(Senior) Clinical Research Associate

Trial Form Support; Venezia; Remote; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Lunch vouchers

Health insurance

Pension

Car allowance where applicable

Job summary

Trial Form Support seeks a capable Clinical Trial Monitor to oversee oncology trials across sites, ensuring patient safety, data integrity, and regulatory compliance from a home-based setting. You will coordinate monitoring activities, manage documentation, and support audits to enable successful study execution.

The role requires at least 3 years in monitoring oncology trials (including early-phase), strong GCP/ICH knowledge, and fluency in English.

Qualifications

• 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.
• Willingness to travel 60-80% domestically and abroad.

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

English fluency

Communication

Organization

Adaptability

Proactivity

Independent work

GCP/ICH knowledge

CTMS proficiency

eTMF knowledge

Travel readiness

Education

Bachelor's Degree in Life Science or Nursing or equivalent

Tools

CTMS

eTMF

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