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Clinical Research Scientist
Ref No.: 17-00188
Location: Woodcliff Lake, New Jersey
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, Client, 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
• Minimum of 2-5 years of experience in clinical research in the pharmaceutical industry
• A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements
• Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred
• Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area;
• Bachelor's Required. Doctoral (PharmD or PhD) or MD degree preferred