Temporary Clinical Scientist (20-18547)
Job Description
Clinical Scientist – Summit, NJ
Responsibilities will include, but are not limited to, the following:
1.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.
2.Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data.
3.Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
4.Assist with Study Start up Activities and data base build
5.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
How to Apply
Please send your updated resume to iris.chen@axelon.com284 total views, 0 today