Clinical Research Associate II

Staff Name: 
James L. Gulley, M.D., Ph.D.
Genitourinary Malignancies Branch
Job Category: 
Clinical Trials/Patient Care
Multiple Positions Available: 
Research Area Keywords: 

clinical research, site management, regulatory, IRB

Position Description: 
  • Prepares and presents technical reports, abstracts, manuscripts, and other scientific presentations
  • Secures electronic file transmissions of medical records, tests (ECG, MRI, CT, etc.) through various portals that are provided by trial sponsors
  • Develops Standard Operating Procedures, templates and flow diagrams to enhance workflow
  • Monitors/prepares budget operating reports
  • Provides project management support with planning and development of project schedules and deliverables
  • Develops and tracks project timelines and milestones
  • Prepares status reports and monitoring progress ensuring adherence to deadlines
  • Assists the research nurses with queries from research sponsors
  • Maintains relationships with Investigators, study site staff, network entities, Clinical Research Organizations (CROs) and field CRAs
  • Provides assistance to the clinical investigators and teams to reinforce and enhance a GCP culture
  • Assists other CRAs and Project Managers in the development of team processes and study-related documents
Number of Positions: 
C.V. Required: 
Number of References Required: 
Experience Required: 
  • Possession of a Bachelor’s degree from an accredited college/university in a field related to biomedical research, clinical trials and/or health (Additional qualifying experience may be substituted for the required education)
  • Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirements, a minimum of two (2) years of progressively responsible experience in biomedical research including a minimum of one (1) year directly related to overseeing multiple concurrent trials/sites and on-site clinical monitoring or clinical sites management experience
  • Ability to work in a clinical research setting, both independently and within a team
  • Ability to prioritize multiple tasks/projects and accomplish goals in expected timelines through effective organizational and planning skills
  • Ability to communicate effectively, verbally and in writing, with non-technical and technical staff
  • Knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and ICH/GCPs
  • Proficiency with Microsoft Office products including Microsoft Word, Outlook and Excel
  • Experience with electronic or remote data capture monitoring as well as paper based monitoring
  • Previous clinical on-site monitoring or site management experience
  • Must be able to obtain and maintain a security clearance

Candidates with these desired skills will be given preferential consideration:

  • ACRP Certified CRA or SOCRA Certified Clinical Research Professional
  • Infectious diseases experience
  • Knowledge of Department of Health and Human Service (DHHS) regulations
  • Experience conducting federally funded studies
  • Experience developing Case Report Forms (CRFs), eCRFs, manual of operations and study monitoring plans
  • Knowledge of international regulatory requirements
Additional Information: 

This position is being recruited through Leidos Biomedical Research, Inc.

How To Apply: 

Please apply directly to the website link provided below.

Contact Name: 
Lauri Rimorin
Contact E-mail: 
Contact Phone: 
Contact Fax: 

HHS, NIH, and NCI are Equal Opportunity Employers