IHCRA

As a In House CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Participates in the coordination and execution of complex clinical trials, leveraging expertise to ensure adherence to protocol and stringent regulatory requirements throughout all phases of the study lifecycle, working under limited supervision.
• Utilizes clinical trial applications, including Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS), ensuring accurate data entry and system updates.
• Supports the Study Team in study logistics, including product shipments, site initiation, monitoring visits, and study closeout activities, collaborating with senior team members to address and resolve logistical challenges.
• Provides inputs to Clinical Study Managers and Clinical Research Associates in managing clinical studies, ensuring compliance with all applicable regulations (ISO, GCP, FDA) and Philips procedures.
• Contributes to the seamless execution of clinical research involving human subjects, from study concept to completion, to deliver valuable insights that impact patient care and scientific advancement.
• Participates actively in multidisciplinary teams to identify and swiftly address critical issues impacting study conduct, patient welfare, and data integrity, demonstrating proactive problem-solving skills and strategic foresight.
• Handles an extensive array of study documentation, including informed consent forms, case report forms, and regulatory submissions, ensuring accuracy and compliance at every stage.
• Ensures accuracy of documents and efficient organization and accessibility of study-related materials, curating essential documents and maintaining trial master files to regulatory standards.
• Provides comprehensive support for the processes of product shipments, site initiation, monitoring visits, and study closeout activities, forging collaborative relationships with clinical sites and navigating logistical challenges.
• Executes updates to study databases and maintains accurate information within electronic data capture systems including SAP file, tracking patient enrollment and documenting study progress.
• Utilizes electronic data capture systems and technology platforms to streamline data collection processes, ensuring data accuracy, completeness, and compliance with protocol specifications.
• Implements verification and validation procedures to scrutinize study data, identifying and rectifying discrepancies with commitment to data accuracy and adherence to regulatory guidelines.
• Handles multiple tasks and priorities in an efficient manner and works effectively with internal and external clinical research stakeholders who need study support.

You are:

• Minimum 2 years of experience in the Execution of Clinical Research or equivalent with Vocational Education or no prior experience with Bachelor's Degree.
• Minimum 1 year of experience in Good Clinical Practices/International Committee on Harmonization principles and/or ISO14155 or other clinical study regulations.
• Regulatory Compliance
• Documentation & Reporting
• Troubleshooting
• Electronic Data Capture (EDC)
• Administrative Support
• Clinical Trial Management Systems (CTMS)
• Document Auditing
• Document Management
• Microsoft Office

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.