Job Number: 21345338
- 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.
- Potentially assume study lead responsibilities, manage study, work independently.
- Participate or lead in Scientific meetings (i.E., Ad-Board, Steering Committee, Data Monitoring Committee).
- Multi-tasking, i.E working on multiple studies and/or multiple deliverables.
- Advanced Degree in Life Sciences (e.G., nursing, pharmacy, or related medical field), minimum 5 years' experience in clinical research development or equivalent.
- 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 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), J-Review, EDC (Rave).
- Demonstrated ability to work as part of a team.
- Hematology experience (plus).
- Protocol authoring is preferred.
- Data review and medical monitoring of data.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02320
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE