Clinical Research Associate (Life Sciences, Remote)

Job summary

This role involves managing clinical trial sites to ensure compliance with regulatory standards and protocol adherence, while supporting the overall success of clinical studies.

Qualifications

• Experience in clinical research and site management.
• Knowledge of ICH-GCP guidelines and relevant regulations.

Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits, ensuring compliance with regulatory and protocol requirements.
• Verify informed consent processes and protect subject confidentiality.
• Assess site processes and conduct source document reviews for data accuracy.
• Manage investigational product inventory and ensure proper handling according to protocols.
• Review and reconcile Investigator Site Files with Trial Master Files for completeness.
• Document activities and support subject recruitment and retention strategies.
• Act as a liaison with study site personnel and ensure compliance with training requirements.
• Prepare for and attend investigator meetings and support audit readiness.
• Provide mentorship and training to junior CRAs as needed.

Skills

• Strong organizational and communication skills.
• Ability to adapt to changing priorities and manage multiple tasks.

Education

• Relevant degree in life sciences or related field preferred.

Tools

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