Offer summary

Qualifications:

Minimum 2 years of clinical monitoring experience, with at least 1 year in Oncology., Strong understanding of regulatory requirements and drug development processes., Excellent site management and monitoring skills, including registry administration., Fluent in Spanish and English, with strong communication skills..

Key responsibilities:

Oversee site activities to ensure compliance with GCP guidelines and study protocols.

Manage site visits, including pre-study, initiation, and close-out visits.

Ensure regulatory compliance and data integrity through source document reviews and query resolution.

Maintain accurate study documentation and monitor investigational product inventory.

Job description

Join Fortrea as a Clinical Research Associate (CRA2) – Drive Clinical Excellence in Oncology Trials.

Job Overview

We are looking for a CRA II to join our FSP Team with studies located in Andalucia. Home based in Andalucia, with preference in Malaga is mandatory:

You will ensure clinical studies are conducted to the highest regulatory and quality standards, protecting patient safety and delivering reliable data. You’ll have the autonomy to manage sites and drive study outcomes while contributing to innovative research in critical therapeutic areas. Your work will help shape the future of clinical research and provide life-changing treatments to patients worldwide.

Summary of Responsibilities:

Lead Site Management: You will oversee site activities to ensure compliance with ICH GCP guidelines, study protocols, and sponsor requirements.
Conduct Site Monitoring Visits: Manage pre-study, initiation, routine, and close-out visits to verify data accuracy and study progress.
Ensure Regulatory Compliance: Confirm informed consent procedures, monitor adverse events, and ensure site readiness for audits.
Safeguard Data Integrity: Perform meticulous source document reviews and eCRF verifications to ensure data accuracy and resolution of queries.
Manage Study Documentation: Maintain complete, current site regulatory documents and eTMF/Sponsor records throughout the trial.
Investigational Product Accountability: Monitor investigational product inventory and secure storage per protocol.
Drive Study Timelines: Align site activities with key milestones to meet critical project deliverables efficiently.

Qualifications:

2+ years of clinical monitoring experience, including Oncology therapeutic areas for minimum 1 year.
Strong knowledge of regulatory and drug development processes.
Advanced site monitoring, site management, and registry administration skills.
Fluent in Spanish language and English, with excellent written and verbal communication.

Work Environment:

60-80% overnight travel, valid driver’s license required.

Benefits:

At Fortrea, we value our team members and offer a comprehensive benefits package, including competitive compensation, health and wellness programs, and opportunities for professional growth. You’ll also enjoy flexible work arrangements and the chance to make a meaningful impact in cutting-edge clinical research.

Your Contribution to Fortrea’ s Success:
In this role, you will help ensure the smooth execution of clinical trials and play a key role in delivering high-quality data and compliance. Your efforts will contribute directly to Fortrea’s mission of advancing clinical research and improving global health outcomes. Ready to make an impact? Join us!

Learn more about our EEO & Accommodations request here.

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