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!

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

GCP auditsclinical quality auditingCAPA developmentroot cause analysisStandard Operating Proceduresquality metrics analysisrisk mitigationvendor qualificationcompliance gap identificationaudit planning

Soft Skills

organizational skillsattention to detailwritten communicationverbal communicationprocess buildingstakeholder influencecritical thinkingrisk assessmentproblem-solvingprofessionalism