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
Qualifications
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
Additional Information
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!