[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, PharmaceuticalsIndustries

Requirements

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

Responsibilities

Monitors investigator sites using risk-based approach, identifying process failures and implementing corrective/preventive actions
Ensures data accuracy through SDR, SDV, and CRF review via on-site and remote activities
Assesses investigational product through 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 approved monitoring plan
Participates in investigator payment process
Shares responsibility with project team on issues/findings resolution and investigates/follows up as applicable
Provides trial status tracking and progress update reports to Clinical Team Manager (CTM)
Updates study systems (e.g., CTMS) per conventions and performs QC checks on CTMS reports
Participates in investigator meetings as necessary
Identifies potential investigators in collaboration with client to ensure qualified sites
Initiates clinical trial sites per procedures, ensuring protocol, regulatory, and ICH-GCP compliance, with recommendations
Ensures trial close-out and retrieval of trial materials
Ensures essential documents are complete per ICH-GCP and regulations; conducts on-site file reviews
Contributes to project team by assisting in project publications/tools and sharing ideas
Performs additional study tasks assigned by CTM (e.g., trip report review, newsletter creation, lead CRA team calls)
Facilitates communication between sites, client, and PPD project team 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 other project work and process improvement initiatives

Skills

Key technologies and capabilities for this role

Risk-Based MonitoringRoot Cause AnalysisCritical ThinkingICH GCPSDVSDRCRF ReviewCTMSSite InitiationSite CloseoutInvestigator MeetingsProtocol ComplianceRegulatory Compliance

Questions & Answers

Common questions about this position

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

The role involves environmental conditions listed as office and requires on-site monitoring activities at investigator sites, though remote monitoring is also mentioned.

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

Key skills include root cause analysis (RCA), critical thinking, problem-solving, data review through SDR/SDV/CRF, and knowledge of ICH GCP regulations.

What is the salary or compensation for this position?

This information is not specified in the job description.

What does the work schedule look like for this job?

It is a full-time position with a standard Monday-Friday work schedule.

What makes a strong candidate for this Sr CRA role?

Strong candidates demonstrate experience in risk-based monitoring, site management, regulatory compliance with ICH GCP, effective communication, and problem-solving to resolve site issues.

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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