FSP 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

The role requires experience in clinical monitoring and site management, with a focus on risk-based monitoring, root cause analysis, critical thinking, and problem-solving skills. Candidates must be knowledgeable in ICH-GCP guidelines and applicable regulations, with the ability to perform data accuracy checks, assess investigational products, document observations, and escalate issues. Experience in maintaining communication with investigative sites, participating in investigator meetings, identifying potential investigators, initiating clinical trial sites, and performing trial close-outs is necessary. Proficiency in updating study systems and responding to regulatory requirements is also expected.

Responsibilities

The FSP CRA (Level II) will perform and coordinate clinical monitoring and site management activities, including remote or on-site visits to assess protocol and regulatory compliance. Responsibilities include managing documentation, ensuring adherence to protocols, ICH-GCP guidelines, and SOPs, and maintaining audit readiness. The role involves developing collaborative relationships with investigational sites, ensuring data accuracy through various reviews, assessing investigational product, documenting observations, and escalating deficiencies. The CRA will also participate in the investigator payment process, resolve findings, identify and initiate clinical trial sites, perform trial close-outs, ensure crucial document completeness, provide trial status updates, and facilitate communication between sites, clients, and project teams.

Skills

Clinical Monitoring

Site Management

Protocol Compliance

Regulatory Compliance

ICH-GCP

Risk-Based Monitoring

Root Cause Analysis

Critical Thinking

Problem-Solving

Corrective and Preventive Actions

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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