Clinical Research Associate; CRA; Immunology-Remote

The Clinical Site Manager oversees performance and compliance of assigned clinical trial sites across specified U.S. states, ensuring adherence to ICH-GCP, local regulations, and company policies throughout all trial phases.

• Developing strong site relationships
• Managing site activities
• Participant recruitment
• Regulatory documentation
• Oversight through remote and onsite monitoring, including validation, initiation, and close-out visits
• Collaborate with cross-functional teams such as regulatory, pharmacovigilance, and legal, and support site selection and development efforts
• Act as SME for monitoring processes
• Contribute to audits/inspections
• Maintain accurate documentation in CTMS and eTMF systems
• Travel of 65-75% domestically and internationally, approximately 2-3 days per week

• Associate's or Bachelor’s degree in a healthcare/science discipline
• At least 5 years (Associate’s) or 2 years (Bachelor’s) of healthcare and site monitoring experience in biopharma or CRO
• Knowledge of GCP, clinical trial management, site performance, and monitoring tools
• Fluency in English and local languages
• High independence, excellent communication, organizational skills, and ability to manage complex issues across multiple protocols and therapy areas
• Position is remote with significant travel; candidates must reside in specified U.S. states