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Key Responsibilities:
- Support the Quality Management System including SOPs, training, and CAPA processes.
- Host client/sponsor audits and support regulatory inspections.
- Coordinate and conduct vendor, internal, investigator site, and trial master file audits.
Qualifications:
- Extensive working knowledge of GCP Process Audits.
- Bachelor's degree in science, healthcare, or related field.
- Availability to travel up to 25% domestically and/or internationally.
Preferred Experience:
- CRO experience and QA certification (e.g., CQA, SQA) preferred.
- Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO).
Precision for Medicine
Precision for Medicine is a Clinical Research Organisation that combines novel clinical trial designs with advanced biomarker and data analytics solutions. The company has a strong focus on rare diseases and oncology, with a global team and a culture that values employee contributions and collaboration.