FSP 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, 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 data review (SDR, SDV, CRF) and investigational product accountability
Proficiency in business writing standards for reports and letters
Capability to escalate issues and follow through to resolution
Experience with risk-based monitoring and site management processes
Familiarity with Clinical Trial Management Systems and study conventions

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, CRF review via on-site and remote activities
Assesses investigational product via 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 sites, performs trial close-outs, and retrieves 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
Facilitates communication between sites, client, and project team via written, oral, or electronic means
Responds to company, client, and regulatory audits/inspections

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

What is the work schedule for this FSP CRA Level II position?

The position is full-time with a standard Monday-Friday work schedule.

Is this a remote position or does it require office work?

The role involves office environmental conditions and includes both remote and on-site visits to clinical 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 company emphasizes meaningful work with global impact, enabling career goals through resources for research and development, and fostering collaborative relationships in clinical research.

What makes a strong candidate for this CRA position?

Strong candidates demonstrate determination to deliver quality and accuracy, expertise as a site processes specialist, and the ability to build collaborative site relationships while ensuring audit readiness 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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