Title: Clinical Research Scientist - III Location: Parsippany NJ Duration: 12+ Months Pay Range: $110/hr - $117.5/hr
" Acquires and utilizes knowledge of clinical trial design to develop specific study concept sheets and protocols.
" Participates in protocol review discussions concerning scientific and procedural aspects of study design.
" Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed with appropriate guidance and supervision.
" With supervision, contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
" With supervision, addresses questions regarding scientific and related procedural issues from Investigators.
" With supervision, contributes to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations.
" Assists in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
" Supports priorities within functional area. Anticipates moderately complex obstacles within a clinical study and with guidance implements solutions.
" May be asked to coordinate teams and provide direction.
" May lead two or more specific components of departmental strategic initiatives.
" Must be able to enter a new therapeutic area and summarize scientific information that is available in published literature to integrate into new study development.
" Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
" 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
MS with 6+ years relevant scientific and/or drug development experience.
BS or RN with 8+ years relevant scientific and/or drug development experience