Clinical Research Scientist - III

An American biotechnology company that develops cancer immunotherapy products with a primary focus on genetically engineered autologous CAR T cell therapy — a cell-based therapy which relies on chimeric antigen receptors and T cells.

About the role

Established in 2000, VARITE is an award-winning minority business enterprise providing global consulting and staffing services to Fortune 1000 companies and government agencies. This is a 12-month contract position with potential for conversion following the term, depending on business needs.

Location: Remote (EST or PST). Schedule is flexible but generally 9:00–17:00 in the supported time zone.

Pay rate: $110.00–$118.34/hr on W2. Work authorization: U.S. Citizen or Green Card only.

Responsibilities

• Acquire and utilize knowledge of clinical trial design to develop specific study concept sheets and protocols.
• Participate in protocol review discussions concerning scientific and procedural aspects of study design.
• Prepare study protocols, amendments, specific sections of study manuals, Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision.
• With supervision, contribute to the design and development of CRFs, Data Management Manuals, and Data Analysis Plans.
• With supervision, address questions regarding scientific and related procedural issues from Investigators.
• With supervision, contribute to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
• Assist in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures, and NDAs.
• Support priorities within functional area; anticipate moderately complex obstacles within a clinical study and, with guidance, implement solutions.
• May coordinate teams and provide direction.
• May lead two or more specific components of departmental strategic initiatives.
• Enter a new therapeutic area and summarize scientific information available in published literature to integrate into new study development.
• Maintain working relationships with team members to ensure scientific integrity of clinical studies through excellent verbal and written communication and interpersonal skills.
• May be sought out for advice by others within the company to help make better decisions and resolve moderately complex problems.

Requirements

• PharmD with 2+ years relevant scientific and/or drug development experience, or
• MS with 6+ years’ relevant scientific and/or drug development experience, or
• BS or RN with 8+ years’ relevant scientific and/or drug development experience.

Benefits

We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:

• Health Insurance: Medical, dental, and vision coverage.
• Retirement Plans: Participation in a company-sponsored retirement savings plan.
• Legal Service Plans: Access to attorneys for legal advice and representation.