CRA (Level II)

China

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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, Clinical ResearchIndustries

Requirements

Candidates must have experience in clinical monitoring and site management, including conducting remote or on-site visits to assess protocol and regulatory compliance. A strong understanding of ICH-GCP guidelines, applicable regulations, and SOPs is required. Experience with risk-based monitoring, root cause analysis, and critical thinking is necessary. The role requires the ability to document observations, escalate deficiencies, and maintain communication with investigative sites, clients, and project teams. Experience with investigator meetings, site initiation, trial close-out, and document retrieval is also needed. The ability to track study progress and provide update reports is essential.

Responsibilities

The CRA (Level II) will perform and coordinate clinical monitoring and site management activities, ensuring compliance with protocols, ICH-GCP guidelines, and regulations. Responsibilities include assessing investigational product, documenting observations, escalating issues, and resolving findings. The role involves maintaining communication between sites, clients, and project teams, responding to regulatory requirements, and ensuring study systems are updated. Additionally, the CRA will participate in investigator payment processes, identify potential investigators, initiate clinical trial sites, and perform trial close-out activities, ensuring all crucial documents are complete and in place.

Skills

Clinical Monitoring

Site Management

Protocol Compliance

Regulatory Compliance

ICH-GCP

Risk-Based Monitoring

Root Cause Analysis

Problem-Solving

Data Accuracy

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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