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Clinical Trial Associate

3 months ago

Walnut Creek, United States Meet Full time

Meet has partnered with a growing biotech in the neurology space seeking a Clinical Trial Associate to join the team. The Clinical Trial Associate (CTA) is responsible for the management of the clinical trial documents, review of the site file document, assisting with the planning and development of the study documents, and oversight of clinical trial documents while ensuring the trial documents are managed in compliance with the protocol, ICH/GCP, applicable regulatory requirements, and applicable SOPs/Work Instructions.


Responsibilities

  • Set up eTMF system, as appropriate
  • Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations
  • Handle incoming and outgoing shipments, as needed
  • Assist with all aspects of initial study drug release including regulatory packet review and study-drug release
  • Assist in the preparation of study-specific training materials
  • Support study team in IRB submission and updates
  • Manage study meeting calendar
  • Draft study meeting agendas and take study meeting minutes
  • Performs other work-related duties as assigned


Qualifications

  • A bachelor's degree in biology, life sciences, health sciences, healthcare administration, psychology or business.
  • At least 1-2 years of experience working in clinical trials, medical research, or a CRO.
  • Strong organizational skills and meticulous attention to details.
  • Excellent communication skills, both written and verbal.


Please reach out to Marina Menchero at marina@peoplewithchemistry.com if you'd like to learn more. This will be a fully confidential conversation.