Senior Clinical Research Associate – Onco

This is a fully remote position, open to applicants in Taiwan.

📋 Description

• Oversee site qualification, initiation, monitoring, and closure activities in alignment with protocols, GCP, SOPs, and relevant regulations.

• Foster relationships with investigative sites while offering continuous support for study quality, compliance, and prompt data submission.

• Evaluate source documentation, study data, safety reporting, and informed consent procedures.

• Organize and manage regulatory and ethics documentation, ensuring readiness for inspections.

• Work alongside project teams to monitor study milestones, address operational challenges, and facilitate study delivery.

• Mentor and support less experienced CRAs and site staff.

• Contribute to the development of clinical monitoring plans, study tools, training initiatives, investigator meetings, and bid defense efforts.

• Assess investigational product accountability, site compliance, and operational workflows.

• Record findings through precise and comprehensive reports.

• Collaborate with sites, sponsors, and global study teams throughout the entire clinical trial lifecycle.

⛳️ Requirements

• MD, Pharmacy degree (MSPH, PharmD, PhD, or equivalent) with at least 3 years of experience as a Clinical Research Associate; OR a four-year degree in a medical, biological, physical, health, pharmacy, or related science field with 5 years of CRA experience; OR a two-year college degree/equivalent training (preferably in nursing or life sciences) with 7 years of CRA experience.

• Extensive background in clinical research monitoring and site management throughout the clinical trial lifecycle.

• In-depth understanding of ICH-GCP, FDA and/or EU regulations, local regulatory requirements, and clinical research methodologies.

• Strong knowledge of at least two to three therapeutic areas, with the capacity to operate as a Lead CRA.

• Proficient in EDC systems, IxRS platforms, and Microsoft Office applications.

• Exceptional communication, organizational, time management, problem-solving, and interpersonal abilities.

• Proficient in English and fluent in the local language(s) of the countries of responsibility, both written and oral.

• Full-service monitoring experience is preferred.

• Must be a resident of Taiwan.

• Willingness to travel to investigative sites approximately 8-10 days each month.

• Openness to regional travel and occasionally to other locations as required.

🏝️ Benefits

• Work-from-home arrangement.

• Opportunities for learning and professional growth.

• Collaborative and inclusive workplace culture.

• Mentorship and professional development programs.

• Global team collaboration.

• Meaningful contributions supporting life-changing therapies.