VacatureSenior CRA fase I [ingevuld door Carpe Diem]
Korte omschrijvingVoor een grote, internationale CRO ben ik op zoek naar een (senior) CRA voor de fase I studies (homebased).
BedrijfsprofielMijn klant betreft een grote, internationale CRO met een groot scala aan studies binnen diverse therapeutische indicatiegebieden.
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 2 up to 5 years clinical monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) - Phase I 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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