Clinical Research Scientist (EZIJP00002334)
Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications.
At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources.
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)
- Perform literature search and data analysis to address research questions
- In collaboration with other clinical staff and/or an external CRO, monitor clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.)
- Assist in database cleaning, review of study results, and interpretation of results
- Adhere to key performance indicators for clinical study development, conduct, and reporting
- Individual contributor with specialized knowledge
- Present concepts, facts, and reports and advise on key trends and issues
- Troubleshoot routine site inquiries
- Work is completed under limited supervision
- Support the planning, execution and reporting of clinical programs/trials
- May handle multiple protocols simultaneously
- Contribute to risk resolution by escalating and monitoring project risks
Minimum Qualifications:
- Minimum of 5-7 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) degree preferred
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