Senior Clinical Research Associate

Responsibilities

• 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

• 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

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