1. Monitors, evaluates and analyzes laboratory results on a daily basis, excluding weekends and holidays, from sponsor designated central laboratory using sponsor-designated data management system. Laboratory safety parameters are monitored for each patient at every site throughout clinical drug trial.
2. Conducts preliminary review of laboratory results relative to established protocol-specific reference range guidelines, using relevant clinical laboratory experience.
3. Follows established procedure for comparing current results with prior laboratory values to evaluate or note potentially clinically significant increases/decreases, contacts the investigator site for pertinent additional clinical assessment, consults with the Sponsor/Quintiles physicians for medical evaluation of case as needed.
4. If applicable, reviews and evaluates retest results, initiates contact with investigative site if appropriate.
5. Composes telephone contact reports documenting site contact that includes all clinically relevant information. Distributes according to scheme designated at project inception.
6. Responsible for training, serving as mentor and assisting in supervision of other Medical Services staff within the department.