Sr. clinical trial coordinator – São Paulo/SP

SP | São Paulo
Efetivo (CLT)
Biólogo
Médico Veterinário

Responsibilities include, but are not limited to

• Trial and site administration:
  • Track (e.g. essential documents) and report (e.g. Safety Reports)
  • Ensure collation and distribution of study tools and documents
  • Update clinical trial databases (Clinical Trial Management System) and trackers
  • Clinical supply & non-clinical supply management, in collaboration with other country roles
  • Manage Labeling requirements and coordinate/sign translation change request, in collaboration with other country roles (if applicable)
• Document management:
  • Prepare documents and correspondence
  • Collate, distribute/ship, and archive clinical documents, e.g. eTMF (electronic Trial Master File)
  • Assist with eTMF (electronic Trial Master File) reconciliation
  • Execute eTMF (electronic Trial Master File) Quality Control Plan
  • Update manuals/documents (e.g., patient diaries, instructions)
  • Document proper destruction of clinical supplies.
  • Prepare Investigator trial file binders
  • Obtain translations of documents
• Regulatory & Site Start-Up responsibilities:
  • In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
  • Obtain, track and update study insurance certificates
  • Support preparation of submission package for Institutional Review Board / Ethics Review Committee and support regulatory agencies submissions.
  • Publish study results for Global Clinical Trial Operations and Regulatory Affairs where required per local legislation
• Meeting Planning:
  • Organize meetings (create & track study memos/letters/protocols)
  • Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
• Quality & Oversight:
  • Contribute strongly to Sr Clinical Trial Coordinator team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
  • Mentors / buddies junior Sr Clinical Trial Coordinators (including, but not limited to process requirements)

Requirements

• Solid experience in pharmaceutical companies and/or Clinical Research Organizations (CROs)
• Bachelor degree on Health or Life Science field
• Advanced English skills