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Clinical Research Scientist
3 months ago
Description:
- Acts as Lead Data Reviewer for internal studies and works with Study Directors to ensure adequate and timely data review for all aspects of GLP and Preclinical Functionality studies including but not limited to medical records, surgical records, protocols, and study data.
- Collaborates with staff to identify, evaluate, and recommend solutions to review and correct findings.
- Drafts timely study deviations and incorporates Study Director impact assessment.
- Responsible for performing audits of protocol, SOP, and quality system elements to ensure preclinical in-vivo studies comply with the GLP regulations (21 CFR Part 58) and internal procedures. Adheres to internal quality guidelines.
- Complies with regulations and standards. Identifies basic non-compliance within regulations and standards.
- Requires excellent attention to detail, a background in data management, and familiarity with medical device GLP research.
- Requires ability to collaborate among different groups, moving between various locations around the site efficiently and in cooperation with stakeholder schedules.
Qualification:
- Bachelors degree with 3 years of preclinical medical device research experience or 5 years of relevant work experience supporting preclinical research (LAR/surgical vet tech).
- Demonstrated understanding in the use of calibrated equipment, controlled drugs, GLP data collection/retention.
