Sr. CRA (Cell and Gene Therapy)
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Job Location:
Taipei City - Taiwan
Monthly Salary:
Not Disclosed
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Thermo Fisher Scientific 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
- Bachelors 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%).
Required Experience:
Senior IC
Key Skills
- Employee Evaluation
- HIPAA
- Data Collection
- HTTPS
- Physiology Knowledge
- Physio therapy
- Computer Literacy
- Patient Assessment
- Pediatrics Experience
- Home Care
- Critical Care Experience
- Patient Service Experience
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
