Research Compliance Auditor

3 days ago


Edison, New Jersey, United States Hackensack Meridian Health Full time
Job Summary

Hackensack Meridian Health is seeking a highly skilled Research Compliance Auditor to join our team. As a key contributor to our Research Compliance Audit and Monitoring Program, you will be responsible for ensuring compliance with applicable policies, regulations, and best practices.

Key Responsibilities
  • Conduct thorough reviews of research records and activities to ensure compliance with institutional, state, and federal requirements.
  • Prepare reports identifying areas of strength and/or needs improvement.
  • Track and monitor corrective and preventive action (CAPA) plans.
  • Ensure our research teams are audit-ready by performing mock FDA audits.
  • Provide guidance and support to researchers and staff on research compliance matters.
  • Assist in the development and implementation of policies and procedures for compliance with applicable policies and regulations.
  • Prepare annual written reports and metrics for leadership and the Audit and Compliance Committee.
  • Independently conduct assigned research compliance audit work plan items.
  • Stay up-to-date on federal requirements and implications for our research enterprise.
Requirements
  • Bachelor's degree from an accredited college or university in a relevant area of study.
  • Minimum of 7 years of relevant professional experience in research administration and/or conducting research at an institution of higher education and/or academic medical center.
  • Experience working with research administration software solutions.
  • Basic understanding of research regulations and processes in at least one area of research compliance.
  • Strong organization skills, ability to work independently and as part of a team.
  • Excellent written and verbal communication skills, including public speaking.
  • Proficient computer skills, including Microsoft Office and/or Google Suite platforms.
Preferred Qualifications
  • Relevant professional certifications.
  • 5+ years of research audit experience.


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