Title: Clinical Research Scientist
Duration: 12 Months (Possibility of Extension)
Location Woodcliff lake NJ
Job Responsibilities:
- The incumbent is responsible for, but not limited to the following:
- Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies
- Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc)
- Performs literature search and data analysis to address research questions
- In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
- Assisting in database cleaning, review of study results, and interpretation of results
- Adhering to key performance indicators for clinical study development, conduct, and reporting
- Individual contributor with specialized knowledge
- Presents concepts, facts, and reports and advises on key trends and issues
- Troubleshooting routine site inquiries
- Work is completed under limited supervision
- Supports the planning, execution and reporting of clinical programs/trials
- May handle multiple protocols simultaneously
- Contributes to risk resolution by escalating and monitoring project risks