[Remote] Senior Clinical Research Associate - Central and West Coast (Cell & Gene Therapy) at Thermo Fisher Scientific

California, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Experienced Clinical Research Associate (CRA)
Knowledge of clinical monitoring and site management process
Risk-based monitoring approach
Root cause analysis (RCA)
Critical thinking and problem-solving skills
Data accuracy through SDR, SDV and CRF review
Investigational product assessment
Business writing standards
ICH-GCP and applicable regulations knowledge
Clinical Trial Management System experience
Communication skills (written, oral, electronic)

Responsibilities

Monitor investigator sites
Ensure data accuracy
Assess investigational products
Document observations in reports and letters
Escalate deficiencies and issues
Maintain contact with investigative sites
Conduct monitoring tasks according to the monitoring plan
Participate in the investigator payment process
Investigate and follow-up on findings
Participate in investigator meetings
Identify potential investigators
Initiate clinical trial sites
Perform trial close out and retrieval of trial materials
Ensure essential documents are complete
Conduct on-site file reviews
Provide trial status tracking and progress update reports
Update study systems
Facilitate communication between stakeholders
Respond to regulatory requirements/audits/inspections

Skills

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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