Job Description

• 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 Seas
• 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. #J-18808-Ljbffr OnPoint Consulting

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