Senior Clinical Research Associate, Netherlands - Home based

Senior Clinical Research Associate, Permanent, Netherlands - Home based

Clinical research organisation based in the Netherlands seeks Senior Clinical Research Associate to oversee all aspects of new clinical trials.
Duties:
*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
Experience/Skills required:
*University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
*Alternatively, candidates with extensive relevant clinical research experience in pharmaceutical or CRO industries will be considered.
*Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
*Thorough understanding of the drug development process
*Thorough knowledge of appropriate S.O.P.s regarding site monitoring
*Valid drivers' license
*Extensive experience of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits)
*Fluency in English and Dutch essential.
*Candidates with similar experience in clinical research are invited to apply as well
*Have a full understanding of Serious Adverse Events (SAEs): process production of reports, narratives and follow up of SAEs
*Excellent site monitoring and site management skills
*Ability to work with minimal supervision
*Good computer skills with good working knowledge of a range of computer packages
*Ability to work within a project team
*Available for travel
Fantastic package available for the right candidate, great opportunities for career progression and very flexible working arrangements.

Please send your CV to [Email hidden] to apply
1st IT People Limited is acting as an Employment Agency and/or Employment Business