VacatureSenior CRA oncologie [ingevuld door Carpe Diem]
Korte omschrijvingVoor een grote, internationale farmaceut ben ik op zoek naar een (senior) CRA met ervaring in oncologie.
BedrijfsprofielMijn klant betreft een grote, internationale farmaceut met een groot scala aan studies binnen diverse therapeutische indicatiegebieden. Momenteel zoeken ze vooral versterking binnen de oncologie.
Functie omschrijvingResponsibilities include:
* all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties
* all aspects of site and registry management as prescribed in the project plans
* Organize and make presentations at Investigator Meetings
* Report, write narratives and follow-up on serious adverse events
* Review progress of projects and initiate appropriate actions to achieve target objectives
* You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required
* Participate in the development of protocols and Case Report Forms as assigned
* Interact with internal work groups to evaluate needs, resources and timelines
Functie eisen° A minimum of 4 years clinical monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) - oncology experience would be a plus
° University/college degree (life science preferred), or certification in a related allied health profession (e.g. nursing certification, medical or laboratory technology).
• Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
• A full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
• Fluency in English and local language
• Good communication, planning, organization and problem solving skills

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