Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates must have experience as a Clinical Research Associate (CRA) and be proficient in risk-based monitoring, root cause analysis, critical thinking, and problem-solving. Familiarity with data accuracy checks (SDR, SDV, CRF review), investigational product assessment, and business writing standards is necessary. The role requires the ability to escalate issues, maintain communication with investigative sites, and update study systems like CTMS. Experience with site initiation, trial close-out, document management according to ICH-GCP, and participating in investigator meetings is also required.

Responsibilities

The Sr CRA will monitor investigator sites using a risk-based approach, identifying process failures and implementing corrective actions to ensure compliance. They will ensure data accuracy through various review methods, assess investigational products, and document observations in timely reports. Responsibilities include escalating deficiencies, managing site communication, updating study systems, participating in investigator payments, and conducting file reviews. The role also involves identifying potential investigators, initiating clinical trial sites, ensuring trial close-out, and maintaining essential study documents. Additionally, the Sr CRA will contribute to project teams, facilitate communication between sites and the project team, respond to regulatory requirements, and complete administrative tasks.

Skills

Risk-based monitoring
Root cause analysis
Critical thinking
Problem-solving
Data accuracy
SDR review
SDV review
CRF review
Investigational product assessment
Report writing
Business writing
Issue escalation
Protocol compliance
ICH GCP
Clinical Trial Management System (CTMS)
Clinical trial site initiation
Trial close out

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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