Sr. Clinical Research Associate (Soft Tissue Ablation)

Pulse Biosciences, Inc.; United States; Sur place; USD 100 000 - 170 000; Plein temps

Avantages offerts par ce poste

Stock options

Employee stock purchase plan (ESPP)

401k retirement savings

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

CRA experience

Regulatory knowledge

GCP knowledge

EDC systems

CTMS

FDA regulations

Communication skills

Travel readiness

Formation

BS/BA degree in relevant science

CRA certification (CCRA/CCRP) preferred

Outils

Acrobat Adobe

Microsoft Word

Excel

PowerPoint

Smartsheet

Description du poste

Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine

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.

Why Join Us?

At Pulse Biosciences, we are driven by purpose and innovation.

• Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.
• Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.
• Our Commitment: Hiring the best and brightest minds to advance our world-class organization.

What You Will Experience

• 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.

About The Role

The Sr. Clinical Research Associate (Sr. CRA) is responsible for managing and monitoring activities that will lead to the successful execution of soft tissue ablation clinical trials. This position supports study planning and site start-up activities, and monitors patient recruitment, data quality, and study-related activities associated with clinical site participation. The Sr. CRA supports primarily U.S.-based clinical studies, including feasibility, post-market, and non-IDE research, with opportunities to contribute to future international and pivotal clinical trials. Ensures that duties are performed in accordance with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP).

To Make An Impact, You Will

• Provides on-site clinical monitoring and procedural case support to research sites across multiple studies, including coordination with investigators, research staff, and cross-functional internal stakeholders with minimal guidance.
• Prepares and develops project and study-related documents including informed consent forms, CRFs, study guides, site training materials, study binders, and patient diaries, as applicable.
• Coordinates review of data listings and preparation of interim and final clinical study reports.
• Responsible for monitoring clinical studies, including review of case report forms (CRFs) both paper and/or electronic data capture (EDC), source documentation, procedural data, device accountability records, safety events, and other study records to ensure protocol adherence, subject safety, and scientific validity of the data.
• Responsible for developing study specific monitoring tools and other related documents.
• Delivers high quality written monitoring reports, confirmation and follow-up letters within the timelines of SOPs and monitoring plans.
• Ensures that all action items from monitoring visits are closed within the timelines of monitoring plans.
• Responsible for reviewing and approving essential regulatory documents across multiple studies.
• Assists the project team in developing study metrics to ensure the efficient execution of a clinical trial.
• Oversees clinical data to ensure queries are closed within stipulated timelines of study goals.
• Provides clinical support for submission of trials to IRB/IEC and regulatory authorities.
• Ensures adherence to study timeline across multiple studies.
• Coaches and mentors other Clinical Research Associates (CRAs) in development and training.
• Maintains strong working knowledge of protocols and product development across multiple studies.
• Demonstrates ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to elevate issues to management or clinical team.
• Demonstrates an excellent working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigations.
• Verifies the rights and well-being of study subjects are protected and verifies that written informed consent was obtained before each subject’s participation in the study.
• Performs device accountability, including storage, inventory, return/destruction, and disposition/receipt records.
• Ensures compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agencies.
• Manages Protocol Deviation documentation, tracking, and escalation.
• Participates in site audits, as requested.

To Excel, You Will Bring

• BS/BA degree in relevant scientific discipline or equivalent experience.
• 5+ years’ experience directly supporting clinical research or relevant experience in medical/scientific area.
• Must have at least 3 years of CRA experience in medical device or biotech clinical trials.
• Cardiovascular, interventional, surgical, image-guided, or ablation device experience preferred.
• Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred.
• Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and Smartsheet; and the ability to quickly become proficient in a variety of other computer software programs.
• Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting.
• Proficient in using EDC and CTMS systems.
• Working knowledge of FDA, European Regulatory and EC procedures, as applicable.
• Excellent oral, written communication skills with strong presentation skills.
• Clear and systematic thinking that demonstrates good judgement and problem-solving competencies.
• Excellent critical thinking analytical skills.
• Strong organizational skills with the ability to work conscientiously and with minimal direction, using good judgement, 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.
• 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.

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.