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Clinical Scientist

New Jersey All, New Jersey

Post Date: 01/06/2017 Job ID: JN -012017-18055 Industry: Clinical Scientist - Clinical
  • Assist the Clinical Research 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 clinical study report preparation to include narrative writing
  • Participate in ad-hoc meetings
Skills:
  • Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field)
  • Minimum 5 years of experience in clinical research development or equivalent
  • Oncology experience required
  • Hematology experience is a plus
  • Protocol authoring is a plus
  • Data review and medical monitoring of data is required
  • Minimum 5 years of experience in Oncology 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 and 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), etc.
  • Demonstrated ability to work as part of a team


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