Clinical Research Associate, level II or Senior at Thermo Fisher Scientific

Romania

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Junior (1 to 2 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should possess a Bachelor’s degree in a scientific discipline, such as biology, chemistry, or a related field, and have a minimum of 2 years of experience in clinical research, with at least 1 year in a CRA role preferred. Strong knowledge of clinical trial regulations, including ICH-GCP guidelines and applicable FDA regulations, is essential. Excellent communication, organizational, and problem-solving skills are required, along with the ability to work independently and as part of a team. Experience with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is also desired.

Responsibilities

The Clinical Research Associate will conduct remote or on-site visits to clinical trial sites to monitor protocol adherence and data integrity, ensuring compliance with regulations and guidelines. They will perform source data verification, conduct investigational product assessments, document observations in reports, and resolve issues identified during monitoring. The CRA will also assist in identifying and initiating clinical trial sites, participate in investigator meetings, contribute to trial close-out activities, and maintain communication with investigative sites and internal project teams, while ensuring adherence to study systems and responding to regulatory requirements.

Skills

clinical monitoring
site management
audit readiness
protocol compliance
ICH-GCP guidelines
regulatory compliance
documentation management
risk-based monitoring
root cause analysis
data review
remote monitoring
on-site monitoring

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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