Clinical Project Coordinator

2 weeks ago

Van Nuys, California, United States Research & Development Institute, Inc. Full time
Job Overview

Position: Project Manager

Division: Clinical Trials

Employment Type: Full Time - Onsite

Reporting To: Senior Vice President of Operations

Compensation: Based on experience


About Research & Development Institute, Inc.

Research & Development Institute, Inc. operates as a research laboratory and biobank, providing services as a Contract Research Organization for leading In Vitro Diagnostic companies in the sector.

The Project Manager is responsible for the design and execution of IVD sample collection trials at RDI, ensuring that services are delivered within the agreed timelines and budget. This role involves leveraging our extensive network of healthcare professionals and laboratories to achieve optimal client satisfaction. The Project Manager will execute all responsibilities in compliance with RDI's standard operating procedures, Good Clinical Practice guidelines, and relevant regulatory standards.


Key Responsibilities

  • Develop and document a comprehensive project plan detailing each site and laboratory, including site selection, kit distribution, CTMS setup in Salesforce, and logistics.
  • Assess and communicate potential risks, devising strategies to mitigate them.
  • Oversee clinical studies as the Project Owner, ensuring protocol feasibility, team training on project plans, and managing regulatory documentation.
  • Craft protocols for swift IRB approval that align with client specifications while minimizing deviations.
  • Identify and prioritize project tasks on a weekly basis.
  • Ensure team members focus on prioritized tasks, addressing any issues with service providers as necessary.
  • Design case report forms that effectively capture required data, facilitating audits and minimizing errors.
  • Provide clients with options for kit materials and designs.
  • Create training materials for Site Initiation Visits (SIV) to outline study procedures.
  • Conduct or coordinate training for site staff.
  • Manage clinical visits, including site qualifications and closeouts.
  • Ensure timely IRB approvals for all clinical studies and sites.
  • Proactively monitor project progress, addressing issues and client inquiries promptly, which may require flexible working hours.
  • Track and resolve client requests throughout the study lifecycle.
  • Facilitate client calls and visits, ensuring punctuality.
  • Review project requirements against current workloads, recommending additional resources as needed.
  • Ensure timely generation of site payments and client invoices.
  • Review and approve site payments prior to submission.
  • Oversee successful execution of data management activities.
  • Review shipping manifests and the contents of shipping containers.

Qualifications

  • Minimum of 5 years of industry experience, with at least 2 years in clinical study management.
  • Strong knowledge of Good Clinical Practice (GCP) and related procedures.
  • Experience in the in vitro diagnostics or medical device industry.
  • Exceptional organizational, time management, budget management, and problem-solving abilities.
  • Able to thrive in a dynamic, fast-paced environment and adapt to shifting priorities.
  • This position requires onsite presence.

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