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!
Apply Now
Apply Now
• 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!
Apply Now
Apply Now