Clinical Quality Auditor – Clinical Research

Job Description: • 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. Requirements: • 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. Benefits: • Medical, dental, and vision insurance for the individual employee and family • 401K Retirement Plan with generous company matching • Disability Insurance, 100% paid • Life Insurance, 100% paid • Paid Approved Training and ACRP Certification • Paid Licensure Renewal • 9 Paid Holidays • 3+ Weeks Paid Time Off • Bereavement Leave • And more!