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

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 risk-based monitoring, including SDR, SDV, and CRF review
Proficiency in documentation, report writing using approved business standards, and escalation procedures
Capability to conduct remote and on-site visits, physical inventory, and records review
Experience with supervising tasks per monitoring plans and investigator payment processes
Competence in trial initiation, close-out, and retrieval of materials
Ability to ensure crucial documents are complete per ICH-GCP and regulations
Skills in trial status tracking, progress reporting, and updating study systems (e.g., Clinical Trial Management System)
Strong communication skills (written, oral, electronic) with sites, clients, and project teams
Preparedness for audits, inspections, and regulatory requirements

Responsibilities

Monitors investigator sites using a risk-based approach: applies RCA, identifies process failures, ensures data accuracy via SDR/SDV/CRF review, assesses investigational product, documents observations, escalates issues, maintains contact between visits, and conducts supervising tasks per monitoring plan
Participates in investigator meetings, identifies potential investigators with client collaboration, initiates clinical trial sites per procedures, and performs trial close-out and material retrieval
Ensures crucial documents are complete and conducts on-site file reviews per project specifications
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) and updates study systems per conventions
Facilitates communication between investigative sites, client company, and PPD project team
Responds to company, client, and regulatory audits/inspections
Manages procedures and guidelines from sponsors/supervising environments (FSO, FSP, Government, etc.)
Acts as site processes specialist to ensure trial conduct per protocol, ICH-GCP, regulations, and SOPs, guaranteeing subject rights, well-being, data reliability, and audit readiness
Develops collaborative relationships with investigational sites and shares responsibility for issue/findings resolution

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

What is the work schedule for this FSP CRA role?

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, with responsibilities including both remote and on-site visits to investigator sites.

What key skills are required for this CRA Level II position?

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 career goals through resources for research and development, and fostering collaborative relationships in clinical research.

What makes a strong candidate for this FSP CRA role?

Strong candidates demonstrate determination to deliver quality and accuracy, expertise in site management and monitoring, and the ability to build collaborative site relationships while ensuring compliance and audit readiness.

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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