Clinical Trial Associate

Key responsibilities:

  • Provide support to clinical trial manager(s) for all phases of study conduct (feasibility, start-up, maintenance and close-out) of clinical trials.
  • Assist with meeting planning for clinical trial activities including vendor, investigator, consultants, safety boards, data monitoring committees, and other external clients.
  • Assist in execution of Clinical Trial Communication plan, including coordination of site teleconferences, blast communication, newsletters.
  • Attend study team meetings and prepare and distribute study team agendas and minutes as needed.
  • Assist in maintaining study status updates on a weekly basis (e.g., IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.).
  • Assist managers in tracking contracts, invoices and payments with SMOs, CROs, consultants, vendors and investigators, as appropriate.
  • Assist in the development of the structure of TMF and filing system and is responsible for filing and maintaining up to date study documents.
  • Provide regulatory agency inspection support by formatting, proof reading documents and contributing to the review of the Trial Master File.
  • Assist clinical trial manager(s) with preparation, handling and distribution of Clinical trial supplies and maintenance of tracking information.
  • Track in house training of CRO’s SOPs
  • Preparation and organization of Power Point presentations.
  • Preparation and maintenance of investigator information tracker for clinical trial operations.
  • Assist with clinical trial protocol and clinical study report (CSR) review, and support for documentation requirements for CSR appendices.
  • Provide support for external publications/presentations.
  • Assist with tracking of site approvals and denials of study participations.

 

Requirements:

  • Bachelor’s Degree.
  • Minimum 3-5 years of experience in related area.
  • Excellent planning, coordination, and time management skills to meet deadlines required.
  • Demonstrated organization skills and attention to detail.
  • Proficient computer skills (e.g. Microsoft Word, Excel, and PowerPoint) required.
  • Ability to work independently and with a team.
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