Project Coordinator
Premier Research - Philadelphia, PA

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POSITION SUMMARY:

The Project Coordinator (PC) supports the Project Manager in management of assigned project(s). The Project Coordinator supports the Project Manager in ensuring all project deliverables are met according to project timelines, budget, operational procedures and quality standards. The PC may be assigned specific project activities to manage independently.

The Project Coordinator plans, coordinates, and tracks project activities and facilitates team communication under the supervision of the Project Manager ensuring compliance with SOPs, policies, working guidelines, good clinical practices, and applicable regulatory requirements and completion in accordance with contract and customer expectations.

ACCOUNTABILITY

The Project Coordinator:
  • Supports the PM in development of project plans, project timelines and tracking tools.
  • Organizes and centralizes communications internally and externally to ensure reporting and status tracking is adhered to and is escalated as appropriate
  • Maintains, updates and disseminates monthly progress reports, and project plans with project specific information collected from the functional groups
  • Supports the Project Manager in updating and maintaining financial tools to track project budgets
  • Oversees maintenance of the Trial Master File
  • The Project Coordinator may be assigned to manage specific project activities to manage independently
RESPONSIBILITIES

  • For project success:
    • Under the supervision of the PM, develops and maintains project specific plans, customizes project templates and tracks project documents as needed
    • Manages the coordination and tracking of project-related information, status reports and communication across the project team and departments
    • Develops and maintains project communication tools including team contact lists, email distribution lists, and organizational charts
    • Supports efficient project team meetings, both internal and external, including scheduling, participation as necessary, preparation and distribution of meeting minutes, and maintenance of action item log
    • Supports the Project Manager with the set-up and maintenance of Premier Research key performance tools (i.e. PRF, PPR, HTC) and other study status reports as needed
    • Serves as back-up point of contact for Project Manager as well as back-up for completing financial tools and monitoring the project financial status
    • Conducts periodic review of electronic Trial Master File for accuracy and completeness
    • Assists in ensuring timely approval of pass-through invoices as assigned by Project Manager
    • Supports the Project Manager in liaising with third party vendors
  • Additional:
    • Acquires additional information and skills to enhance job performance, maintain an up-to-date knowledge of Premier Research systems, services, policies and procedures
    • Participates in corporate initiatives and actions that ensure the continued success of the company
    • Additional activities as delegated
    Required Skills Expertise and know-how
    • Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
    • Some knowledge of project management tools
    • Strong computer skills in MS Office required
    • Basic functional knowledge of MS Project preferred
    Personal skills & behaviors
    • Fluent verbal and written English is essential
    • Strong planning, tracking, and organization skills
    • Strong verbal and written communication skills
    • Excellent team player
    • Strong time-management skills
    • Ability to act proactively and coordinate multiple tasks to meet deadlines while focusing on quality standards
    • Work effectively in a fast-paced environment with competing priorities
    • Result-oriented approach and detail-oriented mindset to project delivery and output
    • Accountable, dependable and strong commitment
    • Is customer service focused in approach to work, both internally and externally
    • Maintains a positive, results orientated work environment
    Required Experience EDUCATION, SKILLS & COMPETENCIES:

    1. Educational background
    • Undergraduate degree in a clinical, biological, scientific, or health-related field or equivalent combination of education, training and experience
    2. Experience
    • Minimum 5 years relevant experience in clinical research
    • Prior management experience in health sciences research preferred
    3. Expertise and know-how
    • Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
    • Some knowledge of project management tools
    • Strong computer skills in MS Office required
    • Basic functional knowledge of MS Project preferred
    4. Personal skills & behaviors
    • Fluent verbal and written English is essential
    • Strong planning, tracking, and organization skills
    • Strong verbal and written communication skills
    • Excellent team player
    • Strong time-management skills
    • Ability to act proactively and coordinate multiple tasks to meet deadlines while focusing on quality standards
    • Work effectively in a fast-paced environment with competing priorities
    • Result-oriented approach and detail-oriented mindset to project delivery and output
    • Accountable, dependable and strong commitment
    • Is customer service focused in approach to work, both internally and externally
    Maintains a positive, results orientated work environment

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