Summit, New Jersey
Posted on: July 15, 2021
Industry: Scientists / Research / Lab Technician
Job Number: JN -072021-67094
Responsibilities will include:
- 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 haematology/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 Study Start up Activities and data base build.
- Participate or lead in Scientific meetings (i.e. Ad-Board, Steering Committee, Data Monitoring Committee)
- Potentially assume study lead responsibilities, manage study, work independently
- multi-tasking, i.e. working on multiple studies and/or multiple deliverables.
- Minimum 6 yrs. experience in oncology/haematology 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.
- Haematology experience (plus). Protocol authoring (preferred).
- Data review and medical monitoring of data (required).
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