Title: Clinical Quality Assurance Specialist
This Position Reports to: Director of Quality Assurance
Job Type: Part-time, Contract
Position Overview:
We are a small, fast-paced, growing, and evolving research and development life science company and a leader in our field of Fluorescence Guided Surgery. Everyone at NXDC is driven and passionate about our mission to help cancer patients worldwide receive the best possible care. Your expertise and hard work are needed, valued and rewarded at NXDC. We look forward to learning more about you and how you can add value to our team.
The Clinical Quality Assurance (CQA) Specialist is responsible for providing independent quality oversight of clinical development activities to ensure compliance with applicable regulations, including 21 CFR Parts 312 and 314, ICH E6 (GCP), and internal quality standards. This role supports the clinical quality aspects of the development program through audit activities, TMF oversight, vendor quality management, inspection readiness, and continuous improvement initiatives.
The CQA Specialist partners closely with Clinical Operations and cross-functional teams to ensure quality systems and processes effectively support clinical trial execution.
Responsibilities:
Clinical Quality Oversight
- Provide independent GCP quality oversight for clinical trials in accordance with ICH E6, 21 CFR 312, 21 CFR 314, and other applicable global regulations.
- Support the clinical quality aspects of the development program across all phases of clinical research.
- Ensure alignment between NXDC Quality Systems and Clinical Operations processes.
- Provides quality oversight of safety reporting processes, including SAE documentation, AE consistency, and interface with PVG as applicable.
Trial Master File (TMF) Oversight
- Provide quality oversight of the Trial Master File (TMF), including periodic completeness and quality reviews.
- Collaborate with Clinical Operations to identify gaps and support TMF remediation activities.
- Contribute to TMF inspection readiness efforts.
Audits, CAPAs, and Inspections
- Plan, conduct, and/or oversee clinical site audits, vendor audits, and internal GCP audits.
- Review, classify, and oversee Corrective and Preventive Actions (CAPAs) resulting from audits and inspections.
- Support FDA, regulatory authority, and partner inspections, including preparation, execution, and follow-up activities.
Vendor Quality Management
- Support vendor qualification, risk assessment, and ongoing quality oversight of CROs and other clinical service provides throughout the vendor lifecycle including vendor audits when needed.
- Monitor vendor performance and compliance with contractual and regulatory requirements.
Quality Systems and Metrics
- Work closely with NXDC’s Quality department to maintain and administer the electronic Quality Management System including SOPs, training records, deviations, CAPAs, and change control.[SD1]
- Prepare and report on clinical quality metrics, analyze trends, and support management review.
- Perform quality trending across clinical and non-clinical activities to drive continuous improvement.
Required
- Bachelor’s degree in life sciences or a related discipline.
- Experience in Clinical Quality Assurance, Clinical Operations, or a related GCP-regulated role with working knowledge of 21 CFR 312, 21 CFR 314, ICH E6 (GCP), and FDA inspection processes.
- Experience with clinical audits, TMF oversight, CAPA management, and electronic quality management systems.
- Ability to work independently while collaborating cross-functionally.
- Advanced proficiency in Microsoft Office (Excel, Word, Outlook).
- Strong organizational skills with the ability to manage multiple priorities in a regulated environment.
- Excellent written and verbal communication skills, with strong attention to detail
Job Types: Part-time, Contract
Pay: $60.00 - $70.00 per hour
Experience:
- Clinical Audits: 5 years (Required)
- Clinical Quality Assurance: 5 years (Required)
Work Location: Remote
