Research Functions Participates in pre-study and site initiation activities Initiates and manages all phases of clinical trials Provides technical assistance to study sites regarding the conduct of clinical research Monitors clinical and/or laboratory data to ensure accuracy, thoroughness, and regulatory compliance of clinical documentation Reviews new and ongoing studies Screens, recruits, educates, and obtains consent from subjects for participation in studies Maintains patient enrollment and screening logs Obtains medical records as necessary and compiles subjects’ medical history Ensures subject compliance with research protocol Schedules monitoring visits Conducts and documents clinic visits per protocol Reviews concomitant medication during each clinic visit Ensures drug accountability Directs patient care Completes follow-up visit logs for data entry Resolves queries and completes data clarification forms Completes and submits case report forms/Electronic Data Capture (EDC) Conducts lab processing and shipment Updates physician on subject study participation, completion, abnormal test results, etc. Notifies subjects of test results and progress Nursing Functions Administer medications in accordance with the protocol as allowed within scope of practice Administer scales and provide assessments as allowed within scope of practice Assess patient response to treatment and communicate with care team as appropriate Gather medical histories and reconcile concomitant medications Administrative Functions Corresponds with the institutional review board as necessary Keeps the principal investigator/sub-investigator informed of the progress on assigned protocols Serves as liaison for the study. Tracks the data forms, reports, and documents necessary for completion of the clinical study. Performs clinical safety monitoring throughout the trial Reviews safety reports and routes to appropriate trial personnel Oversees delivery and shipment of trial products, maintains drug and study supply inventories Maintains regulatory binders Reviews the work of research assistants and related staff Other Functions Attends meetings and participates on committees as necessary Reviews current literature and attends training sessions and seminars to keep informed of new developments in the field Performs other related duties and responsibilities as directed