Vacancy expired!
CLINICAL SCIENTIST WITH HEMATOLOGY / ONCOLOGYSUMMIT, NJPosition anticipates returning to the site in September.Project Description:
- 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 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 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/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 Google Cloud Platform 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), Review, 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).
- Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years' experience in clinical research development or equivalent.
Vacancy expired!