Job Details

  • Title: Clinical Scientist
  • Code: RCI-43361-1
  • Location: Summit, New Jersey 07901 (Temporary Remote)
  • Posted Date: 11/24/2021
  • Duration: 6 Months
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  Job Description

Job Description:

Remote until site is reopened

Must haves:

  • 2+ years of experience working on clinical trials
  • Previous role as a Clinical Scientist, or Clinical Manager/Study Lead
  • Experience with writing study protocols
  • Experience with clinical trial data review and cleaning
  • Advanced Science degree (or additional years of experience if no advanced Science degree) 

The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.

  • Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
  • May serve as Clinical Trial Lead for one or more trials
  • May lead or support trial level activities for one or more trials with the necessary supervision
  • May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members
  • Collaborate and liaise with external partners (e.g., KOLs)
  • Seek out and enact best practices with instruction
  • Provide regular and timely updates to manager/management as requested
  • Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
  • Conduct literature review
  • Submit clinical documents to TMF
  • Develop site and CRA training materials and present these at SIVs and Investigator meetings
  • Review clinical narratives
  • Monitor clinical data for specific trends
  • 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.)