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, Pharmaceuticals, Life SciencesIndustries

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 monitoring visits
Proficiency in data review processes (SDR, SDV, CRF review)
Skills in business writing standards for reports and letters
Experience with investigational product accountability (physical inventory and records review)
Familiarity with risk-based monitoring approaches
Ability to manage site processes and ensure audit readiness
Competence in using study systems (e.g., Clinical Trial Management System)

Responsibilities

Monitors investigator sites using a risk-based approach, identifies process failures, applies RCA, and implements 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, escalates deficiencies to management, and follows issues 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 and participates in investigator payment process
Participates in investigator meetings, identifies potential investigators, initiates clinical trial sites, and performs trial close-outs
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
Facilitates communication between sites, client, and project team via written, oral, or electronic means
Responds to company, client, and regulatory requirements/audits/inspections

Skills

Key technologies and capabilities for this role

Clinical MonitoringSite ManagementRisk-Based MonitoringICH-GCPRoot 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 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 between visits.

What skills are essential for success in this position?

Essential skills include root cause analysis, critical thinking, problem-solving, knowledge of ICH-GCP guidelines, regulations, and SOPs, as well as site process expertise 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 kind of company culture does Thermo Fisher Scientific offer?

Thermo Fisher Scientific emphasizes meaningful work with positive global impact, providing resources for career goals, fostering collaborative relationships with sites, and enabling science to advance through research and delivery of therapies.

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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