[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 using risk-based approach
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/completes administrative tasks (e.g., expense reports, timesheets) timely
Contributes to project team via preparation of publications/tools, sharing ideas, process improvement, and other initiatives
Travel requirement higher than 75%

Responsibilities

Monitors investigator sites with risk-based approach, applying RCA, critical thinking, and problem-solving to ensure compliance and reduce risks
Ensures data accuracy via SDR, SDV, CRF review through on-site/remote activities
Assesses investigational product accountability
Documents site observations timely in reports/letters
Escalates and resolves site deficiencies/issues
Maintains site contact between visits for protocol compliance and data timeliness
Executes monitoring per approved plan
Participates in investigator payments
Collaborates on issue resolution and follow-up
Attends investigator meetings
Assists in investigator/site selection
Initiates sites ensuring GCP/protocol compliance
Conducts site close-out and material retrieval
Manages essential documents and file reviews
Tracks and reports trial progress
Maintains study systems accuracy
Facilitates site-client-team communication
Handles audits/inspections
Completes administrative tasks timely
Contributes to team projects, tools, and improvements

Skills

Risk-Based Monitoring

Root Cause Analysis

ICH GCP

SDV

SDR

CRF Review

Site Initiation

Site Closeout

Investigator Meetings

Essential Documents

Clinical Trial Monitoring

Protocol 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.

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