Contract - Clinical Trials Assistant

Location
San Francisco, CA, United States
Posted
Sep 11, 2019
Ref
594
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
CONTRACT - CLINICAL TRIALS ASSISTANT

Position Summary:

The Clinical Trials Assistant (CTA) is responsible for providing support to the lead Clinical Trial Manager and the study execution team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites. The CTA will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with GBT SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.

Essential Duties and Responsibilities:
  • Support one or more study execution team (SETs), including scheduling meetings, distributing agendas and meeting minutes.
  • Document outstanding action items with expected completion dates and responsible individual(s). Follows-up on all SET action items.
  • Track and maintain study information and report on study progress.
  • Track and provide IRB/IEC submission documentation and other supplementary documentation, as appropriate.
  • Obtain, reviews, process, and track study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.).
  • Maintain and ensure the completeness of the Trial Master File (TMF) in accordance with SOP requirements.
  • Maintain accurate tracking and reporting of study management data.
  • Maintain and disseminate basic study tracking information including, but not limited to: Visit Reports, Regulatory Documents, Site Contact Lists, Team Contact Lists, Vendor Lists, and Budget Disbursements.
  • Manage and track Investigational Product supplies for study centers; receives and prepares requests, ships and returns Investigational Product supplies.
  • Prepare, ship and manage inventory of study related supplies.
  • Assist in preparing materials for investigator meetings, workshops, and study manuals.
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.

Qualifications:
  • Bachelor's degree or equivalent or combination of relevant experience and training.
  • Previous experience as a CTA preferred, but not required.
  • Excellent organizational skills and attention to detail.
  • Ability to efficiently perform multiple tasks and manage changing priorities.
  • Ability to identify and solve logistical problems.
  • Demonstrate proficiency in Microsoft Word, PowerPoint and Excel.
  • Take direction well.