Clinical Trial Support Specialist, International

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.  The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.

The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more.

• →Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!
• →Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!
• →Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!
• →Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.
• →Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
• →Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.
• →Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce. 

The Clinical Trials Support Specialist is an essential member of the Clinical Affairs Department. This role assists with the overall conduct of clinical studies consistent with applicable regulations, guidelines, and policies in accordance with international Regulatory and Ethical guidelines for Good Clinical Practice (GCP) and International Conference on Harmonization (ICH). This position requires residence within the European Union EU.

• Responsible for collecting study device and procedural data according to study protocols and regulatory guidelines at a regional/country level.
• Manage relationships with study sites, principal investigators (PIs), contract research organizations (CROs), and other study related vendors.
• Participate in pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan and applicable SOPs, to assure compliance with the protocol, country, regional and local hospital ethics committee requirements and 14155:2020.
• Ensure investigators are performing study procedures as outlined in the product’s Instructions for Use and Investigator Brochure Help with documenting adverse events and/or device deficiencies that are observed during a case in accordance with study protocols, country-specific regulatory requirements and the Monitoring Plan.
• Provides feedback as necessary to investigators both within operating room setting and outside operating room setting on the directions for use specific to the product and its maintenance.
• Takes a positive, proactive approach to solving non-complex and/or unusual clinical/therapy/technical problems Confirm subject eligibility per protocol prior to attending a case at investigator sites.
• Support device logistics, including shipments, returns, and reconciliation.
• Manage clinical supply inventory and ordering.
• Track and prepare study-specific information utilizing databases, spreadsheets, and other tools, such as Smartsheets.
• Assists with development and assembly of study binders and associated documents.
• Attend and participate in team teleconferences/meetings.

• Bachelor’s degree (BS/BA) or equivalent experience required.
• 3+ years of direct experience supporting multi-site clinical trials or equivalent experience in medical/scientific area.
• Expertise in cardiology or medical device trials is preferred.
• The ability to work in a lab/operating room environment.
• Functional knowledge of human anatomy and physiology, basic knowledge of surgery
• Knowledge of international regulations and guidelines including clinical strategy, GCPs, SOPs, submissions, product launch, labeling, product vigilance and medical device reporting.
• Strong customer orientation and site engagement skills.
• Proficient in Acrobat Adobe, Smartsheet, Microsoft Office Suite applications; and capable of learning other computer software programs including electronic data capture (EDC) and Trial Master File.
• Proficiency in English is essential, and fluency in other languages relevant to the study sites is highly desirable. 
• Strong organizational, written, verbal communication and presentation skills.
• Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
• Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.
• Ability to travel on an average of 60-85%, depending on project needs.
• Ability to lift 10-15 pounds.

Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.  To learn more about us, visit our website at www.pulsebiosciences.com.

We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.