CRA, Ethiopia

Clinical Research Associate (CRA)

Ethiopia

Job Overview

As a Clinical Research Associate (CRA), you will perform site monitoring and management activities to ensure clinical studies are conducted in compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and sponsor expectations.

Key Responsibilities

• Conduct site qualification, initiation, routine monitoring, and close-out visits.

• Ensure protocol compliance, data quality, and patient safety at assigned sites.

• Support and track patient recruitment and enrollment activities.

• Deliver study-related training and maintain effective communication with site staff.

• Monitor study progress, including regulatory documentation, CRF completion, and query resolution.

• Review site documentation and ensure Trial Master File (TMF) and Investigator Site File (ISF) compliance.

• Document monitoring activities, findings, and follow-up actions through timely reports.

• Collaborate with project teams to support successful study execution.

• Support study start-up and site financial management activities, where applicable.

Qualifications and Knowledge

• Bachelor’s degree in a life science, healthcare, or related field preferred; equivalent education and experience considered.

• Minimum 2 years of independent on-site monitoring experience.

• Oncology therapeutic experience essential

• Working knowledge of ICH-GCP guidelines and clinical research regulations.

• Strong organizational, problem-solving, and time-management skills.

• Effective written and verbal communication skills in English.

• Proficiency with Microsoft Office applications and standard technology tools.

• Ability to build and maintain strong working relationships with sites, colleagues, and clients.