Senior Clinical Research Associate (Pharmaceutical, Remote)

Job summary

This role involves overseeing clinical trial sites to ensure compliance with regulatory standards and protocols, performing site management tasks, and supporting the overall success of clinical studies. The position requires a strong understanding of Good Clinical Practice (GCP) and the ability to manage site-level activities effectively.

Qualifications

• Experience in clinical research, preferably as a CRA II or Sr CRA I.
• Knowledge of ICH/GCP guidelines and relevant regulations.
• Ability to assess site performance and communicate effectively with site staff.

Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits, ensuring compliance with protocols and regulations.
• Verify informed consent processes and protect patient confidentiality.
• Review site source documents and ensure accuracy of clinical data in case report forms.
• Manage investigational product inventory and compliance with protocols.
• Maintain accurate documentation of site activities and communications.
• Support patient recruitment and retention strategies.
• Act as a liaison with site personnel and ensure training compliance.
• Participate in investigator meetings and support audit readiness.
• Provide mentorship to junior CRAs as needed.

Skills

• Strong organizational and communication skills.
• Ability to adapt to changing priorities and manage multiple tasks.
• Proficiency in data management and electronic data capture systems.

Education

• Relevant degree in life sciences or a related field is preferred.

Tools

• Familiarity with clinical trial management systems and electronic data capture tools.