1-617-500-6690 [email protected]
  • Full Time (Salaried)
  • Boston, MA

Company:  Confidential

Job Title: Clinical Trial Associate/Senior Clinical Trial Associate

Job Number: 32278

Location: Boston, MA

Job Description

The Clinical Trial Associate provides clinical trial coordination support to the assigned clinical trial or trials.  This support includes study deliverable tracking and completion of study documentation including eTMF is maintained for the assigned clinical trial(s).  This position will work with internal clinical team members and with external vendors and CROs.  The position reports to the Clinical Operations Program Lead.  This role may work collaboratively on one program or across several trials to support clinical operations activities.

Responsibilities

  • Coordination support from start up to close out for assigned trials
  • Ongoing eTMF maintenance and completion with CRO for assigned trials
  • Meeting coordination and documentation
  • Tracking of action items for clinical deliverables
  • Reconciliation and tracking of purchase orders and invoices for assigned trials
  • Daily study management for assigned clinical trial(s) or assigned region in larger studies
  • Ownership of clinical trial tracking documents
  • May include clinical sample tracking and coordination
  • Ensure trial management documentation is conducted in accordance with  ICH/GCP standards
  • Develop and maintain strong, collaborative relationships with multiple cross functional team members

Required Skills

  • At least 2 years of trial coordination experience in a clinical research environment, with at least some within the biotech/pharma industry
  • Bachelor’s Degree in a life-science-based subject
  • Oncology therapeutic experience is preferred
  • Basic understanding of drug development
  • Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
  • Good verbal and written communication skills
  • Good organizational skills and attention to detail

 

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