Allucent je svetovalni in zdravstveni partner, ki malim in srednje velikim biotehnološkim podjetjem pomaga razvijati terapije skozi proces razvoja zdravil. Njegove storitve vključujejo klinični razvoj, klinično farmakologijo, regulativno strategijo, varnost zdravil in farmakovigilanco ter podpirajo programe od zgodnjih raziskav in kliničnih preskušanj do spremljanja po prihodu zdravila na trg. Z več kot 30 leti izkušenj in strokovnega znanja na področjih, kot so onkologija, nalezljive bolezni, nevrologija, avtoimunska stanja in redke bolezni, Allucent biotehnološkim ekipam pomaga reševati znanstvene, regulativne in operativne izzive pri uvajanju novih zdravljenj na trg.
Senior Clinical Research Associate, Contractor
Monitor clinical trials and manage investigator sites as a contractor with Allucent. Support regulatory affairs, site activation, and compliant study start-up.
Opis
- Oversee monitoring for assigned clinical trials, from site initiation through routine visits and close-out.
- Maintain compliance with study protocols, GCP, ICH, SOPs, and applicable regulations.
- Build strong site relationships, serve as a primary contact, and support high-quality data collection.
- Resolve site issues and escalate concerns to protect trial integrity and patient safety.
- Support regulatory affairs, site activation, and study start-up activities.
- Travel throughout Israel.
Zahteve
- At least five years of experience leading monitoring activities in complex trials; oncology or rare disease experience is preferred.
- Strong knowledge of ICH-GCP and regulatory guidance.
- Confident communication skills in English and the local language.
- Ability to work independently and manage competing priorities.
- Willingness to travel as required.