Clinical Research Scientist

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

KNOWLEDGE/SKILLS/ABILITIES (KSA's):

• 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)
• Demonstrated ability to work as part of a team

All your information will be kept confidential according to EEO guidelines.

IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP!

I look forward to hearing from you!