KCR
Clinical Monitoring • Functional Service Provider • Site Set up and Contracting • Late Phase • Medical & Regulatory Affairs
Clinical Research Associate
December 7
KCR
Clinical Monitoring • Functional Service Provider • Site Set up and Contracting • Late Phase • Medical & Regulatory Affairs
Description
• Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations • Conduct Investigator Profile and Clinical Site Initiation visits as well as Clinical Site Close-Out visits for studies of all phases in a range of different indications. • Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans • Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process • Ensures appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs) • Assist in preparing sites for audits, review audit reports and contributes to resolve findings • Build and maintain solid and long-term professional relationships with investigators and site staff
Requirements
• BA/BS/BSc degree or similar • Familiarity with ICH/GCP guidelines plus local codes of practice as applicable • Experience or Training working as a CRA • Proficiency in English • Willingness to travel • Good working knowledge of common software packages • Flexibility and Team skills
Benefits
• 1 additional day off for your birthday • Onboarding process and induction training to develop deep sector knowledge and complex skills • Latest technology and the most advanced equipment and working tools • An open culture based on slim processes, in an agile structure with a flat hierarchy and direct access to the Management to share ideas and implement change and continuous improvement • Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills
Apply Now