Hong Kong FSP CRA at Thermo Fisher Scientific

New Territories, Hong Kong SAR, Hong Kong SAR

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Not specified - Details are outlined in the task matrix

Responsibilities

Performs and coordinates all aspects of the clinical monitoring and site management process
Conducts remote or on-site visits to assess protocol and regulatory compliance
Manages required documentation
Acts as a site processes specialist, ensuring trial compliance with approved protocols, ICH-GCP guidelines, regulations, and SOPs
Ensures audit readiness
Develops collaborative relationships with investigational sites
Monitors investigator sites using a risk-based approach, applying RCA, critical thinking, and problem-solving skills
Ensures data accuracy through SDR, SDV, and CRF review
Assesses investigational product through physical inventory and records review
Documents observations in reports and letters, using approved business writing standards
Escalates observed deficiencies and issues to clinical management
Maintains regular contact with investigative sites to ensure protocol adherence and data timeliness
Conducts supervising tasks in accordance with the approved monitoring plan
Participates in the investigator payment process
Ensures a shared responsibility with other project team members on issue/finding resolution
Investigates and follows-up on findings as applicable
Provides trial status tracking and progress update reports to the C

Skills

Clinical Monitoring

Site Management

ICH-GCP

Risk-Based Monitoring

SDV

SDR

CRF Review

Root Cause Analysis

Protocol Compliance

Regulatory Compliance

SOPs

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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