CRA (Level II) at Thermo Fisher Scientific

Sydney, New South Wales, Australia

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

Knowledge of ICH-GCP guidelines, applicable regulations, and SOPs
Ability to apply root cause analysis (RCA), critical thinking, and problem-solving skills
Familiarity with risk-based monitoring approaches, SDR, SDV, and CRF review
Skills in business writing standards for reports and letters
Experience managing procedures and guidelines from different sponsors/monitoring environments (e.g., FSO, FSP, Government)
Ability to ensure audit readiness and data reliability

Responsibilities

Performs and coordinates all aspects of clinical monitoring and site management
Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation
Acts as a site processes specialist, ensuring trial compliance with approved protocol, ICH-GCP, regulations, and SOPs
Monitors investigator sites using risk-based approach, identifying process failures and corrective/preventive actions
Ensures data accuracy through SDR, SDV, CRF review, physical inventory, and records review of investigational products
Documents observations in reports and letters timely using approved 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 monitoring tasks per approved monitoring plan
Participates in investigator payment process and shares responsibility for issues/findings resolution
Participates in investigator meetings as necessary
Identifies potential investigators in collaboration with client
Initiates clinical trial sites per procedures, ensuring compliance and making recommendations
Performs trial close out and retrieval of trial materials
Ensures essential documents are complete per ICH-GCP and regulations
Conducts on-site file reviews per project specifications
Provides trial status tracking and progress update reports to Clinical Team Manager (CTM)

Skills

Key technologies and capabilities for this role

Clinical MonitoringSite ManagementICH-GCPProtocol ComplianceRegulatory ComplianceSOPsAudit ReadinessClinical Trials

Questions & Answers

Common questions about this position

What is the work schedule for this CRA Level II position?

The work schedule is standard Monday through Friday.

Is this a remote position or does it require office work?

The position involves environmental conditions in an office and includes both remote and on-site visits to investigator sites.

What key skills are required for this CRA role?

Key skills include clinical monitoring, site management, root cause analysis, critical thinking, problem-solving, and ensuring compliance with protocols, ICH-GCP guidelines, regulations, and SOPs.

What is the company culture like at Thermo Fisher Scientific?

The culture emphasizes meaningful work with global impact, enabling customers to make the world healthier, cleaner, and safer, while providing resources for career goals and fostering collaborative relationships.

What makes a strong candidate for this CRA Level II position?

Strong candidates demonstrate determination to deliver quality and accuracy, expertise in risk-based monitoring, site process specialization, and skills in data review, issue escalation, and maintaining site compliance.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free