  4. Coordinates with the Program Director 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.
  5. Reviews new concepts, protocols and sub-studies and assists in the selection of appropriate study design as well as development and execution of plans to meet primary and secondary study objectives.
  6. Recruit instruct and coordinate enrollment and participation of research subjects and/or volunteers, as appropriate to specific study objectives and work scope under CFR, GCP and ICH guidelines.
  7. Organize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate to research objectives.

Required Knowledge, Skills, and Abilities: Must have experience and 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; knowledge and proficiency  in statistical analysis. Knowledge and experience with logistic regression, general linear models with repeated measures, survival analyses, and other statistical techniques for longitudinal and missing data; experience with utilization of electronic medical records preferred. Prior supervision and mentorship of study personnel preferred; ability to communicate effectively in written and oral form; ability to effectively communicate research findings in presentations and publications; prior presentation and publication record preferred; excellent verbal, written 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:  0 - 2 years plus of clinical research experience; experience and proficiency in military eIRB and HRPO submissions preferred.

Background: US Citizenship required; eligibility to obtain and hold Department of Defense issued Secret Clearance.

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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