Accelerate the start of life-changing clinical trials in Taiwan. ICON is seeking a Site Specialist to join our Study Start-Up team. In this hybrid role, you will be the key coordinator for site activation, expertly preparing and submitting regulatory packages to ethics committees and competent authorities. Your meticulous work will ensure sites are activated efficiently and in full compliance with ICH-GCP and local Taiwanese regulations.
Key Responsibilities
You will be the operational expert driving the study start-up process, ensuring all regulatory and documentation requirements are met for timely site activation.
Regulatory Submissions & Site Activation:
- Proficiently collect, review, and assemble all regulatory documents for initial start-up submissions to Central EC/IRB, Local EC/IRB, and Competent Authorities in Taiwan.
- Support the collection and assembly of the Critical Document Package (CDP), ensuring accuracy and completeness according to checklists.
- Coordinate any necessary translations for start-up documentation and ensure all Sponsor and Investigator obligations are met.
Tracking & Forecasting:
- Perform timely and accurate data entry of all site activation activities and documents into tracking systems.
- Accurately forecast site activation plans in ICON’s systems and proactively follow through to achieve targets.
- Participate in study review meetings to identify risks to site activation and contribute to mitigation planning.
Quality Control & Compliance:
- Ensure the accuracy and completeness of the Trial Master File (TMF) during the start-up phase.
- Perform Quality Control (QC) reviews of documents before they are filed in the TMF.
- Adhere to ICON SOPs, ICH/GCP, and all applicable Taiwanese regulations and guidelines.
Your Profile
Essential Qualifications & Skills:
- Proficient knowledge of ICH/GCP guidelines and understanding of local country regulatory requirements.
- Strong organizational skills with exceptional attention to detail.
- Ability to manage multiple tasks, prioritize workload, and maintain accuracy in a fast-paced environment.
- Excellent collaboration and communication skills for working with Site Partners and internal stakeholders.
- A proactive and solutions-oriented mindset.
Why Join ICON?
Our success depends on our people. When you join ICON, you become part of a team dedicated to excellence in clinical development. We offer:
- Competitive salary and a comprehensive benefits package focused on well-being.
- Hybrid work model offering flexibility and balance.
- Health insurance and competitive retirement planning.
- Global Employee Assistance Programme and extensive well-being support.
- A diverse, inclusive culture that rewards high performance and nurtures talent.
Ready to shape the future of clinical development in Taiwan? We encourage you to apply even if you don't meet every single requirement. Your unique experience is valuable to us.
