Clinical Project Coordinator

3 weeks ago


Markham, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Clinical Project Coordinator

Everest Clinical Research Services Inc is seeking a highly skilled and detail-oriented Clinical Project Coordinator to join our team. As a Clinical Project Coordinator, you will play a crucial role in the planning, execution, and delivery of clinical trials.

Key Responsibilities:
  • Support project management activities for assigned clinical trials, ensuring compliance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
  • Coordinate project tasks and activities across the entire clinical trial lifecycle, including business development, project start-up, project maintenance and delivery, and project closure and archival.
  • Perform project initiation administration tasks, such as setting up file folders, documentation, and training maintenance.
  • Develop and maintain project management plans, communication plans, and other project start-up documentation.
  • Assist in the tracking of project deliverables, ensuring quality and timeliness of all project-related tasks and actively managing project risks, actions, issues, and decisions (RAID).
  • Coordinate project meetings, facilitate communication among project team members, and ensure that all stakeholders are informed and aligned.
  • Support the coordination of activities between Everest and trial sponsors, as well as various supporting groups or third-party vendors.
  • Perform invoicing, billing, and general financial management and analysis of projects, ensuring healthy project financial performance.
  • Support compliance of all documentation required for the Project Management team to support audit readiness and compliance.
Requirements:
  • Bachelor of Science or Master of Science in life sciences or health-related field.
  • Experience in the delivery of clinical trials, preferably in a pharmaceutical, biotechnology, or Contract Research Organization setting.
  • Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
  • Ability to develop general project management deliverables, including project plans, project scope, and project management trackers.
  • Excellent interpersonal, oral, and written communication skills.
  • Detail-oriented individual with the ability to accurately and professionally present all deliverables to the highest quality.
What We Offer:

Everest Clinical Research Services Inc offers a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.



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