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, BiotechnologyIndustries

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 assess compliance
Skills in data review (SDR, SDV, CRF) and investigational product inventory
Proficiency in documentation using approved business writing standards
Capability to develop collaborative relationships with investigational sites
Experience with risk-based monitoring and audit readiness
Familiarity with supervising environments (FSO, FSP, Government, etc.)

Responsibilities

Monitors investigator sites with a risk-based monitoring approach, identifying site 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, advances 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
Participates in investigator payment process and shares responsibility for issues/findings 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 (e.g., Clinical Trial Management System) per conventions
Facilitates communication between sites, client, and project team
Responds to company, client, and regulatory requirements/audits/inspections
Maintains and completes administrative tasks

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 both remote and on-site visits to investigator sites for monitoring, along with office environmental conditions.

What are the key responsibilities of a CRA Level II?

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

What skills are essential for this CRA Level II role?

Essential skills include root cause analysis, critical thinking, problem-solving, knowledge of ICH-GCP guidelines, regulations and SOPs, and the ability to develop collaborative relationships with sites.

What is the work schedule for this position?

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

What makes a strong candidate for this CRA Level II role?

A strong candidate excels in risk-based monitoring, site management, regulatory compliance, data review, and building collaborative site relationships, with a focus on quality, accuracy, and problem-solving.

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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