Clinical Validation Coordinator
1 week ago
Role & responsibilities
- Plan and execute clinical validation studies, including protocol development, data collection, and analysis.
- Coordinate with hospitals/clinicians for clinical simulation, usability, and in-hospital evaluations.
- Supporting on preparation of Clinical Evaluation Report, clinical validation report for regulatory submission
- Prepare informed consent forms, patient-facing materials, and study documentation.
- Collect user feedback and clinical observations and assist in documentation for risk analysis and product improvement.
- Analyze clinical feedback and translate it into product improvements or risk mitigations.
- Support post-market clinical follow-up (PMCF) and post-market surveillance (PMS) data collection.
- Assist in root cause analysis and CAPA related to clinical issues.
Preferred candidate profile
- Bachelors or master degree in Nursing.
- 2–4 years of experience in a hospital, ICU, NICU, or medical device clinical environment.
- Good understanding of medical devices, patient care, and hospital workflows.
- Ability to interact with clinicians and observe medical procedures professionally.
- Basic knowledge of study documentation and ethical requirements (GCP awareness is a plus).
- Good written and verbal communication skills for reporting and coordination.
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