Sr. CRA (Cell and Gene Therapy) at Thermo Fisher Scientific

Taipei, Taiwan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell and Gene TherapyIndustries

Requirements

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%)

Responsibilities

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
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
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
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
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

Skills

ICH-GCP

Clinical Monitoring

eCRF

Investigational Product Management

Chain of Identity

Chain of Custody

Apheresis

Cell and Gene Therapy

Protocol Deviations

Site Management

Regulatory Compliance

SOPs

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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