Job Details

  • Title: Scientist, Clinical Research - NJ
  • Code: RCI-9826
  • Location: Lawrenceville New Jersey (NJ) 08648
  • Posted Date: 09/28/2020
  • Duration: 12 Months
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  Job Description

Position Responsibilities

  • Review clinical data from ongoing studies to ensure scientific quality
  • Develop Protocol and ICF documents / amendments
  • Conduct literature review
  • Submit clinical documents to TMF
  • Develop site and CRA training materials
  • Review clinical narratives
  • Monitor clinical data for specific trends
  • Review protocol deviations and contribute to Protocol Deviation Assessment Plan
  • Develop Data Review Plan in collaboration with Data Management
  • Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
  • Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
  • Seek out and enact best practices with instruction
  • Provide regular and timely updates to manager/management as requested

Degree Requirements

  • Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry)

Experience Requirements

  • Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
  • Ability to understand assigned protocol(s) and their requirements
  • Basic knowledge skills to support program-specific data review and trend identification
  • Intermediate medical writing skills and medical terminology
  • Basic planning/project management skills (develop short range plans that are realistic and effective)

Key Competency Requirements

  • Detail-oriented with commitment to quality
  • Basic knowledge of disease area, compound, current clinical landscape
  • Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
  • Intermediate critical thinking and problem-solving skills
  • Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
  • Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)