Senior Clinical Research Associate, Soft Tissue Ablation

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 activities supporting successful execution of soft tissue ablation clinical trials • Support study planning and site start-up activities • Monitor patient recruitment, data quality, protocol adherence, subject safety, and study-related site activities • Provide on-site clinical monitoring and procedural case support across multiple studies • Coordinate with investigators, research staff, and cross-functional internal stakeholders • Prepare project and study documents, including informed consent forms, CRFs, study guides, training materials, study binders, and patient diaries • Coordinate data listing reviews and preparation of interim and final clinical study reports • Review CRFs, source documentation, procedural data, device accountability records, safety events, and other study records • Develop study-specific monitoring tools and related documents • Deliver monitoring reports, confirmation letters, and follow-up letters within required timelines • Close action items from monitoring visits within monitoring-plan timelines • Review and approve essential regulatory documents across multiple studies • Assist with study metrics and clinical trial execution • Oversee clinical data and query closure • Support trial submissions to IRB/IEC and regulatory authorities • Ensure study timelines are maintained across multiple studies • Coach and mentor other Clinical Research Associates • Maintain working knowledge of protocols and product development • Coordinate, organize, communicate, and manage site activities; escalate issues when appropriate • Verify subject rights, well-being, and informed consent • Perform device accountability, including storage, inventory, return/destruction, and disposition/receipt records • 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 in a relevant scientific discipline or equivalent experience • 5+ years’ experience directly supporting clinical research or relevant medical/scientific experience • At least 3 years of CRA experience in medical device or biotech clinical trials • Cardiovascular, interventional, surgical, image-guided, or ablation device experience preferred • CRA certification such as CCRA or CCRP strongly preferred • Proficiency in Adobe Acrobat, Microsoft Word, Excel, PowerPoint, and Smartsheet • Ability to quickly become proficient in other computer software programs • Knowledge of FDA and international regulations and guidelines, including GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance, and medical device reporting • Proficiency using EDC and CTMS systems • Working knowledge of FDA, European Regulatory, and EC procedures, as applicable • Excellent oral and written communication and presentation skills • Clear and systematic thinking, good judgment, and problem-solving competencies • Excellent critical-thinking and analytical skills • Strong organizational skills; ability to work with minimal direction, take initiative, manage projects, and recommend actions • Ability to work as a team member, multitask, and adapt flexibly to changing priorities • Flexibility in work hours and readiness to travel up to 40% of the time, including possible overnight and international travel • 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 • Learning culture • Respectful, diverse work environment