Clinical Research Specialist II, Peds Hematology/Oncology (Hybrid)

Job description

Clinical Research Specialist II, Peds Hematology/Oncology (Hybrid) - ( 25000BJ8 ) Description A Brief Overview Works with the Principal Investigator to coordinate all aspects of implementation of assigned multiple and/or complex clinical research trials. What You Will Do: - Responsible for submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%; Competency 1, 2) - 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). (20%; Competency 1, 2) - Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (10%; Competency 1, 2) - 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. (20%; Competency 1, 2) - Assists with SOP, grant and protocol development and active participant in preparation of manuscrip...