Clinical Research Associate

Job Title : Clinical Research Associate

Department : Clinical Operations

Office Location : Remote, USA

Function :

The Clinical Research Associate is responsible for overseeing day-to-day operational aspects of assigned studies to ensure they are conducted in compliance with applicable regulatory requirements, study protocols, and company SOPs.

Responsibilities :

• Serve as the primary liaison for clinical sites, ensuring effective site management and communication.
• Conduct qualification, initiation, interim monitoring, and close-out visits according to the monitoring plan and applicable regulatory regulations.
• Verify that study data are collected, recorded, and reported accurately and in compliance with the protocol and Good Clinical Practice (GCP) guidelines.
• Identify and resolve site issues and protocol deviations in collaboration with the study team.
• Provide ongoing training and support to site staff to ensure adherence to study procedures and regulatory requirements.
• Maintain timely and complete monitoring documentation, including visit reports, follow-up letters, and tracking of action items.
• Assist with site selection, feasibility assessments, and contract / budget negotiations as needed.
• Participate in internal study team meetings and contribute to project planning and timeline management.
• Collaborate cross-functionally with data management, regulatory, safety, and other team members.
• Support audit and inspection readiness activities at sites and sponsor level.

Essential Experience :

Product Training Level :

Desirable Experience