Research Analyst

• Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials
• Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files
• Performs all activities related to clinical research studies including but not limited to: screening participants for eligibility and recruitment, obtains informed consent
• Educates participants regarding study requirements and completes case report forms (CRF)
• Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines
• Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies
• Assists with SOP, grant and protocol development
• Active participant in preparation of manuscripts and presentations for scientific meetings
• Establish and maintain communications with Investigator, Sponsor and internal constituents
• Mentorship of the clinical research process to the junior clinical research staff
• Performs other related duties as assigned or required

Clinical Research Specialist II, Peds Hematology/Oncology

Senior Economic Research Analyst