Guardian of Clinical Integrity: Clinical Research Associate II (CRA II) – Hong Kong (Remote)
At ICON, our mission depends on the rigour and precision of our clinical monitoring. As a remote-based CRA II in Hong Kong, you will be the frontline expert safeguarding patient safety, data integrity, and protocol adherence at our investigative sites. This isn't just about monitoring—it's about being the trusted scientific partner who ensures every data point tells the true story of a potential new therapy.
We are looking for an experienced, independent, and meticulous Clinical Research Associate to manage the full site lifecycle for complex clinical trials. If you are driven by scientific excellence, excel at building collaborative site relationships, and thrive on ensuring trials are conducted to the highest ethical and regulatory standards, this is your role.
Your Role: The Protector of the Protocol
Site Leadership & Oversight
- Conduct the complete cycle of site management: qualification, initiation, routine monitoring, and close-out visits, ensuring strict compliance with study protocols, ICH-GCP, and local regulatory requirements.
- Serve as the primary point of contact for assigned investigative sites, building partnerships with investigators and staff to ensure smooth study execution and proactive issue resolution.
Vigilance for Data & Safety
- Perform comprehensive source data verification (SDV) and meticulous review of case report forms (eCRFs/CRFs), guaranteeing accuracy, consistency, and completeness of all clinical data.
- Act as a guardian of patient safety and rights, verifying that all site activities adhere rigorously to the approved protocol and ethical standards.
- Proactively identify, document, and address site issues, deviations, or compliance gaps, driving timely and effective corrective and preventive actions.
Excellence in Documentation & Collaboration
- Contribute to the preparation, review, and finalization of essential study documentation, including protocols, clinical study reports (CSRs), and monitoring visit reports.
- Ensure the collection and maintenance of all essential regulatory documents in the Trial Master File (TMF), keeping your sites in a constant state of audit and inspection readiness.
- Support sites with regulatory and safety reporting obligations, including the management of Serious Adverse Event (SAE) reporting.
- Collaborate seamlessly with cross-functional internal teams (Clinical Operations, Data Management, Safety) to ensure aligned study progress and rapid resolution of challenges.
Who You Are
You are a proactive professional who sees beyond the checklist. You understand that your critical eye and relationship-building skills directly impact patient safety and the success of pioneering clinical research.
Your Foundation
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related healthcare/scientific field.
- Minimum of 2 years of independent, on-site Clinical Research Associate (CRA) monitoring experience within a CRO, pharmaceutical, or biotechnology setting.
- In-depth knowledge of clinical trial processes, ICH-GCP guidelines, and relevant regulatory landscapes.
- Professional fluency in Cantonese and English (written and verbal) is essential.
- Ability to travel approximately 60% of the time within the region, with a valid driver’s license.
Your Core Strengths
- Independent & Detail-Oriented: You manage your sites and priorities with exceptional organization and an unwavering focus on data quality.
- Exceptional Communicator: You build trust easily, negotiate effectively, and resolve issues with professionalism and clarity.
- Problem-Solver: You anticipate risks, diagnose root causes, and implement practical solutions to keep studies on track.
- Collaborative Professional: You are a reliable team player who contributes positively to both local and global virtual teams.
Why Join ICON in Hong Kong?
Impact Where It Matters
Your work directly enables the development of new treatments for patients in Hong Kong and beyond. You ensure the science is uncompromised.
Grow Your Career Remotely
- 100% Remote Role: Maximize your effectiveness and work-life balance while conducting vital monitoring across Hong Kong.
- Clear Pathways for Advancement: Progress to Senior CRA, Lead CRA, and Clinical Team Lead roles within a global structure.
- Continuous Development: Receive comprehensive training and mentorship in a culture that nurtures talent and rewards high performance.
Supportive Culture & Benefits
Join a diverse, inclusive team where belonging and innovation are core to our values. We offer a competitive salary, performance incentives, comprehensive health and retirement plans, generous leave, and a global employee assistance program.
Ready to Be the Trusted Expert?
If you are a dedicated CRA passionate about upholding the highest standards of clinical research from a remote base in Hong Kong, we encourage you to step forward.
Apply now to become the vital link between groundbreaking science and real-world impact.
