Clinical Project Coordinator

Our growing cardiovascular clinical research client is looking to add a Clinical Project Coordinator to their team who would be a key point of communication between the clinical sites and project management.

Responsibilities of the Clinical Project Coordinator include but are not limited to:

  • Pre-study qualification of investigators/site for clinical trials
  • Guidance to other team members (Clinical Project Coordinators and Clinical Trial Assistants)
  • Start-up of multi-center trials: regulatory document collection and review, study document/materials collation and distribution
  • Trial Master File organization
  • Collection of essential documents
  • Preparing Study related documents/materials
  • Informed Consent reviews
  • Site Regulatory Package reviews
  • Ability to effectively train clinical sites on study processes/systems
  • Clinical site management
  • Effective communication between site staff, sponsor, internal staff members
  • Participate in project team meetings
  • Knowledge of FDA/GCP regulatory requirements
  • Knowledge of Excel, Word  and study systems
  • Ability to work on multiple activities concurrently
  • Other special projects as assigned by Project Management

 

Position Requirements:

  • 3 or more years in a clinical research position (Site Research Coordinator, CRA, CTA)
  • Understanding of Clinical Research Development Programs
  • Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
  • Deep understanding of essential documentation and IRB/Ethics Committee submissions
  • Effective communication skills
  • Strong computer skills including but not limited to the knowledge of a Clinical
  • Maintain a basic knowledge and ensure compliance with applicable ICH-GCP Guidelines,
  • Good oral and written communication skills to internal and external customer
  • Ability to prioritize multiple tasks and achieve project timeline
  • High commitment to and performs consistently high-quality work
  • Good written English skills
  • Background in nursing or other clinical field is preferred

If interested, please reach out to Earl Callender at ecallender@daleyaa.com.

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