Clinical Research Associate – Immunology (Remote)

About the role

The Clinical Research Associate (CRA) will manage immunology study sites across the Southwest, Northwest and Rocky Mountain regions, ensuring compliance with ICH/GCP, sponsor SOPs and local regulations. The role involves both remote and on‑site monitoring, site relationship development and contribution to territory expansion.

Key responsibilities

• Develop and maintain strong site relationships throughout all trial phases, acting as the primary site contact.
• Perform remote and on‑site monitoring visits, including validation, initiation, routine monitoring and close‑out visits, and document findings accurately.
• Collect, review and manage regulatory documentation for study start‑up, maintenance and close‑out in CTMS and eTMF systems.
• Identify, assess and resolve site performance or compliance issues, escalating when necessary.
• Support audit/inspection activities and contribute as a subject‑matter expert for monitoring processes.

Required profile

• Associate’s degree with at least 5 years of healthcare experience (including 2 years site monitoring) or a Bachelor’s degree with 2 years monitoring experience.
• Strong understanding of clinical research, GCP/ICH guidelines and regulatory requirements.
• Excellent communication skills in English and ability to work independently across multiple protocols.
• Willingness to travel 65‑75% of the time (approximately 2‑3 days per week).

Required skills

• Adverse Event Reporting System
• Clinical Research, Clinical Research Methods
• Clinical Site Management, Clinical Study Management
• Clinical Trial Planning, Clinical Trials Monitoring
• Document Management, Good Clinical Data Management Practice (GCDMP)
• Good Clinical Practice (GCP)
• Matrix Management, On‑Site Management
• Pharmaceutics, Protocol Adherence, Protocol Review
• Regulatory Affairs Management, Regulatory Compliance, Regulatory Inspections
• Relationship Building, Remote Monitoring, Site Management, Study Design