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Sr. Clinical Trial Associate Needed for Expanding Biotech

  • Job type: Permanent
  • Location: Boston
  • Salary: Competitive
  • Job reference: Sr. CTA
  • Sector: Clinical, Clinical Operartions, EPM Scientific
  • Date posted: 23/03/2018
Sr. Clinical Trial Associate (Sr. CTA) Needed for Expanding Biotech
  • Rare Diseases | GCP/ICH Guidelines | EDC
  • Greater Boston Area
  • $50,000 - $85,000 + complete benefits package
An expanding biotech company is looking to hire a highly skilled Sr. CTA that will be responsible for contributing to the development of relevant concepts, techniques, and processes by assisting and helping lead the study team across all investigator sites. The Sr. CTA will act as a team lead or a mention in order to train junior team members.  

My client is a growing biotech company in late clinical stages that specializes in rare disease research. They are looking to add their first approved drug to the market in the near future.

The Sr. CTA will have responsibilities that include:
  • Ensuring compliance with protocol and overall objectives across all investigator sites
  • Performing project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines
  • Reviewing Investigational Drug Brochures, protocols, Case Report Forms, and Informed Consent Forms for a thorough understanding of study drug and procedures.
  • Participating in study start-up, and conducting and closeout activities
  • Maintaining the Trial Master File for all clinical projects
  • Assembling and distributing regulatory binders to clinical sites
  • Assisting with the preparation and distribution of investigator site contracts and budgets
The ideal candidate will have the following skill set:
  • +3 years of relevant experience
  • Monitor trials following company SOPs and in accordance with GCP/ICH guidelines.
  • Working knowledge and experience with EDC and CTMS preferred
  • Excellent verbal, communication, and written skills
  • Experience working with Phase I-III rare diseases preferred
  • Bachelor’s degree in the health sciences field required
 

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