[Remote] Clinical Research Associate (Level II) - FSP Oncology - Texas at Thermo Fisher Scientific

Texas, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

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Requirements

Bachelor's degree in a life science or related field
1-2 years of experience in clinical research or a related field
Experience with clinical trials and GCP regulations
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
Strong organizational and time management skills
Proficiency in Microsoft Office and clinical trial management systems

Responsibilities

Monitor investigator sites with a risk-based approach
Conduct on-site and remote monitoring activities
Review data accuracy through SDR, SDV, and CRF review
Assess investigational product through physical inventory and records review
Document observations in reports and letters
Escalate observed deficiencies and issues to clinical management
Maintain regular contact with investigative sites to confirm compliance and data accuracy
Conduct monitoring tasks in accordance with the approved monitoring plan
Participate in investigator payment process
Investigate and follow-up on findings
Participate in investigator meetings
Identify potential investigators and ensure site acceptability
Initiate clinical trial sites according to procedures
Perform trial close out and retrieval of trial materials
Ensure required documents are complete and in place
Conduct on-site file reviews
Provide trial status tracking and progress update reports
Update study systems per agreed study conventions
Facilitate communication between sites, client company, and project team
Respond to company, client, and regulatory requirements/audits/inspections
Complete administrative tasks such as expense reports and timesheets
Contribute to project team by assisting in preparation of project publications/tools
Contribute to process improvement initiatives

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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