Remote Sr. CRA, Soft Tissue Ablation Trials

Pulse Biosciences; United States; Remoto; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Pulse Biosciences is seeking a Senior Clinical Research Associate to manage and monitor soft tissue ablation trials in the U.S. remote setup. The Sr. CRA will support study planning, site startup, patient recruitment, data quality, and regulatory compliance with CFR FDA and ICH-GCP.

You will provide on-site monitoring, develop study documents, coordinate data reports, review CRFs, and mentor junior CRAs while ensuring timelines and safety. Travel up to 40% may be required.

Competenze

• 5+ years of direct clinical research support experience.
• Minimum 3 years of CRA experience in medical devices or biotech.
• Cardiovascular/interventional/ablation device exposure preferred.
• CRA certification (CCRA/CCRP) preferred.
• Strong knowledge of FDA regulations and ICH-GCP.
• Willingness to travel up to 40%, with potential overnight/international trips.

Mansioni

• Provides on-site monitoring across multiple studies and coordinates with investigators and cross-functional teams.
• Prepares and maintains study documents including informed consent forms, CRFs, study guides, training materials, binders and patient diaries.
• Coordinates review of data listings and preparation of interim and final clinical study reports.
• Monitors CRFs (paper and/or EDC), source data, device accountability records, safety events and study records for protocol adherence and safety.
• Develops study-specific monitoring tools and related documents.
• Delivers high-quality monitoring reports and follow-up letters within SOP timelines.
• Reviews and approves essential regulatory documents across multiple studies.
• Assists the project team in developing study metrics and oversight.
• Oversees data queries and ensures timely closure to meet study goals.
• Supports regulatory submissions to IRB/IEC and authorities.
• Maintains knowledge of protocols, GCP, FDA regulations and device reporting.
• Coaches and mentors other CRAs in development and training.

Descrizione del lavoro

Pulse Biosciences is seeking a Senior Clinical Research Associate to manage and monitor soft tissue ablation trials in the U.S. remote setup. The Sr. CRA will support study planning, site startup, patient recruitment, data quality, and regulatory compliance with CFR FDA and ICH-GCP.

You will provide on-site monitoring, develop study documents, coordinate data reports, review CRFs, and mentor junior CRAs while ensuring timelines and safety. Travel up to 40% may be required.