Clinical Monitoring
In detail…
Develop and coordinate all aspects of clinical monitoring and site management process, in accordance with ICH-GCP, FDA standards, local regulations and client internal procedures.
Lead site visits to ensure compliance with both protocol and local and international regulations, in addition to handling essential documentation in optimal conditions.
Responsible for ensuring that data meet quality requirements for local and international audits and inspections. Developing supportive and collaborative relationships with participating research centers.
Preparation and delivery of monitoring reports at each visit to the research centers, in order to keep a record of observations and findings made at each visit, in addition to ensuring traceability during the life cycle of the clinical study.