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Compliance Director

2 months ago

Orlando, Florida, United States Charter Research Full time
Job Summary

We are seeking a highly experienced Compliance Director to lead our Clinical Research Operations team at Charter Research. As a key member of our organization, you will be responsible for ensuring the highest standards of compliance and regulatory excellence in all our clinical research activities.

Key Responsibilities
  • Develop and implement quality assurance standards and practices to ensure adherence to protocols, data integrity, and patient safety.
  • Design and implement compliance plans, risk analyses, and key compliance initiatives to mitigate risks and ensure regulatory compliance.
  • Oversee internal audits, sponsor audits, and FDA inspections to ensure our research studies and clinical processes meet the highest standards.
  • Lead the execution of day-to-day activities for quality control checks, data collection, regulatory requirements, deviation and SAE tracking, and CAPA tracking and follow-up.
  • Manage all version-controlled documents, including SOPs, Work Instructions, and Forms, to ensure they are up-to-date and reflect our operations.
  • Provide compliance and regulatory guidance and direction to senior site leadership and staff.
  • Prepare presentations, reports, policies, and CAPA plans to address gaps and findings to ensure compliance and regulatory standards are continuously met.
  • Ensure timely reporting of compliance issues to Institutional Review Boards (IRBs), sponsors, and/or Contract Research Organizations (CROs), if required.
  • Analyze deviation trends and guide the development, planning, and implementation of related trainings, systems, and SOPs to reduce or eliminate errors in the performance of clinical trials.
  • Utilize quality performance metrics to identify areas of low performance and implement process improvements.
Requirements
  • Bachelor's degree in research administration, healthcare administration, business administration, legal or regulatory studies, biomedical, science, or another research-related field.
  • Master's degree preferred in research administration, healthcare administration, business administration, legal or regulatory studies, biomedical, science, or another research-related field.
  • CCRC, ACRP-CP, CCRP, CHRC, or another professional research certification strongly preferred.
  • Extensive clinical trials experience, including at least three (3) years of clinical research compliance-related responsibilities and at least two (2) years of experience conducting or overseeing internal audits or inspections of research studies or processes.
  • Proven record of accomplishments in a clinical trials operations or compliance management role.
  • At least three (3) years of experience managing a team.