Sr CRA in oncology - Kalyanino
Только для зарегистрированных пользователей Kalyanino, Россия
1 месяц назад
Job summary
Sr CRA in oncology - Sponsor dedicated - Home Based - Denmark
Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
- 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.
Qualifications
- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Preferably oncology experience.
Описание работы
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