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Clinical Research Scientist

New Jersey All, NJ

Posted: 01/09/2019 Job Type: Clinical Job Number: JN -012019-23353
  • 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 oncology/hematology data including but not limited to: safety, primary efficacy variables, and laboratory data
  • Assist with clinical document 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
  • Support clinical trial activities as requested
Skills/Knowledge Required:
  • Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 10 years experience in clinical research development or equivalent
  • 3-5 yrs. experience in oncology/hematology clinical development required
  • Excellent written and verbal communication skills and interpersonal skills
  • Knowledge of clinical trial design, basic statistics, and data review tools
  • Proficient at data review and interpretation
  • Full understanding GCP and ICH Guidelines
  • Detail-oriented, well-organized
  • Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview and EDC (Rave)
  • Demonstrated ability to work as part of a team
  • Registry experience (plus)
  • Protocol authoring (plus)
  • Data review and medical monitoring of data (required)
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