Clinical Trials Coordinator

2 weeks ago


San Mateo, California, United States ACL Digital Full time

Position: Clinical Trial Associate

Location: Remote

Duration: Long-term Contract

Overview:

The Clinical Operations team is pivotal in executing Phase I - IV clinical trials across various therapeutic areas. This role is integral in ensuring that all clinical studies are conducted in compliance with established protocols, regulatory standards, and company policies, thereby generating high-quality clinical data essential for the successful registration and commercialization of products.

Key Responsibilities:

  • Act as the primary operational contact for biomarker and bioanalytical strategies, collaborating with both internal and external stakeholders.
  • Participate in various clinical study teams, contributing to the planning and coordination of operational activities related to biological specimen management.
  • Ensure the collection of biological samples adheres to ethical standards and is of high quality for analysis.
  • Serve as the main liaison between study management teams and laboratory vendors, overseeing day-to-day operations to meet project objectives.
  • Critically assess scientific proposals and protocols, providing insights into clinical operational feasibility.
  • Foster strong cross-functional relationships, demonstrating leadership in coordinating with various teams to ensure effective execution of biomarker strategies.
  • Identify potential operational challenges proactively and collaborate with senior team members to develop resolution plans.
  • Organize and lead operational meetings with study teams and vendors to ensure alignment and progress.
  • Maintain comprehensive databases and document repositories related to biomarker and bioanalytical operations.
  • Review and interpret study documents, ensuring clarity and compliance with protocol requirements.
  • Contribute to the development of Requests for Proposals (RFPs) and assist in the selection of contract research organizations (CROs) and vendors.
  • Participate in special projects as needed, contributing to the overall efficiency and effectiveness of clinical operations.

Qualifications:

We seek candidates with diverse backgrounds and experiences to enhance our team:

  • Advanced degree in life sciences with relevant clinical experience.
  • Proven ability to adapt quickly to changing environments and manage multiple projects effectively.
  • Strong understanding of clinical study management best practices and regulatory requirements.
  • Familiarity with medical and scientific terminology.

This role is designed for individuals who are committed to excellence in clinical research and are eager to contribute to the advancement of healthcare solutions.



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