Note: The job is a remote job and is open to candidates in USA. Pulse Biosciences is a bioelectric medicine company developing CellFX nanosecond Pulsed Field Ablation technology for healthcare applications. The Sr. Clinical Research Associate manages and monitors U.S.-based soft tissue ablation clinical trials, supporting study planning, site start-up, patient recruitment, data quality, regulatory compliance, and clinical site activities. The role also provides procedural support, mentors CRAs, and contributes to clinical reports and regulatory submissions.
Responsibilities
- 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 escalate 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
Skills
- 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
- 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
- Cardiovascular, interventional, surgical, image-guided, or ablation device experience preferred
- Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred
Benefits
- Learning culture focusing on professional and personal growth and development
- 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
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