Senior Clinical Research Associate

* 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.Qualifications

* 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment.* 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.Additional Information

All your information will be kept confidential according to EEO guidelines.

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