CRA II - Brisbane, Sydney, Adelaide, Perth at Thermo Fisher Scientific

Brisbane, Queensland, Australia

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

Home-based position, preferably based in Brisbane, Sydney, Adelaide, or Perth
Knowledge of ICH-GCP guidelines, applicable regulations, and SOPs
Ability to apply root cause analysis (RCA), critical thinking, and problem-solving skills
Skills in risk-based monitoring, site management, and protocol compliance
Proficiency in data review processes (SDR, SDV, CRF review)
Capability to conduct remote and on-site visits, documentation, and reporting using approved standards
Experience with investigational product accountability and inventory
Ability to escalate issues, maintain site contact, and ensure audit readiness
Collaborative relationship-building with sites, clients, and project teams

Responsibilities

Monitors investigator sites using a risk-based approach, identifying process failures and implementing corrective/preventive actions
Ensures data accuracy through SDR, SDV, and CRF review via on-site and remote activities
Assesses investigational product via physical inventory and records review
Documents observations in reports and letters timely, using approved writing standards
Escalates deficiencies/issues to clinical management and follows through to resolution
Maintains regular contact with sites between visits to confirm protocol adherence, issue resolution, and timely data recording
Conducts supervising tasks per the approved monitoring plan
Participates in investigator payment process and shares responsibility for issue resolution
Investigates and follows up on findings
Participates in investigator meetings and identifies potential investigators with client collaboration
Initiates clinical trial sites per procedures, ensuring compliance with protocol, regulations, and ICH-GCP
Performs trial close-out and retrieval of trial materials
Ensures crucial documents are complete per ICH-GCP and regulations; conducts on-site file reviews
Provides trial status tracking and progress updates to Clinical Team Manager (CTM)
Updates study systems (e.g., Clinical Trial Management System) per conventions
Facilitates communication between sites, client, and PPD project team via written, oral, or electronic means

Skills

Key technologies and capabilities for this role

Clinical MonitoringRisk-Based MonitoringICH-GCPSite ManagementProtocol ComplianceRegulatory ComplianceRoot Cause AnalysisCritical ThinkingProblem-SolvingSOPs

Questions & Answers

Common questions about this position

Is this a remote position?

This is a home-based position, preferably based in Brisbane, Sydney, Adelaide, or Perth.

What are the key responsibilities of this CRA II role?

The role involves monitoring investigator sites using a risk-based approach, ensuring data accuracy through reviews, assessing investigational product inventory, documenting observations, escalating issues, and maintaining site contact to ensure protocol compliance.

What skills are needed for this position?

Key skills include root cause analysis, critical thinking, problem-solving, knowledge of ICH-GCP guidelines, protocol compliance, and site management processes.

What is the work schedule for this role?

The work schedule is standard Monday through Friday in an office environment.

What makes a strong candidate for this CRA II position?

A strong candidate demonstrates determination to deliver quality and accuracy, excels in clinical monitoring and site management, applies critical thinking and problem-solving to ensure compliance, and builds collaborative relationships with investigational sites.

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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