Compliance Director

3 days ago

Orlando, Florida, United States Charter Research Full time
Job Title: Compliance Director

Charter Research is seeking a highly experienced Compliance Director to lead our Compliance Team and ensure the highest standards of regulatory compliance and quality assurance in our clinical research operations.

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.
  • Collaborate with compliance and clinic teams to ensure "inspection readiness" across all sites at all times.
  • Oversee internal audits, sponsor audits, and FDA inspections of selected research studies and/or clinical processes.
  • Plan and 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.
  • Oversee the management of all version-controlled documents, including SOPs, Work Instructions, and Forms, ensuring they are kept up to date and reflect the operations of the company.
  • Provide compliance and regulatory guidance and direction to senior site leadership and staff.
  • Prepare presentations, reports, policies, and Corrective and Preventative Action (CAPA) plans to address gaps and findings to ensure compliance and regulatory standards are continuously met.
  • Ensure the 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.
  • At least three (3) years of clinical trials experience, including compliance-related responsibilities, regulatory, compliance, and/or quality assurance.
  • 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.
What We Offer:

Charter Research provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability status, genetic information, marital status, ancestry, protected veteran status, or any other characteristic protected by applicable federal, state, and local laws.

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