Clinical Research Associate – Oncology Studies

Role Overview

• Perform monitoring and site management activities to ensure that clinical trial sites conduct studies and report data in accordance with the study protocol, applicable regulations, and sponsor requirements.
• Conduct site monitoring visits including site selection, initiation, routine monitoring, and close‑out visits in line with contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
• Work closely with sites to adapt, drive, and track subject recruitment plans to support project timelines and predictability.
• Deliver protocol, study‑specific, and ongoing training to investigative sites and maintain regular communication to manage expectations and address issues.
• Evaluate the quality and integrity of site practices related to protocol compliance, patient safety, and regulatory adherence; escalate quality issues when necessary.
• Manage study progress by tracking regulatory submissions and approvals, enrollment status, CRF completion, and data query resolution; may support study start‑up activities when required.
• Ensure essential documents are complete and properly filed within the Trial Master File (TMF) and verify that the Investigator Site File (ISF) is maintained in compliance with GCP, ICH, and local regulatory requirements.
• Prepare and maintain accurate and timely documentation, including monitoring visit reports, follow‑up letters, and action plans.
• Collaborate effectively with cross‑functional study team members to support overall project delivery.
• Where applicable, support site‑level subject recruitment strategies and site financial management in line with Clinical Trial Agreements and local requirements.

Requirements

• Minimum 6 months of on-site monitoring experience in oncology clinical studies is required.
• Previous CRA experience is required.
• Solid understanding of clinical research regulations, including GCP and ICH guidelines.
• Strong therapeutic and protocol knowledge, supported by company-provided training.
• Proficiency in Microsoft Word, Excel, and PowerPoint; ability to work effectively using a laptop and mobile devices.
• Strong written and verbal communication skills, including a good command of English.
• Excellent organizational, time management, and problem-solving skills.
• Ability to establish and maintain effective working relationships with colleagues, line managers, and external stakeholders.

Tech Stack

• Google Cloud Platform

Benefits

• Professional development opportunities