Assistant CRA at Thermo Fisher Scientific

Lisbon, Lisbon, Portugal

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Life SciencesIndustries

Requirements

Bachelor’s Degree in a life science-related field
Prior clinical research experience (0 years specified, entry-level)

Responsibilities

Develop and maintain close and collaborative communication with site staff, discussing protocol conduction, enrollment rates and strategies, open issues, EDC completion and queries, and other project status and site performance indicators
Complete/track/follow up ETRTR for subject data in EDC and other systems per study-specific guidelines; raise manual queries in EDC when applicable
Remotely review study logs as deemed necessary
Conduct and document site management calls/contacts according to the monitoring plan; participate in investigator meetings
Investigate and follow up on centralized monitoring findings
Evaluate PI oversight (e.g., protocol adherence), subject safety, and study processes to assess site’s ability to conduct the study regularly
Conduct remote investigations into site performance using risk-based monitoring approach, applying root cause analysis (RCA), critical thinking, and problem-solving to identify site process failures and implement corrective/preventive actions
Provide refresher training, follow up on outstanding administrative needs (e.g., regulatory documents), assist with regulatory reviews as requested
Review ad-hoc clinical listings, track and trend violations/deviations, site status, enrollment, CRF status, and SAE follow-up
Provide trial status tracking and progress update reports to study manager
Participate in investigator payment process if applicable
Liaise with internal staff to collect documents, review data points and findings from EDC and file reviews
Assist in ensuring audit-ready files and compliance with CTMS and eTMF data stewardship; contribute to company, client, and regulatory audit responses
Perform remote site management and monitoring activities on assigned projects in accordance with approved protocol, ICH-GCP, regulations, and PPD procedures by reviewing study data remotely
Contact study sites to collect documentation, resolve issues, and request outstanding information

Skills

ICH-GCP

EDC

Remote Monitoring

Site Management

Data Review

Protocol Compliance

Clinical Trials

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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