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Clinical Trial Associate II

Norwood, MA 02062

Post Date: 08/03/2018 Job ID: 2000 Job Category: Clinical: Clinical Operations and Development

The CTA II assists the study team across all investigator sites and ensures compliance with protocol and overall clinical objectives. The experienced CTA II performs project/study management-related responsibilities by coordinating and tracking activities for clinical trials in compliance with protocol, Standard Operating Procedures (SPOs) and regulatory guidelines from the inception of the protocol through the database lock process. To accomplish this, the CTA II works closely with all functional areas as well as with external providers to ensure consistent, high-quality outcomes.

Working independently on most assignments while only typically requiring instructions on new assignments, the CTA II understands that this is a role where additional growth and learning is integral. The successful candidate is highly organized and identifies tasks/issues that need to be addressed while multitasking and adjusting direction based on changing project/corporate priorities.

Primary Responsibilities:
  • Ensure study activities are executed according to study protocol, regulatory guidelines and operational plan.
  • Review Investigational Drug Brochures (IDB), Protocols, Case Report Forms (CRFs) and informed consent forms (ICFs) for a thorough understanding of the study drug and procedures.
  • Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines, state and national laws and ethical standards.
  • Participate in study start-up, conduct and closeout activities
  • Assist preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWs
  • Collect and review site regulatory documents for accuracy and completion (1572, Financial Disclosure documents, CLIA waivers, etc.).
  • Assemble and distribute regulatory binders to clinical sites
  • Draft and/or assist with the preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
  • Support project management activities including taking meeting minutes/providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study status trackers
  • Assist preparation and distribution of investigator site contracts and budgets
  • Maintain the Trial Master File for all clinical projects

Skills & Requirements:
  • 2-3 years of experience in industry.
  • Experience in a CRO or Sponsor preferred.

Anna Korelis

Anna is a creative problem solver who prides herself on her strong work ethic and expert communication skills. Goal-oriented and service-driven, Anna has a keen eye for the skills that enable her candidates to stand out, and digs deep to understand what motivates them to find their next opportunity.

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