Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Thermo Fisher Scientific Inc. in Taiwan as a Senior CRA for innovative cell and gene therapy research.

Key Responsibilities

Clinical Monitoring and Oversight

• Conduct on-site and remote monitoring visits (site qualification, initiation, routine, and close-out) in strict compliance with ICH-GCP, SOPs, and study-specific requirements.
• Verify the accuracy, completeness, and consistency of source data, eCRF entries, and essential documents.
• Ensure accurate investigational product (IP) management, including receipt, storage, accountability, and temperature monitoring, with heightened focus on CGT-specific chain of identity and chain of custody.
• Assess the adherence of the site to protocol and regulatory prerequisites, guaranteeing the safety of subjects and the integrity of data.
• Identify, document, and track protocol deviations and site issues; ensure timely follow-up and resolution.

Cell & Gene Therapy-Specific Oversight

• Coordinate specialized processes such as apheresis, manufacturing coordination, and product infusion, ensuring compliance with handling and traceability requirements.
• Collaborate with manufacturing, logistics, and supply chain teams to ensure accurate tracking of patient-specific material.
• Supervise essential stages in the chain of identity (CoI) and chain of custody (CoC) to guarantee product traceability from pick-up to delivery.
• Review and ensure accurate documentation for temperature excursions, product release certificates, and related vendor activities.

Leadership and Mentorship

• Serve as a lead CRA for complex trials.
• Support training, mentoring, and oversight of less experienced CRAs or new team members.
• Provide operational advice to the project manager or clinical team lead for study planning, risk management, and handling partner concerns.

Communication and Collaboration

• Build and maintain effective relationships with investigators, site personnel, vendors, and internal study teams.
• Participate in investigator meetings, monitoring team calls, and cross-functional study reviews.
• Proactively communicate potential risks or challenges to the study team and contribute to mitigation planning.

Documentation and Reporting

• Prepare and submit comprehensive monitoring visit reports (MVRs) and follow-up letters within required timelines.
• Keep current site files and review documentation following sponsor SOPs and regulatory standards.
• Ensure all action items and follow-up activities are detailed and tracked to closure.

Qualifications and Experience

• Bachelor’s degree or equivalent experience in Life Sciences, Nursing, Pharmacy, or a related field. Minimum of 5 years of clinical monitoring experience, including experience in Phase I–IV clinical trials.
• At least 3 years of hands-on experience in Cell & Gene Therapy (CGT) or other Advanced Therapy Medicinal Product (ATMP) studies.
• Strong knowledge of ICH-GCP, local and regional regulatory requirements, and global clinical trial operations.
• Proven ability to independently manage clinical sites, assess compliance, and ensure data integrity.
• Experience with EDC systems, eTMF, CTMS, and CGT-specific documentation workflows.
• Demonstrated critical thinking, problem-solving, and risk assessment skills in complex study environments.
• Excellent communication, collaboration, and time management abilities.
• Strong interpersonal skills, with experience mentoring or supporting junior CRAs preferred.
• Ability to work effectively in a matrix and cross-functional team environment.
• Willingness and ability to travel as required (approximately 30–50%).