Sr. CRA I at Thermo Fisher Scientific

Seoul, South Korea, South Korea

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Not SpecifiedCompensation

Senior (5 to 8 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, site management, and documentation management
Experience with remote and on-site monitoring visits, SDR, SDV, and CRF review
Familiarity with different sponsors/monitoring environments (e.g., FSO, FSP, Government)
Proficiency in using study systems like Clinical Trial Management System (CTMS)
Strong business writing standards for reports and letters
Ability to develop collaborative relationships with investigational sites
Audit-readiness capabilities

Responsibilities

Performs and coordinates all aspects of clinical monitoring and site management
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages documentation
Monitors investigator sites using a risk-based approach, identifying process failures and corrective/preventive actions
Ensures data accuracy through SDR, SDV, and CRF review via on-site and remote activities
Assesses investigational products through physical inventory and records review
Documents observations in reports and letters timely using approved standards
Escalates deficiencies/issues to clinical management and follows through to resolution
Maintains regular contact with sites between visits to ensure protocol adherence and issue resolution
Conducts monitoring tasks per the approved monitoring plan
Participates in investigator payment process
Shares responsibility with project team on issues/findings resolution and follow-up
Provides trial status tracking and progress update reports to Clinical Team Manager (CTM)
Ensures study systems (e.g., CTMS) are updated per conventions and performs QC checks on reports
Participates in investigator meetings as necessary
Identifies potential investigators in collaboration with client to ensure qualified sites
Initiates clinical trial sites according to relevant procedures for compliance with protocol, regulations, and ICH-GCP

Skills

Clinical Monitoring

Site Management

ICH-GCP

Protocol Compliance

Regulatory Compliance

SOPs

Audit Readiness

Clinical Trials

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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