Ocena ogólna pracodawcy
SANACLIS POLAND sp. z o.o.
KRAKÓW, UL. BALICKA 99
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Senior CRA
Balicka 99, Bronowice Małe Wschód, Kraków
Wygasła: 05.03.2022
full-time
umowa o pracę
hybrid work
senior specialist (Senior)
Obowiązki:
- You would be primarily responsible for monitoring clinical trials and:
- Ensuring that clinical trial is conducted, recorded, and reported in accordance with all applicable international and local regulations and guidelines, good practices, SOPs and Clinical Trial Protocol
- Ensuring data quality and integrity meet acceptable clinical standards
- Guaranteeing the rights and safety of patients involved in a study are protected
- Performing and coordinating all aspects of the clinical monitoring and site management process
- Conducting remote and on-site visits to assess protocol and regulatory compliance and managing required documentation
- Developing collaborative relationships with investigational sites, act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects rights, well-being, and data reliability; and you would ensure audit readiness
- Serving as facilitator of Clinical Trial conduct in respective area in terms of identifying qualified sites and investigators, facilitating communication between sponsor and regulatory authorities and trial sites
- Apart from general CRA responsibilities, you would mentor and supervise less experienced colleagues (CRAs and CTAs) and ensure their professional development and quality of their performance
Ogłoszenie Archiwalne
Ogłoszenie Archiwalne
