FSP CRA (Level II) at Thermo Fisher Scientific

Guangzhou, Guangdong Province, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

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 for monitoring and site management
Proficiency in data review processes (SDR, SDV, CRF review)
Skills in business writing standards for reports and letters
Capability to manage investigational product inventory and records
Experience with risk-based monitoring approach
Ability to escalate issues and follow through to resolution
Familiarity with supervising tasks, monitoring plans, and investigator payment processes
Knowledge of audit readiness and regulatory requirements/audits/inspections

Responsibilities

Monitors investigator sites with a risk-based monitoring approach, identifies site process failures, and implements corrective/preventive actions
Ensures data accuracy through SDR, SDV, and CRF review via on-site and remote monitoring
Assesses investigational product through physical inventory and records review
Documents observations in reports and letters timely using approved standards
Escalates deficiencies and 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 the investigator payment process
Shares responsibility with project team on issues/findings resolution and investigates/follows up on findings
Participates in investigator meetings and identifies potential investigators in collaboration with the client
Initiates clinical trial sites per procedures, ensuring compliance with protocol, regulatory, and ICH-GCP obligations
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 update reports to the Clinical Team Manager (CTM)
Updates study systems (e.g., Clinical Trial Management System) per conventions
Facilitates communication between sites, client, and PPD project team via written, oral, or electronic contacts
Responds to company, client, and regulatory requirements/audits/inspections

Skills

Clinical Monitoring

Site Management

Risk-Based Monitoring

Root Cause Analysis

ICH-GCP

Protocol Compliance

Regulatory Compliance

SOPs

Data Accuracy

SDR

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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