In-House Clinical Research Associate job in Bethesda at Technical Resources International
Technical Resources International

Job Info

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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.

Recommended Skills

• Irb
• Trial Master File
• Clinical Research Associate
• Clinical Research
• Clinical Trials
• Multitasking

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