Currently hiring for a Compliance Director with a Clinical Research Site Network located in Orlando, FL. This role is fully onsite in Orlando, FL and currently offering a relocation package.
Position Overview
The Compliance Director plays a crucial role in leading the Compliance Team to ensure that all clinical research activities meet the highest standards of regulatory compliance and quality assurance. This role involves overseeing regulatory affairs, source development, data management, quality control, and overall compliance. The Compliance Director will ensure that data collection adheres to ALCOA-C standards and that research activities comply with ICH GCP guidelines, FDA regulations, SOPs, and relevant federal and state regulations.
Key Responsibilities
- Develop, implement, and uphold quality assurance standards to ensure adherence to protocols, data integrity, and patient safety throughout all clinical research activities.
- Design and execute compliance strategies, risk assessments, and key initiatives to enhance overall compliance.
- Collaborate with compliance and clinic teams to maintain continuous “inspection readiness” at all research sites.
- Manage and oversee internal audits, sponsor audits, and FDA inspections, ensuring thorough preparation and follow-up.
- Lead daily operations related to quality control, data collection, regulatory compliance, deviation and SAE tracking, and CAPA (Corrective and Preventative Action) management.
- Supervise the upkeep of all version-controlled documents, including SOPs, Work Instructions, and Forms, ensuring they accurately reflect current operations.
- Provide expert compliance and regulatory guidance to senior leadership and staff. Prepare detailed reports, presentations, and CAPA plans to address compliance gaps and ensure ongoing adherence to regulatory standards.
- Ensure timely reporting of compliance issues to Institutional Review Boards (IRBs), sponsors, and/or Contract Research Organizations (CROs) as needed.
- Analyze deviation trends and develop related training, systems, and SOPs to minimize errors and enhance clinical trial performance.
- Utilize performance metrics to identify areas needing improvement and implement effective process enhancements.
Supervisory Responsibilities
Manage supervisory duties in alignment with company policies and legal requirements, including interviewing, hiring, training, planning, and directing work. Responsibilities also include performance evaluations, coaching, mentoring, and resolving employee issues.
Knowledge, Skills, and Abilities
- Extensive experience with audits by industry sponsors and FDA inspections.
- Strong leadership abilities with a focus on data integrity, quality, and regulatory excellence.
- Excellent analytical, critical thinking, and writing skills with a track record of improving clinical research operations.
- Outstanding communication and presentation skills, capable of representing the company professionally before sponsors, CROs, and FDA inspectors.
- Proven management experience with a successful track record in leading teams and implementing comprehensive compliance plans.
- Exceptional planning, organizational, and multitasking skills with a high level of personal integrity and initiative.
Qualifications
Education: Bachelor’s degree in research administration, healthcare administration, business administration, legal or regulatory studies, biomedical science, or a related field. A Master’s degree in a similar field is preferred.
Certification: Preferred professional research certifications (e.g., CCRC, ACRP-CP, CCRP, CHRC) from respected organizations like ACRP or SOCRA.
Experience:
- Minimum of three years in clinical research compliance, focusing on regulatory, compliance, and quality assurance.
- At least two years of experience in conducting or overseeing audits or inspections.
- Proven success in clinical trials operations or compliance management roles.
- A minimum of three years of team management experience.
