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Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes. The company's solutions empower life sciences companies to reach diverse populations beyond traditional clinical research methods.
The Quality Assurance Specialist will participate in continuous improvement of the quality system framework by assisting with the creation and execution of quality audit plans, supporting identification and remediation of identified trends, overseeing the vendor management program, and executing computer system validation activities. This position provides daily quality oversight of clinical trial conduct and reports to the Director, Clinical Quality Assurance.
Key responsibilities include:
- Leading and/or participating in client audit preparation, hosting, and follow-up
- Supporting identification and implementation of continuous improvement opportunities and initiatives
- Assisting with development and refinement of SOPs governing clinical and quality operations
- Assisting with creation and execution of internal clinical quality audit plans
- Conducting and participating in internal audits of Science 37 cGXP departments (e.g., Clinical Operations, Nursing Solutions, Medical Affairs)
- Owning and executing the Vendor Management and Quality programs
- Remaining current with regulations and industry best practices in clinical trials
- Participating in Quality Organization improvement projects as required
The first 6 months will be 5 days per week in the Morrisville office. After 6 months, the role transitions to a hybrid schedule: Monday, Wednesday, and Thursday in-office; Tuesday and Friday remote.
REQUIREMENTS:
- Bachelor's degree in science or related field (required)
- 2+ years of experience in clinical research or other GxP environment (required)
- ISO 9001 Lead Auditor Certification (preferred)
- Proven track record of cross-functional collaboration
- Knowledge of cGXP regulations, Quality Management Standards (e.g., ISO 9001), and current industry best practices
- Excellent written and oral communication skills
- Ability to meet deadlines in a fast-paced environment
- Excellent interpersonal skills and ability to understand group dynamics
- Strong organizational skills and ability to adapt to rapidly changing work environment
- Strong creative problem-solving skills and sound judgment
- Ability to provide guidance and structure while encouraging innovation
- Experience developing, implementing, and maintaining electronic quality management systems; direct experience with Compliance Quest desired
- Fluency in English (verbal and written)
