Sr CRA II 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, PharmaceuticalsIndustries

Requirements

Knowledge of clinical trial processes, including protocol compliance, ICH-GCP guidelines, applicable regulations, and SOPs
Ability to perform risk-based monitoring using root cause analysis (RCA), critical thinking, and problem-solving skills
Skills in data review and accuracy assurance through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) review
Proficiency in documentation, report writing using approved business standards, and escalation of issues
Experience managing investigational products via physical inventory and records review
Familiarity with study systems like Clinical Trial Management System (CTMS) and performing QC checks
Capability to conduct both remote and on-site monitoring visits
Understanding of various sponsor monitoring environments (e.g., FSO, FSP, Government)
Ability to develop collaborative relationships with investigational sites and act as a site processes specialist
Availability for standard Mon-Fri office schedule, with options for fully remote, hybrid, or fully office (Gangnam, Seoul)

Responsibilities

Perform and coordinate all aspects of clinical monitoring and site management, including remote or on-site visits to assess protocol and regulatory compliance
Manage required documentation and ensure audit-readiness
Monitor investigator sites using a risk-based approach, identifying process failures and implementing corrective/preventive actions
Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote activities
Assess investigational products through physical inventory and records review
Document observations in reports and letters timely using approved standards
Escalate deficiencies and issues to clinical management and follow through to resolution
Maintain regular contact with sites between visits to confirm protocol adherence, issue resolution, and timely data recording
Conduct monitoring tasks per the approved monitoring plan
Participate in the investigator payment process
Share responsibility with project team on issues/findings resolution and investigate/follow-up as applicable
Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM)
Update study systems (e.g., CTMS) per agreed conventions and perform QC checks on CTMS reports
Participate in investigator meetings as necessary
Identify potential investigators in collaboration with clients to ensure qualified sites
Initiate clinical trial sites according to relevant procedures for compliance with protocol, regulatory, and ICH-GCP obligations

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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