Senior Clinical Research Associate

TL;DR

Senior Clinical Research Associate (Oncology): Overseeing site management for complex clinical trials in oncology and rare diseases with an accent on ensuring patient safety, data quality, and regulatory compliance. Focus on conducting site visits, managing start-up procedures, resolving risks, and mentoring junior staff.

Location: Remote, based in Taiwan. Travelling required (60-70%).

Company

CRO integrating clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences, focused on oncology and rare diseases.

What you will do

• Independently manage all aspects of study site management, including start-up, monitoring visits, and close-out to protect patient safety and ensure high data quality.
• Conduct pre-study, initiation, routine, and close-out visits per ICH-GCP and SOPs; perform monitoring oversight for other CRAs.
• Handle regulatory submissions, informed consent, IP accountability, SAE reporting, and risk escalation.
• Maintain ISF/TMF, track recruitment/retention, and communicate issues with sites and project teams.
• Mentor junior staff, attend investigator meetings, and support protocol/CRF development and study reports.
• Travel as needed and perform other duties assigned by management.

Requirements

• Bachelor's degree or equivalent in business, scientific, or healthcare discipline.
• Minimum 3.5 years on-site monitoring experience; oncology experience; global clinical trial experience.
• Fluency in English (verbal and written).
• Proficiency in Microsoft Office; customer service mindset; attention to detail.
• Working knowledge of drug development process.
• Travel 60-70% required.

Nice to have

• Solid clinical research experience.
• Excellent organizational skills.
• Ability to work efficiently remotely.

Culture & Benefits

• Remote work environment.
• Focus on professional image, teamwork, and flexibility.
• Equal opportunity employer.