FSP CRA (Sponsor: Biogen) at Thermo Fisher Scientific

Seoul, South Korea, South Korea

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceutical, Clinical ResearchIndustries

Requirements

University degree in a nursing / life-sciences field
Experience of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation (at least 2 years)
Neurology experience preferred
Demonstrated understanding of ICH-GCP, MFDS and FDA requirements
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Exceptional communication, collaboration, organisational and time management skills
Fluency in English

Responsibilities

Perform and coordinate all aspects of the clinical monitoring process and conduct monitoring activities independently
Monitor investigator sites with a risk-based monitoring approach: apply root cause analysis (RCA), critical thinking and problem-solving skills to identify site process failures and corrective/preventive actions
Ensure data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities
Assess investigational product through physical inventory and records review
Document observations in reports and letters according to timelines using approved business writing standards
Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution
Maintain regular contact between monitoring visits with investigative sites to confirm protocol adherence, resolution of previously identified issues, and timely data recording
Participate in the investigator payment process
Ensure shared responsibility with other project team members on issues/findings resolution and investigate/follow-up on findings as applicable
Participate in investigator meetings as necessary
Identify potential investigators in collaboration with the client company to ensure acceptability of qualified investigative sites
Initiate clinical trial sites according to relevant procedures to ensure compliance with protocol, regulatory and ICH GCP obligations, making recommendations where warranted
Perform trial close out and retrieval of trial materials
Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations; conduct on-site file reviews as per project specifications
Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required
Ensure study systems are updated per agreed study conventions (e.g., Clinical Trial Management System)

Skills

Clinical Monitoring

Risk-Based Monitoring

Root Cause Analysis

SDV

SDR

CRF Review

GCP

Site Management

Investigator Meetings

Protocol Compliance

Data Accuracy

Corrective Actions

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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