CRA (Level II)

Argentina

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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 should possess a Bachelor's degree or equivalent experience in a scientific or healthcare-related field, with proven experience as a Clinical Research Associate. Outstanding comprehension of clinical trial processes and regulations, strong analytical and problem-solving skills, the ability to work independently and collaboratively, excellent communication and organizational abilities, and a willingness to travel are required.

Responsibilities

The CRA (Level II) will monitor investigator sites using a risk-based approach, applying root cause analysis and critical thinking to identify failures and implement corrective actions. Responsibilities include ensuring data accuracy through reviews, assessing investigational products, documenting observations, escalating deficiencies, maintaining contact with sites, updating study systems, participating in investigator meetings, identifying potential investigators, initiating clinical trial sites, ensuring essential document completion, conducting file reviews, facilitating communication, responding to regulatory requirements, and maintaining administrative tasks.

Skills

Risk-based monitoring

Root Cause Analysis (RCA)

Critical Thinking

Problem-Solving

Data Accuracy

SDR

SDV

CRF Review

On-site monitoring

Remote monitoring

ICH GCP

Clinical Trial Management System (CTMS)

Business Writing

Communication

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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