Clinical Research Associate: Site Oversight & Data Integrity

Lycia Therapeutics, Inc.; South San Francisco (CA); Presencial; USD 125.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Equity

Generous benefits package

Descripción de la vacante

Lycia Therapeutics, Inc. is a Nasdaq-listed clinical-stage biotech in South San Francisco seeking a Clinical Research Associate to monitor trial sites for ethical conduct and safety under GCP and regulatory guidelines.

You will serve as the primary link between Lycia and investigative sites. Responsibilities include site management, regulatory tracking, data query handling, and remote monitoring support, with up to 30% travel.

Formación

• Education: Bachelor’s or advanced degree in a life science, nursing, pharmacy, or health-related field.
• Experience: 2+ years of clinical research experience (e.g., CRC, data assistant, or junior CRA).
• Regulatory Knowledge: ICH-GCP, FDA regulations, EU and local ethics/IRB processes.
• Technical Skills: Proficiency with EDC systems and CTMS.
• Core Competencies: Detail-oriented, strong communication, organized.
• Travel: Up to 30% travel.

Responsabilidades

• Site Management & Support: assist with investigator recruitment, site selection, startup and close-out.
• Regulatory Tracking: maintain essential documents and ISFs for audits.
• Data Management: review data points and write data queries in EDC.
• Remote Monitoring: support traveling CRAs and track KPIs.
• Compliance: ensure GCP/ICH/FDA/ SOP adherence and escalate issues.

Conocimientos

Attention to detail

Communication skills

Time management

Travel readiness

Educación

Life science degree

Herramientas

EDC systems

CTMS

Descripción del empleo

Lycia Therapeutics, Inc. is a Nasdaq-listed clinical-stage biotech in South San Francisco seeking a Clinical Research Associate to monitor trial sites for ethical conduct and safety under GCP and regulatory guidelines.

You will serve as the primary link between Lycia and investigative sites. Responsibilities include site management, regulatory tracking, data query handling, and remote monitoring support, with up to 30% travel.