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Clinical Research Monitoring Specialist
3 semanas atrás
This is a role that involves conducting on-site and remote monitoring of clinical research studies. The primary objective is to ensure quality monitoring through the development of tools, procedures, and processes.
Key Responsibilities:- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory compliance and protocol adherence.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
- Minimum of 1 year prior clinical research or monitoring experience.
- Knowledge of Good Clinical Practice and other applicable regulatory requirements.
The ideal candidate will possess excellent analytical and problem-solving skills with the ability to work effectively in a fast-paced environment.
