CRAII \ Senior Clinical Research Associate

Reference No: J7722

CRAII / Senior Clinical Research Associate
Permanent / Home based
Competitive Salary

Company Information
Working for a leading global CRO in a field based capacity working on numerous sites across the Netherlands.

Role
•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

Candidate Criteria
•2 to 4 years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits)
•In lieu of the above requirements, candidates with three (3) years of site management and/or study co-ordinator experience will be considered
•Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines
•Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
•Fluency in English plus local language(s)
•Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process
•Good planning, organization and problem solving abilities
•Good communication and interpersonal skills
•Available for travel up to 60% of the time, including overnight stays as necessary

Education
University/college degree (life science preferred), or certification in a related allied health profession (e.g. nursing certification, medical or laboratory technology).
Alternatively, candidates with two or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered as well.

If this role sounds like it would be ideal for you, please call Natalie Kennedy on 0044 2078221710
Or please email – natalie.kennedy@clinicalprofessionals.eu

Key words
CRA, Clinical, Research, Associate, Monitoring, SCRA, Netherlands

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