[Remote] CRA (Level II) at Thermo Fisher Scientific

Brazil

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Applies root cause analysis (RCA), critical thinking and problem-solving skills
Monitors investigator sites with a risk-based monitoring approach
Ensures compliance with protocol, regulatory and ICH GCP obligations
Conducts on-site and remote monitoring activities (SDR, SDV, CRF review)
Assesses investigational product through physical inventory and records review
Documents observations in reports and letters using approved business writing standards
Maintains regular contact with sites between visits
Participates in investigator meetings and site initiation/close-out
Updates study systems (e.g., CTMS) per conventions
Performs QC checks on CTMS reports
Responds to company, client, and regulatory requirements/audits/inspections
Maintains and completes administrative tasks (e.g., expense reports, timesheets)

Responsibilities

Monitors investigator sites, identifies process failures, and implements corrective/preventive actions
Ensures data accuracy through source data review (SDR), source data verification (SDV), and case report form (CRF) review
Documents observations and issues in reports/letters timely and escalates to clinical management for resolution
Conducts monitoring tasks per approved monitoring plan
Participates in investigator payment process and issues/findings resolution with project team
Investigates and follows up on findings
Provides trial status tracking and progress updates to Clinical Team Manager (CTM)
Identifies potential investigators and ensures acceptability of sites in collaboration with client
Initiates clinical trial sites, conducts on-site file reviews, and ensures essential documents are complete
Ensures trial close-out and retrieval of materials
Assists in preparation of project publications/tools, shares ideas, and performs additional tasks assigned by CTM (e.g., trip report review, newsletter creation)
Facilitates communication between sites, client, and project team
Contributes to other project work and process improvement initiatives

Skills

Key technologies and capabilities for this role

Risk-Based MonitoringRoot Cause AnalysisCritical ThinkingICH GCPSDVSDRCRF ReviewCTMSClinical Trial ManagementInvestigator Site MonitoringProtocol ComplianceRegulatory Compliance

Questions & Answers

Common questions about this position

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

This is an office-based role with on-site and remote monitoring activities, conducted in an office environment under standard Monday-Friday schedule.

What key skills are required for the CRA (Level II) role?

The role requires risk-based monitoring, root cause analysis (RCA), critical thinking, problem-solving skills, and knowledge of ICH GCP, regulatory obligations, and clinical trial processes.

What is the salary or compensation for this position?

This information is not specified in the job description.

What does the team collaboration look like in this role?

The role involves shared responsibility with project team members on issue resolution, facilitating communication between sites, client, and PPD project team, and contributing ideas to the team including assisting with publications/tools.

What makes a strong candidate for this CRA position?

Strong candidates demonstrate experience in site monitoring, data review (SDR, SDV, CRF), protocol compliance, ICH-GCP knowledge, and effective communication with sites and 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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