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 OversightCoordinate 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 MentorshipServe 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 CollaborationBuild 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 ReportingPrepare 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 ExperienceBachelor’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%).