Senior Clinical Research Associate - Czech Republic
Nr ref.: /JOBS.pl
Due to several business wins, they are expanding their clinical teams across the business. There really is no better time to join them.
Furthermore my client boasts structured training courses in place so you can develop your career with an exciting company.
Depending on experience responsibilities 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
Experience Typically required :
* Experience of clinical research monitoring including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment
* In lieu of the above requirements, candidates significant previous experience 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
* 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
This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be. Please contact Sayful Islam on (O) or email a CV to .com.
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