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.
  • Set up and coordinate work plans and delivery timelines, project management plans, communication plans, and other project start-up documentation.
  • Draft work orders and change orders to maintain contractual alignment of studies.
  • Support project management leads in planning, implementation, conduct, management, tracking, and reporting of assigned projects within established timelines and budgets.
  • Assist in tracking project deliverables to ensure quality and timeliness of all project-related tasks and actively manage project risks, actions, issues, and decisions (RAID).
  • Schedule project meetings and facilitate communication with internal and external stakeholders.
  • Coordinate activities between Everest and trial sponsors, as well as various supporting groups or third-party vendors.
  • Support timely and accurate maintenance of study information in various systems and documents.
  • Perform invoicing, billing, and general financial management and analysis of projects.
  • Support compliance of all documentation required for the Project Management team to support audit readiness and compliance.
Qualifications and Experience:
  • Bachelor of Science or Master of Science in life sciences or health-related field.
  • Experience in the delivery of clinical trials is typically a requirement, however, a willing, eager, and quality-focused individual may learn and develop successfully.
  • Two (2) years of clinical research experience within a pharmaceutical, biotechnology, or Contract Research Organization setting is preferred.
  • Exposure to and demonstrated understanding of cross-functional processes, including clinical operations, statistics, data management, subject randomization and drug supply management, data monitoring and adjudication committees, regulatory affairs, and medical writing.
  • Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
  • Ability to assist in developing general project management deliverables, including project plans, project scope, drafting budgets, project management trackers, agendas, and meeting minutes.
  • Ability and experience in working with numbers and simple business quantitative calculations to support budget generation, reviews, and checking, and project performance analysis.
  • Demonstrated confidence and flexibility, with ability to adjust to multiple demands and shifting priorities.
  • Excellent interpersonal, oral, and written communication skills.
  • Detail-oriented individual, with the ability to accurately and professionally present all deliverables to the highest quality.
  • Strong ability for critical thinking and quantitative (business) skills.

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