Senior Oncology CRA - Remote, Global Trials

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

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.