Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates must possess a Bachelor's degree in a life science-related field or a Registered Nursing certification. Experience in clinical monitoring and site management is required, with a focus on risk-based monitoring approaches, root cause analysis, and critical thinking. Familiarity with ICH-GCP guidelines and applicable regulations is essential.

Responsibilities

The CRA (Level II) will perform and coordinate all aspects of clinical monitoring and site management, including conducting remote or on-site visits to assess compliance and managing documentation. Responsibilities include ensuring data accuracy through SDR, SDV, and CRF review, assessing investigational product, documenting observations, escalating deficiencies, and maintaining communication between sites, clients, and project teams. The role also involves participating in investigator meetings, initiating clinical trial sites, performing trial close-out, ensuring essential document completion, providing status updates, and responding to regulatory requirements.

Skills

Clinical Monitoring
Site Management
ICH-GCP
Regulatory Compliance
Risk-Based Monitoring
Root Cause Analysis
Critical Thinking
Problem-Solving
Data Accuracy
SDR
SDV
CRF Review
Investigational Product Assessment
Audit Readiness
Business Writing

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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