Katalyst Healthcares & Life Sciences
Clinical Research Scientist
Katalyst Healthcares & Life Sciences, Summit, New Jersey, us, 07902
Job Description
Title: Clinical Research Scientist Job 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 oncology/hematology data including but not limited to: safety, primary efficacy variables, and laboratory data. Assist with clinical document preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). Assist with clinical study report preparation to include narrative writing. Participate in adhoc meetings. Support clinical trial activities as requested. Skills/Knowledge Required: Minimum 10 years 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 review and interpretation. Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions. Full understanding of 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. Oncology/Hematology experience (required); Registry experience (plus). Protocol authoring (plus). Data review and medical monitoring of data (required). Qualifications: Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 10 years' experience in clinical research development or equivalent.
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Title: Clinical Research Scientist Job 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 oncology/hematology data including but not limited to: safety, primary efficacy variables, and laboratory data. Assist with clinical document preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). Assist with clinical study report preparation to include narrative writing. Participate in adhoc meetings. Support clinical trial activities as requested. Skills/Knowledge Required: Minimum 10 years 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 review and interpretation. Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions. Full understanding of 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. Oncology/Hematology experience (required); Registry experience (plus). Protocol authoring (plus). Data review and medical monitoring of data (required). Qualifications: Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 10 years' experience in clinical research development or equivalent.
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