Shape the Future of Clinical Development
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.
We are seeking a proactive and detail-oriented Clinical Research Associate (CRA) to specialize in Phase IV post-marketing and investigator-initiated studies. In this role, you will be at the forefront of implementing real-world research, working closely with healthcare professionals and internal teams to manage studies that generate critical evidence for marketed products. You will ensure these studies are conducted with the highest quality, within budget, and in full compliance with regulations.
Your Responsibilities
Study Implementation & Site Management
- Design and implement Local/Regional/Global Phase IV studies, including Late Phase (LDG), Health Economics (HECON), and Post-Approval studies.
- Generate site feasibility questionnaires, conduct site selection visits, and develop start-up plans to ensure timely study initiation.
- Manage all aspects of site relationships: negotiate contracts and budgets, provide professional guidance to investigators, and maintain excellent rapport with site personnel.
- Prepare and submit dossiers for IRB/EC and regulatory authority (RA) approvals.
Operational Excellence & Compliance
- Plan and evaluate study timelines, Fair Market Value (FMV), budgets, and resource requirements.
- Conduct denied party screenings and anti-bribery/corruption checks for investigator-initiated studies.
- Ensure the study database is accurately updated and maintained throughout the study lifecycle.
- Coordinate study material allocation and delivery to sites.
- Send quarterly status update requests and track study progress against milestones.
- Contribute to audits, inspections, and quality assurance activities.
Stakeholder Collaboration
- Work closely with internal teams (Medical Affairs, Project Management, Legal) and external stakeholders to execute studies seamlessly.
- Communicate effectively regarding budget allocation, execution plans, and study updates.
Your Profile: Qualifications & Skills
Education & Experience
- A Bachelor’s degree in Pharmacy, Biology, Medical Science, Nursing, or a related life sciences field.
- 1-3 years of direct experience in handling clinical trials or investigator-initiated studies (IIS). Experience in Phase IV/post-marketing studies is highly valued.
- Strong understanding of GCP (Good Clinical Practice), GPP (Good Publication Practice), and IRB submission processes.
Core Competencies
- Project Management: Strong organizational skills, a sense of urgency, and the ability to manage multiple priorities to drive studies to completion.
- Communication & Relationship Building: Excellent proficiency in both Chinese and English (verbal and written). Ability to build and maintain strong professional relationships.
- Ethics & Integrity: Demonstrated commitment to ethical conduct and compliance in clinical research.
- Customer & Patient Focus: A results-driven mindset centered on delivering value for customers and ultimately benefiting patients.
Why Join ICON?
Our success depends on the quality of our people. That’s why we prioritize building a diverse culture that rewards high performance and nurtures talent.
We Offer a Competitive Benefits Package Focused on Well-Being:
- Generous Annual Leave entitlements.
- Comprehensive Health Insurance options for you and your family.
- Competitive Retirement Planning offerings to secure your future.
- Global Employee Assistance Programme providing 24/7 confidential support for well-being.
- Life Assurance coverage.
- Flexible, Country-Specific Benefits which may include wellness programs, subsidized travel, and more.
Our Commitment to You:
At ICON, inclusion and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Ready to advance real-world evidence and patient care?
Apply now for the Clinical Research Associate (Phase IV) position in China.
We encourage all interested candidates to apply. If you require a reasonable accommodation during the application process, please inform us.
