Overview:
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.
Responsibilities:
What you will be doing:
* Perform all type of visits from site feasibility to close out visits according to plan, document actions and follow up on action plans
* Train and guide site staff in safety information handling, systems, protocol and trial procedures to minimize protocol deviations
* Proactive use of EDC and other data source systems for preparation and conduct on site visits as well as source data verification in collaboration with data management/logistics team
* Identify potential risks and proactively take action to prevent or mitigate
* Collaborate with Data Management/logistics in resolving queries
* Assist to ensure data cleaning cycle timelines are met in accordance with the Data Flow Plan
* Motivate and build strong relations with site personnel to assist the sponsor in being their preferred clinical research partner
* Collaborate with and provide oversight of deliverables from vendors locally, if applicable
* Support the site in filing and archiving trial documentation in the Investigator Trial Master File (ITMF)
* Participate in Investigators Meetings to ensure relations with sites as well as active presentation as applicable
* Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements
* Support audits and inspections at sites and affiliate, as applicable
Qualifications:
You are:
*
* Bachelor or Master's degree in life sciences or other relevant fields.
* At least 3 years of experience as a Clinical Research Associate.
* Therapeutic area knowledge and demonstrating an understanding of oncology, diabetes, psychiatric, neurology, cardiology studies or similar is an advantage.
* Excellent knowledge of Clinical Trial Management Systems, Good Clinical Practices and Trial Management.
* Strong analytical and communication skills with business, industry understanding and stakeholder management.
* Fluent in English.
* Valid driver's license
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