[Hiring] Clinical Quality Auditor @Flourish Research

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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.