Overview
In this home-based role, you will monitor clinical trials in oncology across sites, ensuring patient safety, data integrity, and regulatory compliance. You'll work within the Strategic Resourcing Solutions team to support study conduct, site management, and quality by adhering to GCP/ICH and SOPs. You'll coordinate monitoring activities, manage documentation, and participate in audits, enabling successful study execution. This position offers global collaboration, travel, and opportunities to contribute to meaningful patient outcomes.

Retribuzione / Benefits

competitive compensation package

lunch vouchers

health insurance

pension

car allowance where applicable

Responsabilità

Monitor on-site and remote trials per SOPs, GCP/ICH and regulations

Ensure patient safety, data integrity, and quality through monitoring activities

Verify informed consent and protocol adherence

Review CRFs and source data for accuracy

Manage Investigational Product accountability

Report monitoring findings and CAPA actions; update tracking systems

Provide sites with issue lists and timely action items





Ensure timely delivery of documents to eTMF/paper TMF; maintain ISF per regulations

Participate in audits/inspections preparation and follow-up

Order, ship, and reconcile clinical supplies if applicable

Update CTMS and project systems with site information

Requisiti fondamentali

Bachelor's Degree in Life Science or Nursing or equivalent

At least 3 years of experience monitoring clinical trials in Oncology (including at least one early-phase study)

Ability to work in fast-paced environments with changing priorities

Strong understanding of medical terminology and pharmacology of assigned drugs

Knowledge of GCP, ICH guidelines, and regulatory requirements

Ability to work independently and in a matrix team

Strong written and verbal communication skills

Fluent in English

Excellent organizational skills

Tech-savvy with good computer skills

Willingness to travel 60-80% domestically and abroad

Self-awareness

flexibility

proactivity

GCP/ICH knowledge

CTMS proficiency

eTMF knowledge

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📌 (Senior) Clinical Research Associate (Cremona)
🏢 Altro
📍 Cremona