Clinical Research Associate II/Sr CRA I (Remote)

Job summary

This role involves managing clinical trial sites, ensuring compliance with regulatory standards, and supporting the overall clinical study lifecycle. The position is fully remote and focuses on maintaining high standards of clinical data integrity and patient safety.

Qualifications

• Experience in clinical research, specifically in site management and monitoring.
• Strong understanding of ICH/GCP guidelines and relevant regulations.
• Proven ability to manage multiple priorities and adapt to changing project needs.

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 processes and source documents, ensuring data accuracy and completeness.
• Manage investigational product inventory and compliance with protocols.
• Maintain accurate documentation and support patient recruitment strategies.
• Act as a liaison with study site personnel and ensure training compliance.
• Prepare for and participate in investigator meetings and audits.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal abilities.
• Proficient in using clinical trial management software and electronic data capture systems.

Education

• Relevant degree in life sciences or a related field.

Tools

• Clinical trial management systems, electronic data capture tools, and standard office software.