Job Details

  • Title: Clinical Scientist
  • Code: RCI-1120-1
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 11/20/2020
  • Duration: 6 Months
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  Job Description

  • Assist the Clinical Research Scientist team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
  • Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data.
  • Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
  • Assist with Study Start up Activities and data base build
  • Participate or lead in Scientific meetings (ie Ad-Board, Steering Committee, Data Monitoring Committee)

 

Skills/Knowledge Required:

  • Minimum 6 yrs. experience in oncology/hematology clinical development
  • Excellent written and verbal communication skills and interpersonal skills.
  • Knowledge of clinical trial design, basic statistics, and data review tools
  • Proficient at data interpretation
  • Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
  • Full understanding GCP and ICH Guidelines
  • Detail-oriented, well-organized
  • Ability to assimilate technical and scientific information quickly
  • Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave)
  • Demonstrated ability to work as part of a team
  • Hematology experience (plus).
  • Protocol authoring (preferred).
  • Data review and medical monitoring of data (required).

 

Qualifications:

  • Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field),
  • Minimum 5 years’ experience in clinical research development or equivalent