
Clinical Quality Assurance Specialist
2 days ago
Job Summary:
Quality Assurance ProfessionalWe are seeking a skilled Quality Assurance professional to provide day-to-day clinical quality assurance support across ongoing clinical trials. This individual will play a key role in guiding study teams, maintaining compliance with Good Clinical Practice (GCP), and ensuring quality oversight.
- This is a full-time contract role offering consistent work with 30–40 hours per week.
The successful candidate will be responsible for:
- Serving as the primary QA support resource for clinical study teams, ensuring compliance with GCP and internal quality standards.
- Providing QA expertise during study calls, including protocol deviation meetings, risk-based quality management discussions, study operations, and trial oversight meetings.
- Writing, reviewing, updating, and formatting standard operating procedures (SOPs) and other quality documentation.
- Managing and tracking quality processes within Veeva QMS, including document control, training, and CAPA management.
- Addressing QA-related questions from study teams in real time, providing clear and actionable guidance.
- Supporting inspection readiness and contributing to continuous improvement of QA systems and processes.
- Partnering with cross-functional stakeholders to align on quality expectations and risk mitigation.
To be successful in this role, you will need:
- A Bachelor's degree in life sciences, healthcare, or related discipline.
- 5+ years of Clinical Quality Assurance experience with a strong foundation in GCP.
- Prior experience supporting clinical study teams in a QA capacity.
- Hands-on experience with Veeva QMS.
- Proficiency in MS Office (Excel, PowerPoint, Word).
- Skilled in technical writing, SOP drafting, and document formatting.
- Excellent communication and interpersonal skills.
- Strong organizational skills with the ability to work independently.
This opportunity offers a chance to work in a dynamic environment, where you can make a significant impact on the quality of clinical trials. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply.
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