[Hiring] Sr. Clinical Research Associate @Pulse Biosciences

Role Description

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).

• Provides on-site clinical monitoring and procedural case support to research sites across multiple studies.
• 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), source documentation, procedural data, device accountability records, safety events, and other study records.
• 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.
• Demonstrates an excellent working knowledge of clinical research processes, Good Clinical Practices, and applicable regulations.
• 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.

Qualifications

• 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.
• Knowledge of FDA and international regulations and guidelines.
• 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.
• Ability to work as a team member, multi-task and be very flexible.
• Flexibility in work hours and readiness to travel up to 40% of the time.
• Ability to lift 10-15 pounds.

Benefits

• A variety of health insurance plans and supplemental insurance options.
• 401k retirement savings plan.
• Stock options awards and Employee Stock Purchase Plan (ESPP).
• Paid time off, paid holidays, flexible work schedule.
• Wellness program, including onsite gym and mindfulness classes.
• Commitment to providing a respectful work environment to our diverse workforce.