Clinical Trial Specialist

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About the position

Responsibilities

  • Assists Clinical Trial Manager(s) with study, CRO and clinical investigative site management according to Good Clinical Practices, ICH Guidelines, local regulations, and Alnylam SOPs.
  • Creates and / or provides input into study management tools, monitoring tools and study manuals and training materials.
  • Maintains thorough understanding of applicable regulatory requirements and guidelines.
  • Serves as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols.
  • Provides input, tracks progress, and works to implement corrective action plans for study and individual site recruitment and retention plans.
  • Maintains accurate and timely Sponsor/site communication and correspondence.
  • Responsible for ensuring IMP and supplies accountability.
  • Plans and document Clinical Trial Working Group meetings for assigned program(s).
  • Add appropriate documents to the TMF and perform necessary quality reviews of the TMF.
  • Participates in company, departmental and project team meetings.

Requirements

  • BS/BA degree required; degree in healthcare scientific field preferred.
  • 1 - 2 years monitoring / CRO management or CRO oversight experience of clinical trials, including site management, or equivalent.
  • Knowledge of ICH GCP guidelines.
  • Excellent written and verbal communication, problem-solving, and interpersonal skills.
  • Strong attention to detail.
  • Effective organizational and time management skills.
  • Ability to collaborate with internal personnel, site and CRO staff.
  • Proficient with MS Office Suite (Excel, Word and PowerPoint), familiar with MS Project.
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