Roles & Responsibilities
- Review and ensure the accuracy and completeness of medical records, surgical records, protocols, and study data.
- Collaborate with staff to identify, evaluate, and recommend solutions to review and correct findings.
- Draft study deviations in a timely manner and incorporate Study Director impact assessments.
- Perform audits of protocol, SOP, and quality system elements to ensure compliance with GLP regulations and internal procedures.
- Ensure preclinical in-vivo studies are compliant with GLP regulations (21 CFR Part 58) and adhere to internal quality guidelines.
- Identify and report basic non-compliance within regulations and standards.
- Collaborate efficiently with different groups, managing movements between various locations around the site according to stakeholder schedules.
Experience Required
- Preferred : Bachelor’s degree with 3 years of preclinical medical device research experience, or 5 years of relevant work experience supporting preclinical research (, LAR / surgical vet tech).
- Background in data management and familiarity with medical device GLP research.
- Demonstrated understanding in the use of calibrated equipment, controlled drugs, and GLP data collection / retention.
Skills & Certifications
- Excellent attention to detail.
- Strong data management skills.
- Ability to collaborate effectively with various teams and stakeholders.
- Proficiency in adhering to and enforcing compliance with GLP regulations and internal procedures.
Eligibilities & qualifications
- Preferably holds a Bachelor’s degree with 3 years of experience in preclinical medical device research or 5 years of relevant work experience supporting preclinical research.
- Demonstrated understanding of calibrated equipment, controlled drugs, and GLP data collection / retention.
- Must be able to identify basic non-compliance within regulations and standards.
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