CRA

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

• The CRA is responsible for the initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
• Frontline liaison between the sponsor and sites to ensure successful collaboration, meeting sponsor's expectation on milestone and deliverables with true ownership mindset
• Manages assigned study sites, conducting phase I-IV protocols according to the monitring plan and sponsor's procedures,
• Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects
• Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
• Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including
• Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study tea
• Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
• Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at sites
• Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
• Collaborates with internal stakeholders and site personnel to manage data query resolution process and to ensure timely and accurate data entry
• Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date. 

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• Universtity Degree
• Ability to travel nationally with overnight stays
• Experience conducting all types of MVs such as: Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
• A demonstrated working knowledge of ICH/GCP Guidelines
• Excellent record-keeping skills and attention to detail
• Fluent in English and local language- both written and orall