What are the responsibilities and job description for the Principal Clinical Scientist position at Genabio Diagnostics?
Responsibilities
- Conducting site selection and qualification, Negotiating budget and contract with clinical sites.
- Leading the development of clinical study protocol and reports.
- Collaborating with Regulatory to prepare FDA pre-submission and submission packages.
- Overseeing clinical sites, central lab, and other third parties to ensure issues are resolved timely.
- Overseeing the clinical studies to ensure target timeline and budget are met.
Education and Experience
- A bachelor’s degree or equivalent in a life sciences, nursing, or related discipline. Advance degree preferred.
- Minimum 10 years of clinical research experience for medical device and IVD products. Minimum 5 years’ experience with rapid self-test IVD products is required.
- Experience in communicating with the FDA.