GCP Clinical Auditor II

This is a fully remote position, open to applicants in Texas.

📋 Description

• Lead and execute intricate internal and external audits to ensure compliance with quality assurance processes, standards, regulatory guidelines, and client contractual obligations.

• Detect quality and regulatory compliance challenges, evaluate the root causes of non-conformance, and formulate strategies to mitigate risks.

• Perform technical document evaluations and engage in other Good Clinical Practice activities that support clinical projects and organizational processes.

• Conduct and/or oversee client, internal, GCP, clinical site, facility, process, database, and clinical study report audits.

• Assist during regulatory inspections and serve as a co-auditor on complex system audits.

• Offer GCP consultation and quality support to project teams and external clients.

• Act as a resource for operational teams regarding audit and quality assurance topics.

• Prepare, share, and present audit findings and quality-related information in departmental, internal operations, and client meetings.

• Compile detailed audit reports for management and act as the main point of contact for clients on quality and audit issues.

⛳️ Requirements

• Bachelor's degree or an equivalent relevant formal academic or vocational qualification.

• 2–5 years of prior experience in Quality Assurance.

• Experience in auditing within a regulated industry; clinical research or pharmaceutical experience is highly preferred.

• In-depth knowledge of Good Clinical Practice (GCP) and relevant regional clinical research regulations and guidelines.

• Proven experience in leading project-based and/or internal GCP audits as well as vendor audits.

• Exceptional written and verbal communication skills.

• Strong abilities in problem-solving, risk assessment, and impact analysis.

• Solid experience in conducting root cause analysis.

• Strong skills in negotiation and conflict management.

• Capacity to work effectively in a dynamic environment, manage multiple priorities, and balance competing demands and workloads.

• Willingness to travel as required, including up to 50% within the US and potentially internationally.

• Valid driver's license and ability to meet the company's requirements for business travel.

• Ability to communicate, receive, and comprehend information and ideas clearly with diverse groups.

• Capability to work upright and stationary for typical hours.

• Proficient in using and learning standard office equipment and technology.

• Ability to perform well under pressure while managing multiple projects or activities.

• Must be legally authorized to work in the United States without sponsorship.

• Must successfully pass a comprehensive background check, including drug screening.

🏝️ Benefits

• Home-based/fully remote work.

• Variable annual bonus eligibility based on company, team, and/or individual performance.

• Reasonable accommodation for individuals with disabilities.

• Relocation assistance is NOT provided.