Research Clinical Scientist
Randstad is seeking a Research Clinical Scientist for a temporary assignment at one of its biotechnology clients. 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.
- 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 recommendation 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
- 1-5 years experience post-M.S. without thesis. Industrial experience preferred.
- 0-3 years experience post M.S. with thesis. Industrial experience preferred.
- Ph.D. with no post-doctoral research experience
Regulatory Affairs Certification (RAC) helpful but not required.
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law. San Francisco Fair Chance Ordinance: Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.