Project Coordinator

Everest Clinical Research (“Everest”) is a full-service 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. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China.

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 committed, skilled, and customer-focused individuals to join our winning team as **Project Coordinator** for our Little Falls, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.

**Key Accountabilities**:
The Clinical Project Coordinator (CPC) will act as a supporting team member within the Project Management Team. The CPC will support effective and efficient coordination of projects and tasks across the entire clinical trial and project/portfolio management lifecycle:

- Business Development
- Project Start Up
- Project Maintenance and Delivery
- Project Closure and Archival

The CPC core duties include, but are not limited to:

- Project initiation administration tasks (e.g., set up file folder/project folders, documentation and training maintenance, invoicing templates, etc.).
- Set up and coordination of work plans and delivery timelines, Project Management Plan, Communications Planning, and other project start up documentation.
- Drafting of work orders and change orders to maintain contractual alignment of studies.
- Scheduling project meetings, facilitating updates from project delivery teams, drafting meeting agendas and minutes, and active management of project risks, actions, decisions, and issues.
- Interface with study Sponsors, external third party vendors, Everest functional leaders, and sites where required to support project delivery activities.
- Facilitate _ad-hoc_ requests to coordinate and follow up on critical path tasks.
- Supports timely and accurate maintenance of study information in a variety of systems and documents such as the training matrix/tracker and work management tools.
- Performs invoicing, billing, and general financial management and analysis of projects, supporting healthy project financial performance. Maintains up-to-date financial work order and billing tracking.
- Supports the Project Team in ensuring inspection readiness for all aspects of study conduct.

**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’ clinical research experience within a pharmaceutical, biotechnology, or Contract Research Organization setting is preferred.
- Knowledge and understanding of ICH guidelines, FDA, Health Canada, and European Medicines Agency 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.