CRA (Level II) 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

Knowledge of protocol compliance, ICH-GCP guidelines, applicable regulations, and SOPs
Ability to apply root cause analysis (RCA), critical thinking, and problem-solving skills
Skills in data review (SDR, SDV, CRF) and ensuring data accuracy
Proficiency in documentation, report writing using approved business writing standards, and audit readiness
Experience managing procedures and guidelines from different sponsors/monitoring environments (e.g., FSO, FSP, Government)
Ability to develop collaborative relationships with investigational sites and act as a site processes specialist

Responsibilities

Performs and coordinates all aspects of clinical monitoring and site management, including remote or on-site visits to assess protocol and regulatory compliance and manage documentation
Monitors investigator sites using a risk-based approach, identifying site process failures and implementing corrective/preventive actions
Ensures data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring
Assesses investigational products via physical inventory and records review, documenting observations in reports and letters timely
Escalates deficiencies and 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 the approved monitoring plan and participates in investigator payment processes
Shares responsibility with project team on issues/findings resolution, investigating and following up as applicable
Participates in investigator meetings and identifies potential investigators in collaboration with clients
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, and provides trial status updates to CTM

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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