CRA(Level II) at Thermo Fisher Scientific

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Applies root cause analysis (RCA), critical thinking and problem-solving skills
Knowledge of protocol compliance, ICH-GCP guidelines, applicable regulations, and SOPs
Ability to conduct remote or on-site visits and manage documentation
Skills in business writing standards for reports and letters
Familiarity with risk-based monitoring, SDR, SDV, and CRF review
Experience with investigational product inventory and records review
Ability to escalate deficiencies and follow issues to resolution
Competence in supervising tasks per monitoring plan and investigator payment process
Skills in site initiation, close-out, and file reviews per ICH-GCP and regulations
Proficiency in study systems (e.g., Clinical Trial Management System) and trial status tracking
Effective communication skills (written, oral, electronic) with sites, clients, and teams
Responsiveness to audits, inspections, and regulatory requirements

Responsibilities

Monitors investigator sites using a risk-based approach, identifying process failures and corrective/preventive actions
Ensures data accuracy through SDR, SDV, and CRF review via on-site and remote activities
Assesses investigational product via physical inventory and records review
Documents observations in reports and letters timely using approved standards
Escalates deficiencies/issues to clinical management and follows through to resolution
Maintains regular contact with sites between visits to confirm protocol adherence, issue resolution, and timely data recording
Conducts supervising tasks per the approved monitoring plan
Participates in the investigator payment process
Shares responsibility with project team on issues/findings resolution and investigates/follows up as applicable
Participates in investigator meetings and identifies potential investigators with client collaboration
Initiates clinical trial sites per procedures, ensuring protocol, regulatory, and ICH-GCP compliance
Performs trial close-out and retrieval of trial materials
Ensures crucial documents are complete per ICH-GCP and regulations; conducts on-site file reviews
Provides trial status tracking and progress updates to the Clinical Team Manager (CTM)
Updates study systems per agreed conventions
Facilitates communication between sites, client, and PPD project team
Responds to company, client, and regulatory requirements/audits/inspections
Maintains and completes required documentation

Skills

Key technologies and capabilities for this role

Clinical MonitoringSite ManagementICH-GCPRisk-Based MonitoringRoot Cause AnalysisProtocol ComplianceRegulatory ComplianceSOPsAudit ReadinessCritical ThinkingProblem-Solving

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

The role involves conducting remote or on-site visits to clinical sites for monitoring and site management.

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

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

What is the work schedule for this position?

This is a full-time position with a standard Monday-Friday work schedule in an office environment.

What does the company culture emphasize at Thermo Fisher Scientific?

The company emphasizes meaningful work with positive global impact, enabling customers to make the world healthier, cleaner, and safer, while providing resources for career goals and advancing science through research and delivery of therapies.

What makes a strong candidate for this CRA role?

Strong candidates demonstrate determination to deliver quality and accuracy, skills in site process management, building collaborative relationships with sites, and expertise in risk-based monitoring and compliance.

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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