[Remote] FSP CRA Level I at Thermo Fisher Scientific

Brazil

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, PharmaceuticalsIndustries

Requirements

Applies root cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and corrective/preventive actions
Ensures data accuracy through source data review (SDR), source data verification (SDV), and case report form (CRF) review via on-site and remote monitoring
Assesses investigational product through physical inventory and records review
Documents observations in reports and letters timely using approved business writing standards
Escalates deficiencies and issues to clinical management expeditiously 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
Shares responsibility with project team on issues/findings resolution and investigates/follows up as applicable
Participates in investigator meetings as necessary
Helps identify potential investigators in collaboration with client to ensure qualified sites
Initiates clinical trial sites per procedures to ensure compliance with protocol, regulatory, and ICH GCP obligations, 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 specs
Provides trial status tracking and progress update reports
Ensures study systems (e.g., Clinical Trial Management System) are complete, accurate, and updated
Facilitates communication between sites, client, and internal teams via written, oral, or electronic means
Responds to company, client, and regulatory requirements/audits/inspections
Maintains and completes administrative tasks (e.g., expense reports, timesheets) timely
Contributes to project team by assisting in project publications/tools, sharing ideas, and process improvement initiatives
Travel requirement higher than 75%

Responsibilities

Monitors investigator sites using risk-based monitoring approach
Brings sites into compliance and decreases risks
Conducts on-site and remote monitoring activities
Follows all issues through to resolution
Conducts monitoring per approved plan
Participates in investigator payment process and issues resolution
Investigates and follows up on findings
Participates in investigator meetings
Identifies potential investigators with client
Initiates sites ensuring compliance
Performs trial close-out and material retrieval
Ensures essential documents are in place and conducts file reviews
Tracks and reports trial status/progress
Updates study systems per conventions
Facilitates communication between stakeholders
Responds to audits/inspections
Completes administrative tasks
Contributes to project team efforts and process improvements

Skills

Key technologies and capabilities for this role

Risk-Based MonitoringRoot Cause AnalysisICH GCPSDVSDRCRF ReviewSite InitiationTrial CloseoutInvestigator MeetingsEssential Documents

Questions & Answers

Common questions about this position

What is the work schedule for this FSP CRA Level I position?

The work schedule is standard Monday through Friday.

What is the travel requirement for this role?

The position requires travel higher than 75%.

What key skills are needed for this CRA position?

Key skills include root cause analysis, critical thinking, problem-solving, risk-based monitoring, and knowledge of ICH GCP regulations.

Is this a remote position or office-based?

The role is office-based with environmental conditions listed as office and high travel requirements.

What experience or qualifications make a strong candidate for this role?

Strong candidates have experience in clinical research monitoring, site management, data review, regulatory compliance, and the ability to travel over 75%.

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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