[Remote] FSP CRA (Level II) at Thermo Fisher Scientific

China

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Knowledge of protocol compliance, ICH-GCP guidelines, applicable regulations, and SOPs
Ability to apply root cause analysis (RCA), critical thinking, and problem-solving skills
Skills in data review (SDR, SDV, CRF), investigational product inventory, and documentation using approved business writing standards
Capability to conduct remote or on-site monitoring visits and manage site processes
Experience with risk-based monitoring, audit readiness, and escalating issues
Proficiency in trial initiation, close-out, investigator meetings, and site selection collaboration
Familiarity with clinical trial management systems and study conventions
Strong communication skills (written, oral, electronic) with sites, clients, and teams
Responsiveness to audits, inspections, and regulatory requirements

Responsibilities

Monitors investigator sites using risk-based approach, including RCA, identifying process failures, corrective/preventive actions, data accuracy checks (SDR, SDV, CRF), product inventory, timely documentation, issue escalation, and follow-up
Maintains regular contact with sites between visits to ensure protocol adherence, issue resolution, and timely data recording
Conducts supervising tasks per monitoring plan and participates in investigator payment process
Participates in investigator meetings, identifies potential investigators, initiates sites per procedures, performs trial close-out and material retrieval
Ensures crucial documents are complete per ICH-GCP and regulations, conducts on-site file reviews
Provides trial status tracking and progress updates to Clinical Team Manager (CTM), updates study systems (e.g., CTMS)
Facilitates communication between sites, client, and project team
Responds to company, client, and regulatory audits/inspections
Shares responsibility with project team on issues/findings resolution and investigates follow-ups

Skills

Key technologies and capabilities for this role

Clinical MonitoringSite ManagementICH-GCPRisk-Based MonitoringRoot Cause AnalysisRegulatory ComplianceProtocol ComplianceSOPsAudit ReadinessSDR

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time employment opportunity.

What is the work schedule and location for this role?

The work schedule is standard Monday-Friday in an office environment, involving both remote and on-site visits to investigator sites.

What key skills are required for the FSP CRA Level II role?

Key skills include risk-based monitoring, root cause analysis, critical thinking, problem-solving, and ensuring compliance with ICH-GCP guidelines, regulations, and SOPs.

What is the company culture like at Thermo Fisher Scientific?

The culture emphasizes meaningful work with global impact, enabling customers to make the world healthier through research and delivery of life-changing therapies, while providing resources for individual career goals.

What makes a strong candidate for this CRA position?

Strong candidates demonstrate determination to deliver quality and accuracy, skills in site management, regulatory compliance, developing collaborative relationships with sites, and experience in clinical monitoring processes.

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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