[Remote] Assistant CRA at Thermo Fisher Scientific

Mexico

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

Requirements

Bachelor’s Degree in a life science-related field
Prior clinical research experience 0-1 year
Knowledge of clinical monitoring through classwork/training that provides the required knowledge, skills, and abilities
In some cases, previous experience in a clinical environment (e.g., clinical trials, data management, medical terminology, medical research, health care) or in a health sciences field with formal training in medical terminology and anatomy
Aspiration to advance into a CRA role (preferred)

Responsibilities

Develops and maintains close and collaborative communication with site staff, discussing protocol conduction, enrollment rates and strategies, open issues, EDC completion and queries, project status, and site performance
Completes/tracks/follows up ETRTR for subject data in EDC and other systems per study-specific guidelines; raises manual queries in EDC when applicable
Remotely reviews study logs as deemed necessary
Conducts and documents site management calls/contacts according to the monitoring plan; participates in investigator meetings
Investigates and follows up on centralized monitoring findings
Evaluates PI oversight (e.g., protocol adherence), subject safety, and study processes to assess site’s ability to conduct the study
Conducts remote investigations into site performance using risk-based monitoring (root cause analysis, critical thinking, problem-solving) to identify process failures and implement corrective/preventive actions
Provides refresher training, follows up on outstanding administrative needs (e.g., regulatory documents), assists with regulatory reviews
Reviews ad-hoc clinical listings, tracks/trends violations and deviations, site status, enrollment, CRF status, and SAE follow-up
Provides trial status tracking and progress update reports to study manager
Participates in the investigator payment process, if applicable
Liaises with internal staff to collect documents, review data points and findings from EDC and file reviews
Assists in ensuring audit-ready files and compliance with CTMS and eTMF data stewardship; contributes to company, client, and regulatory audit responses
Follows detailed task assignments and responsibilities outlined in the task matrix and applicable protocol guidelines

Skills

Clinical Research

Clinical Monitoring

EDC

Site Management

Risk Based Monitoring

Root Cause Analysis

Protocol Adherence

Data Management

Medical Terminology

Investigator Meetings

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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