[Remote] FSP CRA (LevelⅡ ) at Thermo Fisher Scientific

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 data review (SDR, SDV, CRF), investigational product inventory, and records review
Proficiency in documentation using approved business writing standards
Capability to escalate deficiencies and follow issues to resolution
Experience with risk-based monitoring and site management processes
Understanding of supervising environments (FSO, FSP, Government, etc.)
Ability to maintain regular contact with sites and conduct remote/on-site visits
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, and investigational product accountability via on-site/remote activities
Documents observations in reports/letters timely, escalates issues to management, and follows through 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 processes
Participates in investigator meetings, identifies potential investigators, initiates sites, performs trial close-outs, and retrieves materials
Ensures essential documents are complete per ICH-GCP/regulations and conducts on-site file reviews
Provides trial status updates to CTM and maintains study systems (e.g., CTMS)
Facilitates communication between sites, client, and project team via written/oral/electronic means
Responds to company, client, and regulatory audits/inspections
Ensures audit readiness and develops collaborative relationships with sites

Skills

Clinical Monitoring

Site Management

ICH-GCP

Risk-Based Monitoring

Root Cause Analysis

Protocol Compliance

Regulatory Compliance

SOPs

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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