Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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 IIV 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 3050%).
