About ICON plc
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research by providing a full suite of full-service development, consulting, and commercialisation services to pharmaceutical, biotechnology, and medical device customers. Our diverse and inclusive culture drives innovation and excellence, empowering our team to shape the future of clinical development and improve patient lives globally.
The Opportunity: Senior Clinical Research Associate (CRA)
We are seeking an experienced and dedicated Senior Clinical Research Associate (CRA) to join our growing Clinical Operations team in China. In this pivotal, home-based role, you will be responsible for overseeing and managing clinical trial sites primarily in the Shenyang and Changchun regions, ensuring the highest standards of quality, compliance, and patient safety. You will act as a key point of contact for investigative sites and play a critical role in the successful execution of our clinical trials.
Key Responsibilities & Duties
As a Senior CRA, you will ensure that clinical trials are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and all applicable regulatory requirements.
- Site Management & Monitoring: Perform remote and on-site monitoring visits (selection, initiation, monitoring, and close-out) to ensure protocol compliance, patient safety, and data integrity.
- Quality & Compliance: Verify that all clinical trial activities adhere to ICH-GCP, local regulations, and ICON SOPs. Proactively identify and resolve site issues or non-compliance.
- Data Integrity: Review source data verification (SDV), case report forms (eCRFs), and query resolution to ensure timely and accurate data collection and reporting.
- Site Relationship Management: Build and maintain strong, collaborative relationships with Principal Investigators and site staff, providing ongoing training and support.
- Cross-Functional Collaboration: Work closely with project managers, data management, and safety teams to support timely study milestones and deliverables.
- Mentorship: Provide guidance and support to junior CRAs, contributing to team development and knowledge sharing.
Your Profile: Qualifications & Experience
To succeed in this Senior CRA role, you will bring a combination of relevant education, experience, and soft skills:
Essential Requirements:
- Bachelor’s degree or higher in Life Sciences, Nursing, Pharmacy, Medicine, or a related scientific field.
- Minimum of 4+ years of independent, on-site monitoring experience as a CRA in the pharmaceutical, biotechnology, or CRO industry.
- In-depth knowledge of ICH-GCP guidelines and local Chinese regulatory requirements for clinical trials.
- Proven experience in managing multiple clinical sites and studies simultaneously.
- Excellent communication skills in both Mandarin and English (written and verbal).
- Strong problem-solving, organizational, and time-management abilities.
- Must possess a valid driver’s license and be willing and able to travel approximately 60-70% of the time within the region (Shenyang, Changchun, and surrounding provinces).
- Proficiency with common clinical trial software (e.g., EDC, CTMS, eTMF).
Preferred Experience:
- Experience in specific therapeutic areas relevant to ICON’s portfolio.
- Previous remote monitoring/Centralized Monitoring experience.
- Experience mentoring or leading junior staff.
What ICON Offers You
Our success depends on our people. We invest in our talent and are committed to providing an environment that fosters professional growth, well-being, and reward.
- Competitive salary and performance-based bonus/annual incentive plans.
- Comprehensive benefits package tailored to the China market, including health, life, and accident insurance.
- Retirement planning support.
- Generous annual leave entitlements.
- Global Employee Assistance Programme (EAP) offering confidential support for you and your family.
- Flexible working arrangements and a commitment to work-life balance.
- Clear career progression paths within a global industry leader.
- Continuous learning and development opportunities.
Our Commitment to Diversity & Inclusion
ICON is proud to be an equal opportunity employer. We are dedicated to building a diverse and inclusive workforce that reflects the communities we serve. 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.
We are committed to providing reasonable accommodations to qualified individuals with disabilities throughout the recruitment process. If you require an accommodation, please let us know.
Apply for This Position
Ready to advance your career with a global leader in clinical research?
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Not sure if you meet all the requirements? We encourage you to apply anyway. Your unique experience and skills may be exactly what we need for this or other roles at ICON.
