Senior Clinical Research Associate

Location: Boston, Massachusetts, USA
Salary: US$55 - US$70 per hour + negotiable
Job Type: Contract
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Senior Clinical Research Associate

A growing Boston pharmaceuticals company is seeking a Senior Clinical Research Associate to join their Clinical Operations team. As a Clinical Research Associate you will be responsible for field monitoring and assisting site coordinators. The Clinical Research Associate should have excellent organizational and communication skills.

Key Responsibilities

  • Ensuring documentation meets FDA/GCP/ICH requirements
  • Assist in the design of study protocols, case report forms, consent forms *Review study records including case report forms, consent forms, and other materials
  • Assist site coordinators, investigators, field clinical staff, CRO in collecting data
  • Organize data to allow for efficient and accurate clinical reports
  • Review, reconcile, and maintain TMF for multi-center, multi-national clinical trial(s)
  • Perform pre-qualification, site initiation, routine monitoring and site close-out visits and conduct co-monitoring visits with CRO staff at participating sites
  • Serve as a resource to site coordinators, investigators, and other staff members regarding protocols.
  • Assist in writing the clinical study reports as well as the clinical portion of Regulatory submissions
  • Maintain in-house study trackers (enrollment, screening, start-up progress, etc.)
  • Manage study site payments and vendor payments

Requirements

-Bachelors degree in a related field

-2-5 years of CRA experience

-Ability to travel up to 35%

Sthree US is acting as an Employment Business in relation to this vacancy.

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