To ensure the integrity and regulatory compliance of clinical studies conducted in one or multiple countries. The Clinical Research Associate (CRA) is responsible for site monitoring activities, data quality verification, and adherence to study protocols, ICH GCP standards, SOPs, and local regulatory requirements.
Key Responsibilities Include:
• Oversee clinical trial conduct to ensure protocol and regulatory compliance.
• Monitor data quality and site performance; resolve issues as needed.
• Participate in the development and review of protocols, CRFs, and informed consent forms.
• Assist with submissions to Ethics Committees and Regulatory Authorities.
• Support investigational site agreement, budget negotiations, and site payment coordination.
• Conduct Qualification, Site Initiation, Monitoring, and Close-Out Visits.
• Ensure subject rights, safety, and well-being are protected throughout the trial.
• Track subject enrollment, support recruitment strategies, and manage study supplies.
• Prepare detailed monitoring visit reports and maintain accurate documentation.
• Ensure clear communication with clinical study teams and site staff.
• Attend necessary trainings, investigator meetings, and support audit readiness.