Senior Clinical Research Associate — Hybrid, Global Trials Lead

Medicines360; San Francisco (CA); Hybride; USD 110 000 - 150 000; Plein temps

Résumé du poste

Medicines360 in San Francisco is seeking a Senior Clinical Research Associate to manage day-to-day operational execution, site monitoring, and cross-functional collaboration across domestic and international trials. This role requires adherence to study protocols, regulatory standards, and quality data practices.

The Sr. CRA will work with CROs, vendors, and investigators, mentor junior staff, and contribute to inspection-ready documentation and program-level risk management in a hybrid work

Qualifications

• 5+ years of clinical research experience including independent site monitoring.
• Experience in women’s health is highly desirable.
• Experience with CROs and multicenter studies is preferred.
• FDA/ICH knowledge and Good Clinical Practice (GCP) compliance required.

Responsabilités

• Lead day-to-day clinical operations across the study lifecycle, including site feasibility, start-up, conduct, monitoring, closeout, and archival for trials of varying size.
• Serve as the primary contact for investigators and site staff; build strong site relationships and drive site activation, enrollment, and retention.
• Coordinate site clinical trial agreements, budgets, and payments; track terms and ensure fiscal accountability.
• Draft, review, and maintain trial documents, monitoring plans, and study-related communications to support regulatory submissions.

Connaissances

Clinical monitoring

Communication skills

Documentation & data integrity

Project management

Travel up to 50%

Formation

Bachelor’s degree in life sciences

Advanced degree preferred

Outils

Microsoft Office Suite

Description du poste

Medicines360 in San Francisco is seeking a Senior Clinical Research Associate to manage day-to-day operational execution, site monitoring, and cross-functional collaboration across domestic and international trials. This role requires adherence to study protocols, regulatory standards, and quality data practices.

The Sr. CRA will work with CROs, vendors, and investigators, mentor junior staff, and contribute to inspection-ready documentation and program-level risk management in a hybrid work