Monitoring of Clinical Trials.

Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.

Member of clinical research team conducting DVT clinical trials. Reviewed eCRFs for completeness, clarity, legibility, consistency, conformity to available source documentation, and adherence to protocol requirements. Identified deficiencies and discrepancies and provided remedial correction action as required per SOPs, protocol, ICH/GCP guidelines and regulations.

• Senior CRA at Kendle Int.• Contract CRA at Dimensional Health Care Inc.• CRA at Kriger Research Center • Science Professor, lecturer at Southern Ontario College• Senior CRA at Biostart Ltd• Scientific Researcher at State Medical University

Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while continuing to develop knowledge of the drug development process, Good Clinical Practices, and relevant regulations. Provides clinical and technical support for CRA I, CRA II and administrative staff. Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs).

Member of clinical research team conducting diabetes clinical trials etc.

Member of clinical research team conducting oncology, dermatology and diabetes clinical trials.