Senior Clinical Research Associate, Cardiac Catheter Products

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Pulse Biosciences, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2016

💼 Consulting

🏭 Manufacturing

🏥 Healthcare

Consulting • Manufacturing • Healthcare

Pulse Biosciences, Inc. is a pioneering company in bioelectric medicine, specializing in the development of its proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology for healthcare applications. The company focuses primarily on innovative treatments in cardiology, particularly for conditions such as atrial fibrillation, utilizing their CellFX platform to improve patient outcomes. Through rigorous research and development, Pulse Biosciences aims to enhance cardiac care, offering groundbreaking solutions that promise safer and more effective treatment options across various therapeutic areas.

📋 Description

• Manage and monitor clinical study activities at US and international clinical sites • Monitor patient recruitment, clinical data, and study-related information • Provide case support to research sites across multiple studies with minimal guidance • Prepare project and study documents, including informed consent forms, CRFs, study guides, reference binders, and patient diaries • Coordinate data listing reviews and interim and final clinical study reports • Review CRFs and source documentation to ensure protocol adherence and data validity • Develop study-specific monitoring tools and related documents • Deliver monitoring reports, confirmation letters, and follow-up letters within required timelines • Close missing action items from monitoring visits • Review and approve essential regulatory documents • Support study metrics and efficient clinical trial execution • Oversee clinical data and ensure queries are closed on time • Support submissions to IRB/IEC and regulatory authorities • Ensure study timelines are met across multiple studies • Coach and mentor other Clinical Research Associates • Maintain knowledge of protocols and product development • Coordinate and manage site activities and escalate issues when appropriate • Ensure protection of study subjects’ rights and well-being and verify informed consent • Perform investigational product accountability • Ensure adverse event and serious adverse event reporting compliance • Manage protocol deviation documentation, tracking, and escalation • Participate in site audits as requested

🎯 Requirements

• BS/BA degree 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 device or biotech clinical trials • Cardiovascular device experience preferred • CRA certification such as CCRA or CCRP strongly preferred • Proficiency in Adobe Acrobat, Microsoft Word, Excel, PowerPoint, Smartsheet, EDC systems, and CTMS systems • Knowledge of FDA and international regulations and guidelines, including GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance, and medical device reporting • Working knowledge of FDA, European Regulatory, and EC procedures, as applicable • Excellent oral and written communication skills with strong presentation skills • Critical thinking, analytical, organizational, problem-solving, and judgment competencies • Ability to work as a team member, multitask, and adapt to changing priorities • Flexibility in work hours and readiness to travel 30%-50% of the time; overnight and/or international travel may be required • Ability to lift 10-15 pounds

🏖️ Benefits

• A variety of health insurance plans and 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 • Professional and personal growth and development opportunities