Clinical Trials Compliance Specialist

2 days ago


Oklahoma City, Oklahoma, United States The University of Oklahoma Full time

The University of Oklahoma is seeking a highly skilled Clinical Trials Compliance Manager to join our team at the Stephenson Cancer Center.

This is a unique opportunity to work in a highly competitive and accredited environment, ensuring the highest standard of care for our patients.

The Clinical Trials Compliance Manager will be responsible for auditing site-specific and affiliate clinical trials, as well as investigator-initiated studies, to ensure compliance with federal, sponsor, and internal guidelines.

This role will involve monitoring protocol compliance, discussing deviations with management, and recommending process changes to enhance data quality.

The Clinical Trials Compliance Manager will also collaborate with informatics and database analysts to ensure compliance with HIPAA requirements.

Key Responsibilities:

  • Conduct audits of site-specific and affiliate clinical trials to ensure compliance with federal, sponsor, and internal guidelines.
  • Develop and implement Standard Operating Procedures (SOPs) for site auditing and informatics.
  • Monitor protocol compliance and identify non-compliance issues.
  • Discuss deviations with management and recommend process changes to enhance data quality.
  • Ensure compliance with HIPAA requirements.
  • Represent the site as point-of-contact for external auditors.
  • Perform systematic internal audits to enhance data quality and prepare for external audits.
  • Train and prepare staff for external audits.
  • Implement standard operating policies and procedures for research record organization and storage.
  • Develop site-specific operational policies and procedures to ensure site compliance with CFR guidelines.
  • Perform training and educational programs to ensure clinical research staff are trained in compliance with CFR quality guidelines.
  • Supervise auditing and informatics staff.
  • Evaluate recommendations and action plans from external audits and implement changes.

Requirements:

  • Strong knowledge of federal, sponsor, and internal guidelines for clinical trials.
  • Excellent auditing and compliance skills.
  • Ability to work independently and as part of a team.
  • Strong communication and interpersonal skills.
  • Ability to analyze data and identify non-compliance issues.
  • Experience with HIPAA requirements.


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