Clinical Research Monitor

JOB SUMMARY

The ​Clinical Research Monitor​ensures compliance of the clinical research with the currently approved protocol/amendment(s), with all applicable regulatory policies and guidelines, including Good Clinical Practice (GCP), as well as with Sidra’s policies and procedures. S/he assists in the design, development, implementation, and conduct of an effective monitoring program in accordance with GCP, institutional policies and procedures, and research protocols.

As such, the clinical research monitor performs a quality control measure to ensure the integrity of research data and protection of the rights and well-being of study participants.

The ​Clinical Research Monitor​ should monitor all study related procedures and documentation such as Informed Consent Form, Source Documentation and CRF review, Adverse Events, Serious Adverse Events and Unanticipated Problems, Investigational Product (IP) (if applicable), Laboratory and Specimen Management, Protocol Deviations/Violations, Investigator Site File (ISF) / Study binder, Roles and Responsibilities of site staff, Facilities appropriate to study execution and Enrollment target, recruitment strategies

The ​Clinical Research Monitor​ ensures that, for those clinical research studies assigned for monitoring, the appropriate and required monitoring tasks and related activities occur as outlined in the monitoring plan or as per the procedure “Monitoring for clinical research and clinical trials” and in compliance with all related regulatory standards. S/he monitors if the reported study data is accurate, complete, and verifiable from source documents, and captures all inconsistencies observed during the clinical research studies in order to prevent recurrence on non-compliance with established regulatory standards.

The ​Clinical Research Monitor​ is responsible for multiple projects at a time, and must have strong time management skills in addition to working both independently and in a team environment.