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Clinical Trial Associate

  • Ref: 284743
  • Type: Long Term Contract
  • Location: Groton, CT
  • Industry: Pharmaceuticals
  • Job Level: Experienced Non-Manager
  • Pay: Negotiable

Opportunity Description

We are currently seeking a Clinical Trial Associate to join an amazing opportunity to be involved in a top notch pharmaceutical company, where you will be applying your prior experience to this new and exciting position.

Company Information

Our client, a vibrant and growing player in their field, invites potential candidates to involve themselves in their latest research study. As a member of their community, you will be providing support for the planning, execution, and financial aspects of the project.

Job Duties

  • Assist as needed with the general work of keeping up with clinical functions as they intersect with other functional areas.
  • Responsible for oversight of vendors/consultants, which includes communicating timelines, negotiating contracts, preparing purchase requisitions, and coordinating related activities.
  • Assist in the development, maintenance, training, and record keeping Clinical SOPs and guidelines in accordance with GCP, ICH, and FDA Guidelines.
  • Actively participate in design, development, and review of study protocols, reports, and case report forms to ensure compliance with GCP, ICH, and FDA guidelines.
  • Provide management support for activities with outside vendors and business partners, as required.
  • Support preparation activities for FDA and other applicable regulatory body meetings
  • Travel may be required (up to 30% of the time) based on department needs
  • Reports study metrics and other critical information to project management using study trackers, data forms, and report
  • Assists Clinical Project Manager (CPM) with the tracking and review of safety events
  • Assists in the development of critical study documents, including clinical protocols, ICFs, operational documents, study reference documents, study newsletters, site materials, and other study-related documents
  • Provides vendor management support to CPM
  • Assists data management, CPM, and monitors by driving site data entry and query resolution.

Experience & Skills Required

  • High energy individual able to effectively multi-task, priority set, and strive in a dynamic environment.
  • Excellent communication (oral and written), organizational, and problem-solving skills.
  • Able to quickly grasp concepts and instructions
  • Individual will possess attention to detail, requiring little revision to work produced
  • Overall understanding of early to late stage clinical trial process
  • Strong attention to detail
  • Prior experience in monitoring clinical trials and data.