CRA（Level II) at Thermo Fisher Scientific

Beijing, Beijing, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Life Sciences, PharmaceuticalsIndustries

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) and investigational product inventory
Proficiency in documentation using approved business writing standards
Capability to escalate issues and follow through to resolution
Experience with risk-based monitoring and site management processes
Familiarity with clinical trial systems (e.g., Clinical Trial Management System)
Effective communication skills (written, oral, electronic)

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 through 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 and issue resolution
Conducts supervising tasks per the approved monitoring plan
Participates in investigator payment process and shares responsibility for issue resolution
Participates in investigator meetings and identifies potential investigators
Initiates clinical trial sites per procedures, ensuring compliance and making recommendations
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 Clinical Team Manager (CTM)
Updates study systems per agreed conventions
Facilitates communication between sites, client, and 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 ManagementRisk-Based MonitoringICH-GCPSOP ComplianceProtocol ComplianceRegulatory ComplianceRoot Cause AnalysisCritical ThinkingProblem-SolvingAudit ReadinessData Accuracy

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 responsibilities of this CRA Level II role?

Key responsibilities include monitoring investigator sites using a risk-based approach, ensuring data accuracy through reviews, assessing investigational product inventory, documenting observations, escalating issues, and maintaining site contact.

What skills are essential for success in this position?

Essential skills include root cause analysis, critical thinking, problem-solving, knowledge of ICH-GCP guidelines, protocol compliance, and business writing standards.

What is the work schedule for this role?

The work schedule is standard Monday through Friday in an office environment.

What makes a strong candidate for this CRA position?

A strong candidate demonstrates determination to deliver quality and accuracy, develops collaborative relationships with sites, ensures audit readiness, and excels in site process management 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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