Clinical Trial Assistant

Department
Clinical Operations

Location
Redwood City, CA

Summary Description
The Clinical Trial Assistant (CTA) supports the Clinical Operations team in the initiation, management, and documentation of clinical trials. The CTA also supports the Clinical Contracts and Finance function in initiating, developing and executing contracts and tracking milestones and payments.

Responsibilities:

  • Assists the Clinical Operations lead in the coordination of activities for timely initiation and ongoing management of clinical trials
  • Assists in the design, distribution, collection, and collation of study related documents
  • Maintains a clinical trial management database (CTMS) of sites, Investigators, contractors and vendors
  • Provides regular updates on study metrics (site activation, screening, enrollment, study completion etc.)
  • Assists in the coordination of study team meetings, including scheduling and taking minutes.
  • Manages the Trial Master File (paper or electronic) and ensures the accuracy and timely entry of all documents stored there
  • Assists the Manager, Clinical Contracts and Finance with developing Requests for Proposals (RFPs), obtaining quotes, and developing clinical trial cost estimates
  • Assists with tracking site visits and site and subject payments
  • Under supervision, may directly contact clinical sites to conduct the above activities
  • Under supervision, may travel to clinical sites to assist with study monitoring duties
  • Other tasks as assigned by the Operations or Finance leads.

Qualification Requirements:

  • Associate’s Degree or equivalent, preferably in a business- or science-related area. Bachelor’s degree preferred.
  • Minimum of 1 year work experience in a clinical research or clinical finance environment
  • Good organizational and planning skills
  • Ability to work effectively in a team/matrix environment
  • Familiar with basic concepts of clinical research and regulatory documentation
  • Ability to understand technical, scientific and medical information with minimal to moderate explanation
  • Familiar with basic concepts of contracting and accounting
  • Ability to problem-solve
  • Competent with the Microsoft Office Suite (Word, Excel, Powerpoint)
  • Prior experience with eTMF, CTMS and EDC systems preferred
  • Good written and oral communication skills
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