Description:
This role is responsible for ensuring end-to-end quality oversight of clinical trials, including data integrity, patient safety, regulatory compliance, and audit readiness. You will work closely with Clinical Operations, QA, and Regulatory teams to drive compliance with ICH-GCP, FDA regulations, and sponsor protocols.
Key Responsibilities
1. Quality Assurance & Oversight
- Perform independent quality reviews of clinical trial activities, documentation, and systems
- Ensure compliance with ICH-GCP, FDA regulations, sponsor protocols, and SOPs
- Maintain continuous inspection readiness across studies and systems
- Identify compliance risks and lead root cause analysis and CAPA development
2. Data Integrity & Quality Review
- Conduct QA review of source documents and EDC data within defined timelines (3–5 days)
- Verify accuracy, completeness, and consistency between source, EDC, and supporting records
- Identify trends, recurring issues, and systemic gaps impacting data quality
3. Patient Safety Oversight (QA Perspective)
- Perform independent review of safety data (labs, EKGs, AEs/SAEs) for completeness and proper documentation
- Ensure investigator oversight and timely review/sign-off of safety-related data
- Escalate unresolved safety or compliance risks to senior leadership
4. Audit & Inspection Readiness
- Support and lead internal audits, mock inspections, and quality assessments
- Prepare for and support Sponsor, CRO, and FDA inspections
- Track audit findings, ensure timely resolution, and verify effectiveness of CAPAs
5. Regulatory Documentation & Systems Compliance
- Oversee completeness and quality of Investigator Site Files (ISF/eISF) and essential documents (e.g., DOA logs, FDA Form 1572)
- Ensure document control, versioning, and audit trails meet regulatory standards
- Review and monitor compliance within Shared Investigator Platforms and document systems
6. Quality Systems & Continuous Improvement
- Contribute to development and maintenance of SOPs, QA processes, and quality frameworks
- Maintain training compliance and support GCP/ICH training oversight
- Analyze quality metrics and drive process improvements and standardization
7. Cross-Functional Quality Collaboration
- Partner with Clinical Operations, Data Management, and Regulatory teams to address quality issues
- Provide QA guidance and feedback without direct involvement in study execution
- Support a strong quality culture and inspection mindset across teams
Skills & Systems
- Experience with EDC systems (e.g., Medidata Rave, Oracle Inform, or similar) from a QA review perspective
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook)
- Familiarity with Shared Investigator Platforms/eISF systems (e.g., Veeva Vault, Florence eBinders)
- Experience with CTMS/CTM systems for oversight, tracking, and quality metrics
- Strong expertise in audit readiness, CAPA management, and documentation review
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, or related field (Master’s preferred)
- 3–6 years of experience in Clinical QA, Quality Compliance, or GCP auditing
- Strong knowledge of ICH-GCP, FDA regulations, and inspection processes
- Demonstrated experience in audits, CAPA, and quality systems management
- High attention to detail with strong analytical and problem-solving skills
- Excellent written and verbal communication skills