Job
Description
Role Overview: As a Clinical Research Associate (CRA), you will be responsible for performance and compliance for assigned protocols and sites in a specific country. Under the guidance of the CRA-Manager, you will ensure the adherence of study conduct to ICH/GCP and country regulations, company policies and procedures, quality standards, and reporting requirements for adverse events internally and externally. Your primary role will involve acting as the main point of contact and site manager throughout all stages of a clinical research study, assuming overall responsibility for allocated sites. You will actively contribute to the development and expansion of the territory for clinical research by identifying and nurturing new sites. Additionally, you will participate in internal meetings and workstreams as a Subject Matter Expert (SME) for monitoring processes and systems. Key Responsibilities: - Develop strong relationships with sites and maintain continuity through all trial phases. - Conduct clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents. - Gain a comprehensive understanding of the study protocol and related procedures. - Coordinate and manage tasks collaboratively with other sponsor roles to achieve Site Ready status. - Provide inputs on site selection and validation activities. - Perform remote and on-site monitoring and oversight activities to ensure data accuracy, subject safety, and protocol adherence. - Conduct various site visits and document visit reports timely and accurately. - Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out. - Communicate effectively with Investigators and site staff on protocol-related issues, recruitment, deviations, audits, and overall site performance. - Identify, assess, and resolve site performance, quality, or compliance issues and escalate when necessary. - Collaborate with various internal and external stakeholders to support assigned sites. - Manage information and documentation in relevant systems and contribute to CRA team knowledge sharing. - Support audit/inspection activities and perform co-monitoring visits as required. - Contribute to identifying new potential sites in alignment with the country strategy defined by CRD and/or CRA-Manager. Qualification Required: - Fluent in Local Languages and English with excellent communication skills. - Good understanding of clinical research, GCP/ICH guidelines, and local clinical research regulations. - Hands-on knowledge of Good Documentation Practices. - Skills in Site Management, patient recruitment, and monitoring. - Proficient in IT applications and data analysis. - Ability to manage complex issues, work independently, and prioritize tasks effectively. - Strong interpersonal skills, conflict management, and problem-solving abilities. - Demonstrated professionalism, accountability, and commitment to high quality and compliance standards. Additional Company Details: N/A,
