Clinical Research Scientist
This is a 1-year remote contract role that can support EST or PST time zones.
About the role
Develop clinical study concept sheets and protocols based on clinical trial design principles. Participate in protocol review discussions covering scientific and procedural aspects of study design. Prepare study protocols, amendments, study manuals, Investigator meeting materials, and related clinical documents. Contribute to the design and development of Case Report Forms (CRFs), Data Management Manuals, and Data Analysis Plans. Address scientific and procedural inquiries from clinical investigators under guidance. Support preparation and review of data listings, summary tables, study results, manuscripts, and scientific presentations. Assist with regulatory documentation, including IND annual reports, IND safety reports, Investigator Brochures, and NDAs. Identify and resolve moderately complex clinical study issues and support study-related strategic initiatives. Evaluate published scientific literature and synthesize findings to support new study development and therapeutic-area expansion.
Requirements
- PharmD with 2+ years of relevant scientific and/or drug development experience
- MS with 6+ years of relevant scientific and/or drug development experience
- BS or RN with 8+ years of relevant scientific and/or drug development experience
Skills
Required
- Clinical trial design and study development
- Clinical study protocol development and amendments
- Case Report Form (CRF) development
- Data Management Manual development
- Data Analysis Plan development
- Clinical data listings and summary table review
- Investigator Brochure and IND documentation
- IND annual and safety reporting
- New Drug Application (NDA) documentation
- Scientific literature review and therapeutic-area research
- Drug development processes
- Clinical study scientific and procedural review
Preferred
- Experience developing study manuals and Investigator meeting materials
- Experience supporting clinical study manuscripts and scientific presentations
- Experience coordinating clinical study components or strategic initiatives
- Experience working across multiple therapeutic areas
- Experience interpreting clinical study data and integrating scientific findings into study development
Pay
$118.35/hour