(Senior) Clinical Research Associate

Trial Form Support; La Spezia; Remote; EUR 52,000 - 68,000; Full time

Benefits offered by this job

Lunch vouchers

Health insurance

Pension

Car allowance

Job summary

Trial Form Support is seeking a remote Clinical Monitor to oversee oncology trials across sites, ensuring patient safety, data integrity, and regulatory compliance. You will coordinate monitoring activities, manage documentation, and participate in audits while supporting study conduct within a global, collaborative team.

The role requires a Bachelor's in Life Science or Nursing, 3+ years of trial monitoring (including early-phase), and willingness to travel up to 80% domestically and

Qualifications

• Bachelor's degree in Life Science, Nursing, or equivalent.
• At least 3 years of experience monitoring oncology trials (including at least one early-phase).
• Willingness to travel 60-80% domestically and abroad.
• Fluent in English with strong written and verbal communication skills.

Responsibilities

• 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.

Skills

Fluent English

GCP/ICH knowledge

CTMS proficiency

eTMF knowledge

Education

Bachelor's degree in Life Science or Nursing

Tools

CTMS

eTMF systems

Job description

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