Clinical Research Scientist (EZIJP00002334)

Artech LLC.; Woodcliff Lake (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading staffing company is seeking a Clinical Research Scientist to support the planning and execution of clinical studies. Candidates should have 5-7 years of experience in clinical research, preferably in the pharmaceutical industry, and knowledge of GCP. A Bachelor's degree is required; a Doctoral degree is preferred. The role involves monitoring clinical trials, preparing documents, and analyzing data. This is a contract position located in Woodcliff Lake, New Jersey.

Qualifications

• 5-7 years of clinical research experience in the pharmaceutical industry.
• Thorough understanding of study design and protocol writing.
• Knowledge of GCP and local regulatory requirements.

Responsibilities

• Assist in planning and managing Phase I-III clinical studies.
• Prepare and review project and study documents.
• Monitor clinical trial conduct and handle safety issues.

Skills

Clinical research methodology

Data analysis

Protocol writing

GCP knowledge

Oncology research techniques

Education

Bachelor's degree

Doctoral degree (PharmD or PhD)

Job description

Clinical Research Scientist (EZIJP00002334)

Contract

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.

Responsibilities

• 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
• Present 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 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