CRA (Level II)

Brazil

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, HealthcareIndustries

Requirements

The role requires a Bachelor's degree and experience in clinical monitoring and site management. Familiarity with ICH-GCP guidelines and applicable regulations is necessary. The ability to perform risk-based monitoring, conduct root cause analysis, and maintain accurate documentation is essential. Experience in assessing investigational products and ensuring audit readiness is also required.

Responsibilities

The CRA (Level II) is responsible for performing and coordinating all aspects of clinical monitoring and site management, including conducting remote or on-site visits to assess compliance with protocols, regulations, and SOPs. This includes ensuring subject rights, well-being, and data reliability, as well as assessing investigational products and documenting observations. The role involves developing relationships with investigational sites, resolving issues, tracking trial status, updating study systems, and facilitating communication between sites, clients, and the project team. Responsibilities also include participating in investigator payments, initiating sites, ensuring trial close-out, and assisting with project publications and process improvements.

Skills

Clinical Monitoring

Site Management

Protocol Compliance

Regulatory Compliance

ICH-GCP

Risk-Based Monitoring

Root Cause Analysis

Critical Thinking

Problem-Solving

Data Accuracy

SDV

CRF Review

Investigational Product

Business Writing

Trial Status Tracking

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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