Thermo Fisher Scientific

CRA (Level II)

China

Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should possess a Bachelor’s degree in a scientific discipline, such as Biology, Chemistry, or a related field, and have at least 2 years of experience in clinical trial monitoring or site management. Strong knowledge of ICH-GCP guidelines, applicable regulations, and SOPs is essential, along with experience in risk-based monitoring and root cause analysis.

Responsibilities

The CRA (Level II) will monitor investigator sites using a risk-based approach, conducting on-site and remote visits to assess protocol and regulatory compliance. They will manage required documentation, ensure data accuracy through reviews, escalate deficiencies, and participate in investigator meetings. Additionally, the CRA will identify potential investigators, initiate clinical trial sites, conduct file reviews, provide status updates, and facilitate communication between sites, the client company, and the PPD project team, ensuring adherence to protocol and regulatory obligations.

Skills

Clinical Monitoring
Site Management
Regulatory Compliance
Documentation Management
Risk-Based Monitoring
Root Cause Analysis
Critical Thinking
Problem-Solving
GCP Guidelines
SOPs
Audit Readiness
Relationship Building

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.

Key Metrics

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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