Clinical Research Associate

Position Mission :

Responsible for monitoring study progress, training sites, reviewing data, and ensuring site engagement and patient safety.

Key Responsibilities :

• Conduct qualification, initiation, monitoring, and close-out visits at designated research sites.
• Ensure that clinical studies are conducted in accordance with protocols, Good Clinical Practices (ICH-GCP), and local regulatory requirements.
• Prepare, review, and collect all required regulatory documentation before, during, and after site visits.
• Oversee study integrity and safeguard participants’ rights and well-being.
• Manage investigator files, ensuring they are complete, updated, and properly organized.
• Verify randomization procedures, blinding, and drug accountability according to protocol.
• Ensure proper acquisition of informed consent from participants.
• Support audits and inspections, coordinating requirements between sites, auditors, and sponsors.
• Act as the point of contact between investigators, sponsors, and project teams.
• Support site staff training and contribute to the development of new CRAs.
• Participate in meetings, courses, and training sessions for ongoing technical development.
• Comply with all regulations, SOPs, and quality and ethical standards.
• Assist with investigator payments and participant reimbursements.
• Collaborate with the regulatory team on submissions to authorities and ethics committees.

Academic Background :

Languages :

Experience Required :