Sr. Clinical Research Associate (Soft Tissue Ablation)

The role

The Sr. Clinical Research Associate manages and monitors activities for soft tissue ablation clinical trials. This role supports study planning, site start-up, patient recruitment, and data quality for U.S.-based and international studies.

What you will do

• Provides on-site clinical monitoring and procedural case support to research sites
• Prepares project and study-related documents including informed consent forms and study guides
• Coordinates review of data listings and preparation of clinical study reports
• Monitors clinical studies including CRFs, source documentation, and device accountability
• Develops study specific monitoring tools
• Delivers written monitoring reports and follow-up letters
• Ensures action items from monitoring visits are closed
• Reviews and approves essential regulatory documents
• Assists in developing study metrics
• Oversees clinical data to ensure queries are closed

Required qualifications

• BS/BA degree in relevant scientific discipline or equivalent experience
• 5+ years experience directly supporting clinical research or relevant experience in medical/scientific area
• At least 3 years of CRA experience in medical device or biotech clinical trials
• Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and Smartsheet
• Knowledge of FDA and international regulations and guidelines
• Proficient in using EDC and CTMS systems
• Working knowledge of FDA, European Regulatory and EC procedures
• Excellent oral, written communication skills with strong presentation skills
• Flexibility in work hours and readiness to travel up to 40% of the time, overnight and/or international travel may be required
• Ability to lift 10-15 pounds

Nice to have

• Cardiovascular, interventional, surgical, image-guided, or ablation device experience
• Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification

Benefits

• A variety of health insurance plans
• Supplemental insurance options
• 401k retirement savings plan
• Stock options awards
• Employee Stock Purchase Plan (ESPP)
• Paid time off
• Paid holidays
• Flexible work schedule
• Wellness program, including onsite gym and mindfulness classes

About the company

Pulse Biosciences is a bioelectric medicine company that uses CellFX nsPFA technology to deliver nanosecond pulses of electrical energy. The company designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients.