GCP Clinical Auditor III (Remote US)
$75,000–$115,000 year
RemoteUnited States
Job Summary
Conduct and lead client, internal, and GCP audits, as well as activities supporting regulatory inspections. Provide GCP consultation and quality support to project teams and external clients, while performing database audits, clinical study report audits, and process-improvement initiatives. Prepare comprehensive audit reports for management, present findings at departmental and client meetings, and serve as a subject matter resource on audit and quality assurance topics. Mentor junior auditors and lead directed clinical site and facility audits. This role requires up to 50% travel within the US and international travel, with a standard Mon-Fri schedule. Candidates must be legally authorized to work in the US without sponsorship and pass a comprehensive background check including drug screening.
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 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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