Clinical Research Compliance Supervisor

2 weeks ago

Newport Beach, California, United States DB Healthcare, Inc. Full time
Position Overview

Role: Clinical Research Compliance Supervisor

Company: DB Healthcare, Inc.

Description:

The Clinical Research Compliance Supervisor position is essential for overseeing the operational aspects of clinical research within the organization. This role is pivotal in upholding regulatory standards and ensuring that all activities align with the company's mission and strategic goals.

Key Responsibilities:
  • Conduct clinical research in accordance with established industry standards and best practices.
  • Ensure that projects are in line with the organization’s objectives and meet stakeholder expectations.
  • Facilitate the approval process for study start-ups and maintain comprehensive regulatory compliance documentation throughout research initiatives involving human subjects.
  • Ensure adherence to regulatory requirements across all research studies and maintain precise regulatory files.
  • Serve as a primary resource for team members regarding regulatory matters.
  • Oversee daily regulatory operations, ensuring tasks are executed accurately and efficiently.
  • Collaborate closely with team members to ensure compliance with study protocols.
  • Manage the informed consent process, ensuring compliance with institutional language requirements.
  • Work alongside legal partners and sponsors to ensure uniformity in consent agreements.
  • Implement and maintain an organized system for planning and executing research activities while ensuring compliance with Good Clinical Practice.
  • Stay informed about federal, state, and local regulations, communicating updates to the research team.
  • Coordinate with the Director of Clinical Research - Finance & Regulatory.
  • Authorize new submissions to the Institutional Review Board (IRB).
  • Monitor the protocol approval process and develop solutions to enhance approval timelines.
  • Register and maintain clinical trials on appropriate platforms and systems.
  • Update the clinical trial management system within the department as necessary.
  • Maintain the Institution's Federal Wide Assurance for compliance purposes.
  • Assist in the development, writing, and updating of Standard Operating Procedures (SOPs) and related documentation.
  • Perform additional duties as assigned.
Requirements:
  • A minimum of 5 years of experience in Clinical Research.
  • Familiarity with FDA, Medicare, and insurance guidelines pertaining to clinical trials.
  • Understanding of clinical research protocols and internal SOPs.
  • Excellent communication and organizational skills.
Educational Background:
  • High School diploma or equivalent required.
  • Bachelor's Degree preferred.

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