Assistant CRA

Germany

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical Research ServicesIndustries

Requirements

The Assistant CRA role requires a strong understanding of FDA and/or local regulations and guidelines, ICH GCPs, and company procedural documents. Candidates should possess excellent communication and problem-solving skills, with the ability to conduct remote site management and monitoring activities. Experience with electronic data capture (EDC) systems and risk-based monitoring approaches is beneficial.

Responsibilities

The Assistant CRA will perform remote site management and monitoring for assigned clinical research projects. This includes reviewing study data, contacting study sites to resolve issues and collect documentation, tracking subject data, and raising queries in EDC. Responsibilities also involve evaluating site performance, providing refresher training, assisting with regulatory reviews, and reporting trial status updates to the study manager.

Skills

Clinical Research

Data Management

Regulatory Compliance

Therapeutic Areas

Patient Safety

Study Monitoring

Good Clinical Practice (GCP)

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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