[Remote] Sr CRA (Level I) at Thermo Fisher Scientific

Argentina

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

Knowledge of risk-based monitoring approach, root cause analysis (RCA), critical thinking, and problem-solving skills
Familiarity with data accuracy processes including SDR, SDV, and CRF review
Understanding of ICH-GCP and applicable regulations
Proficiency in approved business writing standards for reports and letters
Ability to conduct on-site and remote monitoring activities
Experience with Clinical Trial Management System (CTMS) and study systems updates
Skills in physical inventory and records review for investigational products

Responsibilities

Monitors investigator sites using a risk-based approach, applying RCA to identify site process failures and implement corrective/preventive actions
Ensures data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring
Assesses investigational product via physical inventory and records review
Documents observations in reports and letters timely using approved standards
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
Participates in the investigator payment process
Shares responsibility with project team on issues/findings resolution and investigates/follows up on findings
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM)
Updates study systems (e.g., CTMS) per agreed conventions and performs QC checks on CTMS reports
Participates in investigator meetings as necessary
Identifies potential investigators in collaboration with the client to ensure qualified sites
Initiates clinical trial sites per procedures, ensuring compliance with protocol, regulatory, and ICH-GCP obligations, with recommendations as needed
Ensures trial close-out and retrieval of trial materials
Verifies essential documents are complete per ICH-GCP and regulations, conducting on-site file reviews
Contributes to the project team by assisting in preparation of publications/tools and sharing ideas/suggestions

Skills

Key technologies and capabilities for this role

Risk-Based MonitoringRoot Cause AnalysisCritical ThinkingProblem-SolvingSDVSDRCRF ReviewICH GCPCTMSClinical Trial ManagementInvestigator Site MonitoringProtocol ComplianceData Accuracy

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

The role involves both on-site and remote monitoring activities at investigator sites, conducted in an office environment with a standard Monday-Friday schedule.

What are the key skills required for the Sr CRA role?

Key skills include risk-based monitoring, root cause analysis (RCA), critical thinking, problem-solving, data accuracy review via SDR/SDV/CRF, and business writing standards.

What is the salary or compensation for this position?

This information is not specified in the job description.

What are the employment details like work schedule and type?

This is a full-time position with a standard Monday-Friday work schedule in an office environment.

What experience or qualities make a strong candidate for this CRA role?

Strong candidates will have experience in clinical research monitoring, knowledge of ICH-GCP regulations, skills in site initiation/close-out, issue escalation, and collaboration with project teams.

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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