Clinical Quality Auditor - Clinical Research

Flourish Research

4d•$80,000 - $93,000•Remote

About The Position

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. 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. The Clinical Quality Auditor is responsible for planning, conducting, and reporting investigator site, vendor, and internal audits in accordance with SOPs, FDA and ICH regulations, GCP guidelines, and applicable study requirements. This role reports directly to the Vice President of Quality Assurance and Compliance and works closely with Clinical Operations, Operational Quality, Training, Business Process Management, and other cross-functional partners.

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.

Responsibilities

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.