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

Candidates must have experience with risk-based monitoring, root cause analysis, critical thinking, and problem-solving skills. They should be proficient in data accuracy checks, investigational product assessment, and maintaining site compliance with protocols and ICH GCP guidelines. Experience in identifying potential investigators and initiating clinical trial sites is also required, along with the ability to respond to regulatory requirements and audits.

Responsibilities

The CRA (Level II) will monitor investigator sites using a risk-based approach, ensuring data accuracy through SDR, SDV, and CRF reviews. Responsibilities include assessing investigational product, documenting observations, and resolving identified deficiencies. The role involves maintaining communication with investigative sites, updating study systems, participating in investigator meetings, and ensuring the completion of essential trial documents. Additionally, the CRA will facilitate communication between sites, the client, and the project team, and assist with project publications and process improvement initiatives.

Skills

Risk-based monitoring

Root cause analysis

Critical thinking

Problem-solving

Data accuracy

SDR review

SDV review

CRF review

Clinical trial monitoring

Investigational product assessment

Report writing

Clinical trial management

ICH GCP

Clinical Trial Management System (CTMS)

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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