Yavor Bonev

Background

About Yavor Bonev

Responsible for management and internal quality monitoring on the progress of clinical studies conducted at Medical Center Hera, and also for ensuring studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. • Facilitates and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines • Assesses the qualification of potential clinical trials at the investigative site, instructs site personnel on the initiation, proper conduct and close out of clinical trials at the investigative site • Reviews and verifies internally accuracy of clinical trial data collected, either onsite or remotely • Provides regular site status information to CROs, Sponsors, and updates internal trial management tools • Completes internal quality monitoring as required by SOPs or other contractual obligations • Works closely with other site staff members to facilitate timely resolution of trial and/or clinical issues • Escalates site and trial related issues per SOPs, until identified issues are resolved or closed • Performs internally essential document site file reconciliation according to site SOPs • Assesses internal IP accountability, dispensation, storage and compliance • Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines • Creates internal study-specific worksheets according to site SOPs • Updates applicable site tracking systems on a regular basis • Ensures all required site training is completed and documented • Serves as observation visit leader • Facilitates audits and audit resolution Therapeutic Experience: Neurology, Pulmonology, Gastroenterology, Psychiatry, Cardiology, Pediatrics.