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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

Reporting To: SVP of Operations

Compensation: Based on experience


About Research & Development Institute, Inc.

Research & Development Institute, Inc. operates as a leading research laboratory and biobank, functioning as a Contract Research Organization for major In Vitro Diagnostic firms within the industry.

The Project Manager is responsible for the design and execution of IVD sample collection trials at RDI, ensuring that all contracted services are delivered punctually and within budgetary constraints. Utilizing our extensive network of healthcare professionals and laboratories, the Project Manager aims to achieve high levels of client satisfaction while adhering to 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 specifics such as site selection, kit distribution per site, CTMS setup in Salesforce, and logistics for lab operations and shipping.
  • Assess and communicate potential risks, formulating strategies to mitigate them effectively.
  • Oversee clinical studies as the Project Owner for all assigned projects, ensuring feasibility of protocols and study designs, training the team on project plans, and managing regulatory documentation.
  • Quickly design protocols for IRB approval that align with client specifications, minimize unnecessary deviations, and maintain flexibility for both RDI and clients.
  • Identify and prioritize key projects on a weekly basis, ensuring team alignment with these priorities and addressing any issues that arise.
  • Ensure case report forms are designed to capture necessary client data, facilitating audits and minimizing errors from clinical staff.
  • Provide clients with options regarding kit materials and design.
  • Create training materials for Site Initiation Visits (SIV) to clearly outline study procedures.
  • Conduct or ensure comprehensive training for all relevant site personnel.
  • Facilitate clinical visits, including site qualifications, SIVs, and site closures.
  • Guarantee that all clinical studies and sites receive IRB approval promptly for new submissions.
  • Proactively monitor project progress, addressing issues, risks, and client inquiries in a timely manner, which may require flexibility in work hours.
  • Track and resolve client requests throughout the study duration.
  • Conduct timely client calls and host client visits and audits.
  • Review project requirements against current workloads, recommending additional resources or reprioritization as necessary.
  • Ensure Clinical Research Associates (CRAs) generate site payments and client invoices on a monthly basis.
  • Review and approve site payments before submission.
  • Oversee the successful execution of data management activities, including eCRF, manifests, and test files.
  • Review shipping manifests and the contents of shipping containers.

Qualifications

  • Minimum of 5 years of experience in the industry, with at least 2 years in clinical study management.
  • Familiarity with good clinical research practices (GCP) and relevant procedures.
  • Experience in the in vitro diagnostics and/or medical device sectors.
  • Strong organizational, time management, budget management, and problem-solving abilities.
  • Able to thrive in a fast-paced, small company environment and adapt workload based on shifting priorities.
  • This position requires onsite presence.
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