Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We are actively hiring a Clinical Quality Auditor to join our Central Quality team. This is a critical remote position that supports investigator sites and vendors across the organization. The Clinical Quality Auditor plays a critical role in ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and Flourish Research Standard Operating Procedures while supporting continuous improvement initiatives across the organization. • Plan, conduct, and report GCP audits including investigator site, vendor, and internal audits to ensure adherence to regulatory requirements, study protocols, monitoring plans, and Flourish Research SOPs. • Support execution of the annual Quality Assurance audit plan and ensure timely completion of audit activities. • Maintain audit and inspection readiness across assigned sites and vendors. • Support and participate in regulatory inspections, including FDA and other health authority inspections. • Assist with inspection hosting, response coordination, and follow-up corrective actions. • Serve as a quality and compliance advisor to site leadership, study teams, and cross-functional partners. • Identify compliance gaps, risks, and trends; support root cause analysis and CAPA development. • Contribute to the development, review, and continuous improvement of SOPs and quality processes. • Support vendor qualification, oversight, and ongoing compliance activities. • Analyze audit findings and quality metrics to support risk mitigation and continuous improvement initiatives. • Maintain clear and professional communication with leadership, site teams, vendors, and internal stakeholders. • Represent Flourish Research with professionalism and integrity in all interactions. • Perform additional duties as assigned by management. Qualifications • Bachelor’s degree preferred or equivalent relevant experience. • Approximately five years of experience in clinical quality auditing or GCP compliance within a clinical research environment; exceptions may be considered for strong candidates with fewer years who demonstrate a strong quality and compliance mindset. • Investigator site audit experience required. • Vendor audit and vendor compliance experience required. • Strong working knowledge of ICH, FDA, and GCP regulations. • Experience planning and executing audits, CAPAs, and root cause analysis. • Experience writing, reviewing, and improving Standard Operating Procedures. • Excellent organizational skills and attention to detail. • Excellent written and verbal communication skills. • Ability to build processes, influence stakeholders, and contribute to the growth of the quality function. • Strong critical thinking, risk assessment, and problem-solving skills. • Proficiency with computers and Microsoft Office Suite. Requirements • Remote - strong preference for East Coast-based candidates. • Travel: 30-50% with potential to trend toward the higher end. • Shift: Monday-Friday, Normal business hours (occasional evenings or weekends as needed). • Compensation: $80,000-$93,000 annually + discretionary bonus. Benefits • Health, dental, and vision insurance plans. • 401(k) with 4% match. • Tuition reimbursement. • Parental leave. • Referral program. • Employee assistance program. • Life insurance. • Disability insurance. • 15 days of PTO + 10 company holidays. Apply tot his job