Remote Oncology Clinical Research Associate — Global Trials

Trial Form Support; La Spezia; Remote; EUR 52.000 - 68.000; Vollzeit

Benefits dieser Stelle

Lunch vouchers

Health insurance

Pension

Car allowance

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Fluent English

GCP/ICH knowledge

CTMS proficiency

eTMF knowledge

Ausbildung

Bachelor's degree in Life Science or Nursing

Tools

CTMS

eTMF systems

Jobbeschreibung

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