In-House Clinical Research Associate at Technical Resources International

Posted in Other 24 days ago.

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Location: Bethesda, Maryland

Job Description:
The In-House Clinical Research Associate is responsible for supporting clinical study teams, primarily the field CRAs and the Project/Task Manager, as required on clinical trial administrative duties. Duties may include but are not limited to:
  • Assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation
  • Coordinate or assist in distribution of trial-related materials to study sites
  • May assist in preparing the Site Initiation Visit presentation or review of clinical monitoring plans
  • Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file held by TRI or Sponsor/Client
  • Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs
  • Track essential regulatory documents in a centralized web-based system and/or other database
  • Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems

NOTE: Specialized experience in eTMF (e.g., Veeva Vault) processing and system administration skills-sets and/or additional responsibilities may be required for some staff. This job may serve as a transition or training role for the position of field CRA, as appropriate.

Job Requirements
  • Bachelor's Degree in life sciences or another health-related field
  • Clinical trials /human subjects research experience with at least some knowledge of FDA/ICH GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO environment (e.g., In-house CRA, Study Coordinator, IRB Coordinator, Regulatory Coordinator/Associate): 1-3 years (preferred)
  • Understanding of medical and clinical trials terminology
  • Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution
  • Able to work independently or with minimal supervision as well as within a team
  • Excellent attention to detail with organizational and prioritization skills for efficient productivity
  • Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum)
  • Excellent professional writing and verbal communication skills (position requires clear phone and email communication)
  • Able to multi-task during the review/processing and preparation of essential regulatory documentation
  • Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right
  • Must have excellent time management skills, able to adhere to strict timelines and expectations
  • Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus
  • Experience with using a Trial Master File, a plus