[Remote] FSP CRAII at Thermo Fisher Scientific

China

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

The role requires a strong understanding of clinical monitoring and site management processes, including ICH-GCP guidelines and applicable regulations. Candidates should be proficient in risk-based monitoring, root cause analysis, critical thinking, and problem-solving. Experience with data accuracy checks, investigational product assessment, and document management is necessary. The ability to maintain effective communication and provide trial status updates is also essential.

Responsibilities

The FSP CRAII is responsible for performing and coordinating clinical monitoring activities, including remote and on-site visits to assess protocol and regulatory compliance. This includes managing documentation, ensuring data accuracy through reviews, assessing investigational products, and documenting observations in timely reports. The role involves escalating deficiencies, maintaining communication with investigative sites, participating in investigator meetings, and ensuring the completion and accuracy of essential trial documents. Responsibilities also include updating study systems, facilitating communication between sites, clients, and project teams, and responding to regulatory requirements and audits.

Skills

Clinical monitoring
Site management
Protocol compliance
Regulatory compliance
ICH-GCP guidelines
Risk-based monitoring
Root cause analysis
Critical thinking
Problem-solving
Corrective/preventive actions

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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