About the Role Our client, a leading pharmaceutical research organization with a significant presence in Queenstown, Eastern Cape, is seeking a highly experienced Senior Clinical Research Associate (CRA) to join their dynamic team.

This role is instrumental in ensuring the successful execution of clinical trials by monitoring study sites, ensuring data integrity, and maintaining compliance with regulatory standards.

The idóneo candidate will possess extensive knowledge of clinical trial processes, a strong understanding of Good Clinical Practice (GCP) guidelines, and exceptional organizational skills.

This position offers a hybrid work arrangement, combining essential on-site monitoring visits with remote site management and administrative tasks.

You will play a crucial role in advancing medical research and bringing life-changing therapies to patients.

Key Responsibilities * Conduct pre-study, initiation, routine monitoring, and close-out visits for clinical trial sites. * Ensure the quality, integrity, and accuracy of study data collected at assigned sites. * Verify that sites are in compliance with the study protocol, Good Clinical Practice (GCP), and applicable regulations. * Manage relationships with principal investigators and site staff, providing necessary support and guidance. * Prepare visit reports and follow up on action items to ensure timely resolution of site issues. * Identify and elevate potential study risks and challenges to the Clinical Trial Manager. * Ensure timely submission of essential regulatory documents from study sites. * Participate in protocol development and study-related training as required. * Maintain accurate and up-to-date study documentation in the Trial Master File (TMF).



* Communicate effectively with internal teams, including project managers, data managers, and medical monitors.

Requirements * A minimum of 5 years of direct experience as a Clinical Research Associate, with demonstrated success in monitoring multiple clinical trials. * In-depth knowledge of ICH-GCP guidelines and other relevant regulatory requirements. * Proven experience in site management, including patient recruitment strategies and retention efforts. * Strong understanding of clinical trial protocols and medical terminology. * Excellent organizational, time management, and problem-solving skills. * Exceptional written and verbal communication skills. * Ability to travel extensively to assigned clinical trial sites, predominantly within the Eastern Cape region, with occasional travel to other provinces. * Proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems. * A Bachelor's degree in a life science, nursing, or related healthcare field is required. * Advanced degrees or certifications are advantageous. * Demonstrated ability to work independently and as part of a remote and on-site team.

Benefits * Our client offers a highly competitive salary, commensurate with experience, and a performance-based bonus structure. * Comprehensive medical aid, life insurance, and a robust retirement fund are provided. * Generous travel allowances and per diems are included for site visit expenses. * Opportunities for professional development, including advanced certifications and training, are readily available. * Enjoy the flexibility of a hybrid work model and contribute to groundbreaking medical advancements from a strategically located base. #J-18808-Ljbffr

📌 Senior Clinical Research Associate (CRA) (Galicia)
🏢 Placements24
📍 Galicia