Clinical Project Coordinator

Everest Clinical Research (“Everest”) is a full-service, global, contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO, including clinical operations. Everest’s headquarters are located in Markham Ontario, Canada with additional locations in: Bridgewater, New Jersey; Shanghai, China; Taipei, Taiwan; and multiple offices in Europe.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength that’s us that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a** Project Coordinator**for our Toronto/Markham, Ontario, Canada on-site location.

**Key Accountabilities**:

- Act as a supporting team member within the Project Management Team and assist project management activities for assigned Phase I to IV clinical trials and in accordance with ICH guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
- Support effective and efficient coordination of projects and tasks across the entire clinical trial and project/portfolio management lifecycle in the following areas:

- Business development
- Project start-up
- Project maintenance and delivery
- Project closure and archival
- Perform project initiation administration tasks (e.g., set-up file folder/project folders, documentation and training maintenance, invoicing templates, etc.).
- 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 the planning, implementation, conduct, management, tracking and reporting of assigned projects within the established timelines and budgets, as well as with the quality required by Everest and general industry regulatory standards.
- Assist in the tracking of project deliverables to ensure quality and timeliness of all project-related tasks and actively manage project risks, actions, issues, and decisions (RAID). Maintain accurate and current details for communication to internal and potentially external stakeholders.
- Schedule project meetings (internal and external), as well as facilitate and communicate assignments, priorities, and expectations to the cross-functional project delivery teams. Draft meeting agendas and minutes, ensuring support and approval of key stakeholders.
- Assist in the coordination of activities between Everest and trial Sponsors, as well as various supporting groups or third-party vendors if applicable (e.g., central laboratories and other specialty laboratories) to ensure that all contractual obligations are met and that any interdependent activities are coordinated effectively, and timelines planned for accordingly.
- Facilitate ad hoc requests to coordinate and follow-up on critical path tasks.
- Support timely and accurate maintenance of study information in a variety of systems and documents, such as the training matrix/tracker and work management tools.
- Perform invoicing, billing, and general financial management and analysis of projects, supporting healthy project financial performance. Maintain up-to-date financial Work Order and billing tracking.
- Support compliance of all documentation required for the Project Management team to support audit readiness and compliance; this includes, but is not limited to the following: creation and maintenance of study-specific training documentation, training matrices, and trackers. Support training follow-up across functional leaders to ensure project-specific training compliance, as well as support training compliance administration.
- Under the guidance of project leadership, ensure successful project team mobilization and communication throughout the project lifespan. Ensure and proactively track project milestones, deliverables, and overall success. This includes, but is not limited to, the following:

- Assist in project kick-off meetings (internal and external, as applicable), coordinating and tracking the dissemination of key project assumptions and information to relevant stakeholders.
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