Sr. Clinical Research Associate

About the role

The Sr. Clinical Research Associate operates with significant ownership over the end-to-end execution of U.S.-based clinical trials, ensuring adherence to protocol and regulatory standards from feasibility through closeout. You will manage the full site initiation and monitoring lifecycle, proactively mitigating risks to enrollment and data integrity for soft tissue ablation studies. This role owns the oversight of patient recruitment, site performance, and the quality of case report forms to ensure timely and accurate data capture. You will serve as the primary liaison between clinical sites and internal cross-functional teams, coordinating complex study activities with minimal direct supervision. The position requires active interpretation and application of evolving FDA and ICH-GCP regulations to all assigned study operations. You will identify and resolve study deviations, ensuring prompt and accurate resolution while maintaining comprehensive documentation. This role contributes strategically to study planning and site selection for current and future international and pivotal trials. You will support the collection and validation of procedural data to demonstrate the safety and effectiveness of CellFX nsPFA technology.

Key facts

What you'll do

Coordinate with investigators and research staff to ensure protocol compliance and alignment with study objectives across assigned clinical trials.

Perform on-site monitoring visits to assess study execution, verify data source documentation, and confirm accurate procedural reporting.

Develop and maintain project-specific documentation, including study protocols, monitoring plans, and informed consent templates.

Screen and qualify clinical sites based on feasibility, procedural volume, and investigator expertise for soft tissue ablation studies.

Manage subject enrollment and retention activities, tracking timelines and resolving recruitment barriers at the site level.

Oversee the collection, entry, and validation of clinical data in electronic data capture systems to ensure completeness and accuracy.

Conduct risk-based monitoring to identify and escalate potential safety issues, adverse events, and protocol deviations for timely resolution.

Coordinate with biostatistics and data management teams to ensure database lock processes are executed according to study timelines.

Support the preparation of regulatory submissions and investigator reporting documents for FDA and international authority requirements.

Provide procedural case support and training to clinical site staff to ensure consistent application of study-specific workflows.

Manage site payments and study supply logistics, ensuring alignment with sponsor budgets and study protocols.

Collaborate with cross-functional internal stakeholders to resolve operational issues and unanticipated study challenges.

Represent Pulse Biosciences at clinical site visits, conveying study expectations and reinforcing quality standards to research teams.

Ensure timely closeout of study activities, including final site visits, financial reconciliation, and study documentation archiving.

Requirements

Bachelor's degree in life sciences, nursing, or related healthcare field required; Master's degree preferred.

Minimum of five years of progressive clinical research experience, with at least two years in a supervisory role.

Prior clinical research experience in ablation procedures, electrophysiology, or surgical technology strongly preferred.

Demonstrated experience conducting U.S.-based clinical trials, including feasibility, conduct, and closeout activities.

Proficiency with electronic data capture systems and clinical trial management systems is mandatory.

Comprehensive understanding of FDA 21 CFR Part 11 and ICH-GCP guidelines governing clinical research operations.

Strong written and verbal communication skills required to interact with investigators, site staff, and internal leadership.

Ability to travel domestically for site monitoring visits, including overnight stays, with variable and extended travel schedules.

Must be eligible to obtain a U.S. passport or permanent residency if not currently held.

Relocation to or remote work within the United States is required for this role.

Nice to have

Previous experience with neuromodulation or bioelectronic medicine platforms.

Familiarity with CellFX nsPFA technology or prior experience in pulsed field ablation.

Experience managing multi-site, international clinical trials.

Practical notes

This role requires domestic travel for on-site monitoring activities, including overnight stays.

Candidates must be eligible to work in the United States without sponsorship for this position.

Relocation or remote work within the United States is required.