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Network Director Clinical Research Quality Assurance

Company: The START Center for Cancer Care
Location: San Antonio
Posted on: September 24, 2022

Job Description:

Job Details

Job Location
START - Phase I - San Antonio, TX

Position Type
Full Time

Education Level
4 Year Degree

Job Shift

Job Category
QA - Quality Control

The Clinical Research Quality Assurance Director (QAD) ensures that all START Clinical Research sites comply with internal standard operating procedures, Good Clinical Practice, and federal regulations. The QAD develops in collaboration with other departments continuous quality review process and internal audit processes. The Clinical Research Quality Assurance director reports directly to START Audit and Compliance Committee and to the VP Business Development and Strategy. The QAD works in close collaboration with Physician leadership, nursing leadership, and the START executive team to build and implement the Quality Management system (QMS) and reporting platforms.

Tasks and Responsibilities:

  • Review and update Network Standard Operating Procedures (SOPs) for all START clinical research personnel; ensure ongoing compliance and SOP review across all network sites;
  • Develop and implement quality monitoring system (QMS) to demonstrate full compliance with internal SOPs, IRB protocols, federal and state regulatory agencies;
  • Lead internal auditing activities to identify and mitigate areas of potential risk, and promote preparedness for external audit;
  • Develop quality reporting calendar and dashboard to routinely report START network clinical research quality indicators and foster continuous process improvement;
  • Develop and deploy necessary training and education to support compliance with internal quality standards;
  • Collaborate with other research department leaders to identify and address areas for process improvement;
  • Support special projects requiring QA input, including staff training;
  • Assist with management of contract auditors and monitors;
  • Other duties as required.

    Background REQUIREMENTS:
    • Bachelors degree required, clinical degree preferred;
    • Previous experience in audit / monitoring for oncology clinical research preferred;
    • Knowledge of GCP, GDPR and federal clinical research regulations required in US and Europe;
    • Process improvement or Quality Management certification preferred (e.g. LEAN, Six Sigma);
    • Must be familiar with Microsoft Office applications and clinical documentation systems.

Keywords: The START Center for Cancer Care, San Antonio , Network Director Clinical Research Quality Assurance, Healthcare , San Antonio, Texas

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