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Posted 116 months ago

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Clinical Research Scientist

Summit, NJ, United StatesRemoteFull-time

AI Summary

A Clinical Research Scientist supports the Clinical Research team by reviewing hematology/oncology data, assisting with protocol authoring and study report preparation, and ensuring compliance with GCP/ICH guidelines.

About this role

Clinical Research Scientist

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity.

To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com

CORE JOB RESPONSIBILITIES:

  • 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 adhoc meetings

Qualifications

KNOWLEDGE/SKILLS/ABILITIES (KSA's):

  • Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years’ 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 REQUIRED.
  • Minimum 5 yrs 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, 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


Additional Information

All your information will be kept confidential according to EEO guidelines.

IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP!

I look forward to hearing from you!

Skills

Basic StatisticsClinical Trial DesignData InterpretationData ReviewGCPHematologyICH GuidelinesInvestigator Brochure PreparationJReviewMicrosoft OfficeMicrosoft ProjectOncologyProtocol DevelopmentRave EDCStudy Report Preparation

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