CRA II | Australia Wide at Thermo Fisher Scientific

Melbourne, Victoria, Australia

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
Minimal clinical monitoring experience (comparable to 2 years) in a clinical environment where experience is gained in clinical trials
Valid driver's license where applicable
In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience
Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations and procedural documents
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through the utilization of good listening skills and attention to detail
Good organizational and time management skills
Ability to remain flexible and adaptable in a wide range of scenarios
Well-developed critical thinking skills and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Ability to work in a team or independently as required
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
Able to work upright and stationary for typical working hours
Able to perform successfully under pressure while prioritizing and balancing multiple projects or activities
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments
Requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains
Currently live in or close to one of the following cities: Brisbane, Adelaide, Perth, Sydney, Melbourne

Responsibilities

Performs and coordinates different aspects of the clinical monitoring and site management process
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation
Leads procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.)
Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability
Ensures audit readiness
Develops collaborative relationships with investigational sites
Develops collaborative relationships with investigational sites and client company personnel
Detailed tasks and responsibilities assigned to role are outlined in the task matrix

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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