Clinical Research Associate (CRA) - Immunology-Remote

Scorpion Therapeutics; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics seeks a Clinical Site Manager to oversee performance and compliance of trial sites across the U.S. This role ensures ICH-GCP adherence, regulatory alignment, and company policy compliance through all trial phases.

The position requires strong site relationships, monitoring expertise, and collaboration with regulatory, pharmacovigilance, and legal teams. Significant travel (65-75%) is expected, with residency in specified U.S. states.

Qualifications

• Must have healthcare/science degree or equivalent.
• Strong communication and organizational skills required.
• Ability to manage complex issues across multiple protocols.

Responsibilities

• Develop strong site relationships.
• Manage site activities and regulatory documentation.
• Recruit participants and monitor trial progress.
• Oversee visits and trial monitoring (remote and onsite).
• Collaborate with regulatory, pharmacovigilance, and legal teams.
• Maintain CTMS/eTMF documentation and contribute to audits.

Skills

Communication

Organizational skills

Independent

Multi-protocol management

Education

Associate's or Bachelor's degree in healthcare/science

Tools

CTMS

eTMF

Job description

Role

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.

Responsibilities

• 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

Requirements

• 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