Research Clinical Scientist 2
Randstad is seeking a Research Clinical Scientist for a contract assignment at one of its biotechnology clients in San Diego, CA. This client is a leading developer, manufacturer, and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood, and aid in biomedical research. You will work in an atmosphere that is stimulating, innovative, and customer focused.
- Work with the Assay Development, Clinical Affairs, and Regulatory Affairs teams to develop background and discussion language for regulatory documents, including researching and writing of data summaries and meta-analyses.
- Critically review scientific publications, regulatory documents, clinical plans, clinical study protocols and reports, integrated summaries, and responses to regulatory agencies. Prepare reports for the sub-project in support of the overall project.
- Work with team members to ensure integrity of scientific data by assisting in the development of data collection/review/analysis materials.
- Provide scientific guidance to team members while study is active and review data to identify and investigate discrepant results or issues.
Working hours: 8:00 AM - 5:00 PM
- Working knowledge of statistics to apply and understand appropriate study design and data analysis for clinical trials.
- Familiarity with methods for review and summary of published scientific literature.
- Familiarity with different clinical study designs for IVD devices.
- Familiarity with basic FDA regulations related to clinical trials for IVD devices.
- M.S. Molecular Biology, Chemistry, Biochemistry or related field.
- Ph.D. Molecular Biology, Chemistry, Biochemistry or related field
- 5-7 years experience post-M.S. without thesis. Industrial experience preferred.
- 4-6 years experience post M.S. with thesis. Industrial experience preferred.
- Ph.D. with post-doctoral research experience. Industrial experience preferred.
- Ph.D. with no post-doctoral research experience or 2-3 years industrial experience.
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