QA Manager - Clinical Research
Location: San Diego, CA (Fully On-Site)
Salary: $100,000 - $110,000 per year plus benefits
Hours: Monday - Friday, 8:30 AM – 5:00 PM
Format: Contract-to-hire, 6 months
Position Overview
The QA Manager will join a high-volume oncology research site in San Diego to support the expansion of compliance programs. Reporting to the Assistant Director of Quality Assurance, this role is critical in ensuring the integrity of clinical trial data and the safety of research participants.
Key Responsibilities:
- Conduct systematic reviews and audits of investigator-initiated and industry-sponsored oncology clinical trials to ensure compliance with protocol, Good Clinical Practice (GCP), and federal regulations.
- Review subject research records, including informed consent, eligibility, dose modifications, and adverse event reporting.
- Utilize and manage data within systems such as Velos, Epic, and Florence to ensure accuracy and data integrity.
- Serve as a resource for clinical and regulatory staff, providing professional and constructive feedback to resolve compliance issues without a "gotcha" mentality.
- Assist in the analysis of Serious Adverse Events (SAEs) and provide guidance on the necessary elements for safety reports to ensure protocol compliance.
- Develop written audit reports summarizing findings, deviations, and discrepancies for presentation to the Data Safety and Monitoring Committee (DSMC).
- Interact frequently with investigators and internal departments to ensure trial activities are completed with the highest quality.
- Advise investigators and protocol writers on structuring studies to minimize protocol violations.
Requirements:
- A Bachelor’s degree in a related area is required.
- At least 2 years of experience in clinical trial research, regulatory affairs, or data management.
- Ability to navigate and utilize clinical trial auditing tools and large patient databases.
- Extreme precision and the ability to spot discrepancies in complex medical and regulatory documentation.
- Exceptional interpersonal skills with the ability to deliver feedback in a professional and educational fashion.
- Previous experience in an oncology research setting is highly preferred.
- Prior experience as a Quality Assurance professional, Clinical Research Associate (CRA), or Auditor is a significant advantage.
