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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.
Job Responsibility:
Site Support & Oversight: Manage site-level communications, coordinate site trainings and systems access, and support site readiness activities including pre/post site visit tasks, and follow-up on action items
Document Management: Maintain Trial Master File (TMF) and Investigator Site File (ISF) accuracy and inspection readiness
perform quality control, filing, and tracking of essential documents in partnership with CTM, CRAs and TMF Lead as applicable
Data & System Management: Support subject tracking, data entry oversight, and system maintenance in CTMS and eTMF
assist with eCRF UAT testing and clinical sample tracking
Compliance & Audit Readiness: Prepare for and support audits/inspections, support CAPA implementation, and ensure adherence to protocol, GCP, and regulatory requirements
Monitoring & Issue Resolution: Ensure data entry timeliness, speedy query resolution, support CRA’s with protocol deviations follow-ups, and site escalations
support SAE and external data submissions and follow up
Site Relationship Management: Support the CRA in establishing and maintaining strong site relationships. CSA needs to understand site-specific processes, and act as a back-up point of contact for the CRA
or as a primary point of contact when needed
Demonstrates technical proficiency in clinical trial technologies, including electronic data capture (EDC) systems, clinical trial management systems (CTMS), and remote monitoring tools to streamline trial operations and ensure data integrity
Monitors key risks and alerts CRA and/or site when risk flags as concerning
Regulatory & Safety Support: Assist with safety reporting submissions, serious breach reporting, and due diligence checks for institutional/staff changes
May be required to travel <10% of time domestically
Requirements:
Bachelor's degree in a relevant field, such as life sciences or healthcare
Previous experience in clinical research or a related field preferred
Strong organizational and communication skills
Ability to work independently and collaboratively in a fast-paced environment
Attention to detail and ability to prioritize tasks effectively
Fluent in English and local language, with good verbal and written communication skills
What we offer:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others