Senior CRA - Phase I oncology trials - Hamburg/Berlin region

Overview

Senior CRA role for Phase I oncology trials covering the Hamburg/Berlin region, supporting site monitoring and compliance with ICH-GCP and protocol requirements.

What you'll do

• Perform source data verification, investigational product accountability, and protocol compliance checks.
• Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely).
• Review site processes, conduct Source Document Review, and verify CRF accuracy and completeness.
• Resolve CRF queries remotely and on-site and guide site staff toward closure timelines.
• Assess factors impacting subject/patient safety and clinical data integrity; escalate serious issues.
• Verify electronic data capture compliance and maintain Investigator Site File (ISF) accuracy and completeness.

What you'll need

• Experience as a CRA with oncology clinical trials across phases, including early phase/first-in-human studies.
• Knowledge of Good Clinical Practice (ICH) guidelines and applicable regulatory requirements.
• Strong computer skills and ability to embrace new technologies.
• Comfort supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer.
• Ability to manage required travel of up to 75% on a regular basis.
• Excellent communication, presentation, and interpersonal skills.

Details

• Work mode: Remote (DEU-Remote).
• Location focus: Hamburg/Berlin region.