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
-- 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)