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Go from coordinator to clinical research professional: risk based monitoring, CRA skills, data management to database lock, and pharmacovigilance.
8 modules · 48 lessons
Advanced GCP and quality systems, clinical monitoring and the CRA role, risk based monitoring and trial oversight, site management recruitment and project delivery, a minor project running a full monitoring engagement, clinical data management and biostatistics, pharmacovigilance safety and regulatory submissions, and a major project managing a complete study lifecycle.
Level up from coordinator to clinical research professional. This intermediate program from Ucanly takes practitioners with working knowledge of ICH GCP, trial design, informed consent, source documentation, and site operations into professional monitoring and data management: advanced GCP quality systems, CAPA methodology, and the Clinical Research Associate role across SIV, IMV, and COV visit types. You will master risk based monitoring, building oversight plans with defined key risk indicators and centralized statistical signal detection, and in your minor project in week five, run a complete monitoring engagement including source data verification, a findings report, and a CAPA plan. You will build clinical data management skills through database lock, CDISC CDASH and SDTM standards, and biostatistics fundamentals, then move into pharmacovigilance with MedDRA coding, SUSAR reporting, and regulatory submissions including the eCTD. You will graduate having managed a complete study lifecycle in your week ten major project as both a Clinical Research Associate and data professional, covering startup, risk based monitoring across sites, data management to database lock, safety case processing, inspection readiness, and a clinical study report contribution. All studies, subjects, and data used in this program are entirely simulated, and this program teaches ethical, compliant clinical research practice only.
Complete this course to earn a verified Ucanly certificate you can add to your profile, share on LinkedIn, and showcase to employers as proof of the skills you've built.
It is recommended, but working knowledge of ICH GCP, trial design, informed consent, source documentation, and site operations is sufficient to start.
No, all studies, subjects, and data used in this program are entirely simulated. This program teaches ethical, compliant clinical research practice only, and never substitutes for regulatory or medical judgement.
Yes, you will build skills as both a Clinical Research Associate running risk based monitoring and a data professional managing databases to lock, including pharmacovigilance and regulatory submissions.
A full study lifecycle managed as a Clinical Research Associate and data professional, covering startup, risk based monitoring across sites, data management to database lock, safety case processing, inspection readiness, and a clinical study report contribution.