Senior CRA - Remote New Zealand

New Zealand

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

Requirements

Candidates should possess three or more years of onsite monitoring experience with at least one year within New Zealand, and the ability to travel 40%-60% including occasional overnight travel nationally and internationally. Strong knowledge of clinical monitoring and site management processes is required, along with experience in ensuring protocol and regulatory compliance and adherence to ICH-GCP guidelines and SOPs.

Responsibilities

This Senior CRA will perform and coordinate all aspects of the clinical monitoring and site management process, conducting remote or on-site visits to assess compliance and manage documentation. The role involves managing procedures, acting as a site processes specialist, ensuring audit readiness, developing relationships with investigational sites, monitoring investigator sites with a risk-based approach, documenting observations in reports, escalating issues, maintaining contact with sites, participating in the investigator payment process, and providing trial status updates to the Clinical Team Manager.

Skills

Clinical Monitoring

Site Management

Study Coordination

Regulatory Compliance

Travel Coordination

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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