Senior CRA — Biotech Trials, Flexible Hours

Pulse Biosciences, Inc.; United States; On-site; USD 100,000 - 170,000; Full time

Benefits offered by this job

Stock options

Employee stock purchase plan (ESPP)

401k retirement savings

Job summary

Pulse Biosciences is seeking a Sr. Clinical Research Associate (Sr. CRA) to lead monitoring and coordination of soft tissue ablation clinical trials in the U.S. You will work with investigators, prepare study materials, and ensure data quality and regulatory compliance.

This role requires 5+ years in clinical research with at least 3 years in medical device or biotech CRA work, with travel up to 40%. Strong knowledge of CFR, FDA, GCP, and EDC/CTMS is preferred.

Qualifications

• BS/BA degree in a relevant scientific field.
• Minimum 5 years of clinical research or biotech experience.
• At least 3 years CRA experience in medical device or biotech trials.

Responsibilities

• On-site clinical monitoring across multiple studies with investigators and staff.
• Prepare informed consent forms, CRFs, study guides, and training materials.
• Review data listings and prepare interim/final reports.
• Ensure protocol adherence, subject safety, and data integrity.
• Develop monitoring tools and study-specific documents.
• Deliver high-quality monitoring reports within SOP timelines.
• Close action items from visits within planned timelines.
• Support regulatory submissions to IRB/IEC and authorities.
• Maintain knowledge of protocols and product development.

Skills

CRA experience

Regulatory knowledge

GCP knowledge

EDC systems

CTMS

FDA regulations

Communication skills

Travel readiness

Education

BS/BA degree in relevant science

CRA certification (CCRA/CCRP) preferred

Tools

Acrobat Adobe

Microsoft Word

Excel

PowerPoint

Smartsheet

Job description

Pulse Biosciences is seeking a Sr. Clinical Research Associate (Sr. CRA) to lead monitoring and coordination of soft tissue ablation clinical trials in the U.S. You will work with investigators, prepare study materials, and ensure data quality and regulatory compliance.

This role requires 5+ years in clinical research with at least 3 years in medical device or biotech CRA work, with travel up to 40%. Strong knowledge of CFR, FDA, GCP, and EDC/CTMS is preferred.