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Scientific. Clinical. Software Engineering

Clinical Research Scientist

New Jersey All, NJ

Job Type: Clinical Job Number: JN -042020-26640 Region: New Jersey All

Job Description

  • Review and query of hematology data including but not limited to: eligibility criteria, primary efficacy variables, pathology, anti-MM therapies, and laboratory data
  • Coordinate with contract research organization (CRO) and liaise with clinical sites for timely data completion
  • Actively manage clinical sites to ensure study timelines are adhered
  • Assist the Clinical Research Scientist team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Regulatory and Project Management
  • Support with clinical study report preparation
  • 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)
  • 2-3+ yrs. experience in oncology/hematology clinical science/development
  • Knowledge of clinical trial design, basic statistics, and data review tools
  • Proficient at data review and interpretation
  • Experience in protocol development and regulatory submissions
  • Full understanding GCP and ICH Guidelines
  • Ability to assimilate technical and scientific information quickly
  • Excellent written and verbal communication skills and interpersonal skills
  • 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
  • Oncology/Hematology experience
  • Data review and medical monitoring of data
  • Protocol authoring experience

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