Clinical Research Associate (Fully Remote)

Lycia Therapeutics; United States; À distance; USD 70 000 - 110 000; Plein temps

Avantages offerts par ce poste

Health insurance

Résumé du poste

Lycia Therapeutics, a clinical-stage biotechnology company based in South San Francisco, seeks a Clinical Research Associate to support investigator sites across the trial lifecycle. You will assist with site selection, startup activities, and ongoing site communications to ensure study progress.

In this role, you will track regulatory documents, maintain ISF/eTMF, and resolve data queries while ensuring GCP and FDA compliance. You may travel up to 30% and conduct visits in person or remotely.

Qualifications

• Requires a life science degree and 2+ years of clinical research experience.
• Willingness to travel up to 30%.
• Experience with site management is a plus.

Responsabilités

• Assist with investigator recruitment, site selection, startup, and close-out tasks.
• Provide ongoing operational support to sites via phone and email.
• Track essential regulatory documents and ISF for audit readiness.
• Maintain eTMF and resolve EDC data queries.
• Conduct qualification, initiation, interim, and close-out visits in person or remotely.
• Verify source data, ensure GCP/FDA compliance, and elevate protocol deviations.

Connaissances

Clinical research

GCP compliance

Site monitoring

Formation

Life science degree

Description du poste

• Assist with investigator recruitment, site selection, startup, and close-out tasks.
• Provide ongoing operational support to sites via phone and email.

Regulatory and Data:

• Track essential regulatory documents and ISF for audit readiness.
• Maintain eTMF and resolve EDC data queries.

Monitoring and Compliance:

• Conduct qualification, initiation, interim, and close-out visits in person or remotely.
• Verify source data, ensure GCP/FDA compliance, and elevate protocol deviations.

Qualifications:

• Requires a life science degree and 2+ years of clinical research experience.
• Willingness to travel up to 30%.

Lycia Therapeutics

Lycia Therapeutics is a clinical-stage biotechnology company developing LYTAC-based therapeutics to degrade disease-driving proteins. It went public in 2026 and is headquartered in South San Francisco, California.