GCP Clinical Auditor II (remote US)
$60,000–$90,000 year
RemoteUnited States
Job Summary
Conduct and lead client, internal, and GCP audits while supporting regulatory inspections and complex system audits. Identify quality and regulatory compliance issues, assess root causes of non-conformance, and develop strategies to address identified risks. Perform technical document reviews, database audits, and clinical study report audits to ensure adherence to global regulatory guidelines and client contractual requirements. Prepare comprehensive audit reports, deliver quality services to external clients, and serve as a key point of contact for audit-related matters. Requires up to 50% travel within the US and internationally.
Required Qualifications
- Bachelor's degree or equivalent relevant formal academic or vocational qualification
- Previous Quality Assurance experience that provides the knowledge, skills, and abilities required to perform the role (comparable to 2-5 years' experience)
- Detailed knowledge of Good Clinical Practice (GCP) and applicable regional clinical research regulations and guidelines
- Demonstrated experience successfully leading a range of project-based and/or internal GCP audits and vendor audits
- Excellent written and verbal communication skills
- Strong problem-solving, risk-assessment, and impact-analysis capabilities
- Solid experience conducting root cause analysis
- Strong negotiation and conflict-management skills
- Ability to work effectively in a dynamic environment, manage multiple priorities, and balance competing demands and workloads
- Valid driver's license and ability to meet applicable company requirements associated with business travel
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, which includes a drug screening
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
- Able to work upright and stationary for typical working hours
- Ability to use and learn standard office equipment and technology with proficiency
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
- Required travel (25-50%)
Desired Qualifications
- Audit experience in a regulated industry (clinical research or pharmaceutical highly preferred)
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