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Clinical Project Coordinator

2 months ago

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

Position: Project Manager

Division: Clinical Trials Division

Employment Type: Full Time - Onsite

Reports to: SVP of Operations

Compensation: Based on experience


About Research & Development Institute, Inc.

Research & Development Institute, Inc. is a leading research laboratory and biobank that operates as a Contract Research Organization (CRO) for major In Vitro Diagnostic companies in the field.

The Project Manager is responsible for designing and implementing IVD sample collection trials at RDI, ensuring that services are delivered within the agreed timelines and budget constraints. This role requires collaboration with our network of healthcare professionals and laboratories to achieve optimal client satisfaction. The Project Manager will adhere to RDI's standard operating procedures, Good Clinical Practice (GCP) guidelines, and all relevant regulatory standards.


Key Responsibilities

  • Develop and document comprehensive project plans detailing site-specific requirements, including site selection, kit distribution, CTMS setup in Salesforce, and logistics.
  • Assess and communicate potential risks, devising strategies to mitigate them effectively.
  • Oversee clinical studies as the Project Owner, ensuring protocol feasibility, training the team on project plans, and managing regulatory documentation.
  • Design protocols for swift IRB approval that align with client needs while minimizing deviations.
  • Identify and prioritize key projects on a weekly basis, ensuring team alignment with these priorities.
  • Ensure case report forms capture necessary client data, facilitating audits and minimizing errors.
  • Provide clients with options for kit materials and designs.
  • Create training materials for Site Initiation Visits (SIV) to clarify study procedures.
  • Conduct training sessions for site staff and oversee clinical visits, including site qualifications and closeouts.
  • Ensure timely IRB approvals for all clinical studies and sites.
  • Monitor project progress proactively, addressing issues and client inquiries promptly, which may require flexible working hours.
  • Manage client requests throughout the study lifecycle.
  • Facilitate client meetings and audits, ensuring timely attendance.
  • Evaluate project requirements against current workloads, recommending additional resources as necessary.
  • Ensure accurate site payments and client invoicing on a monthly basis.
  • Review and approve site payments prior to submission.
  • Oversee data management activities, ensuring successful execution.
  • 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 research practices (GCP) and related procedures.
  • Experience in the in vitro diagnostics or medical device sectors.
  • 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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