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Sr. Clinical Research Associate (Cardiac Catheter Products)

1 hour, 7 minutes ago
United States
Full-time
Senior
Operations Specialist
Operations
GCP
Apply Now
Pulse Biosciences

Pulse Biosciences

Powering the next generation in bioelectric medicine with Nanosecond Pulse Field Ablation technology. Pulse Biosciences pioneers in the research, design and production of our patented Nanosecond Pulsed Field Ablation™ (nsPFA™) technology for use in hig...

Health Care Providers & Services
51-250
Founded 2016
$80M raised
View All Jobs 5

Description

  • Manage and monitor clinical study activities across U.S. and international clinical sites.
  • Support research sites across multiple studies with minimal guidance.
  • Prepare study documents such as informed consent forms, CRFs, study guides, reference binders, and patient diaries.
  • Review data listings and coordinate preparation of interim and final clinical study reports.
  • Monitor paper and electronic case report forms and source documentation for protocol adherence and scientific validity.
  • Develop study-specific monitoring tools and related documents.
  • Write monitoring reports, confirmation letters, and follow-up letters within required timelines.
  • Track and close monitoring visit action items and clinical data queries within study timelines.
  • Review and approve essential regulatory documents across multiple studies.
  • Support IRB/IEC and regulatory submissions for clinical trials.
  • Coach and mentor other CRAs in training and development.
  • Oversee investigational product accountability, including storage, inventory, dispensing, return, and destruction records.
  • Manage protocol deviation documentation, tracking, and escalation.
  • Participate in site audits as requested.
  • Verify informed consent and protect the rights and well-being of study subjects.

Requirements

  • BS/BA degree or equivalent experience.
  • 5+ years of experience directly supporting clinical research or in a relevant medical/scientific area.
  • At least 3 years of CRA experience in device or biotech clinical trials.
  • Cardiovascular device experience preferred.
  • CRA certification such as CCRA or CCRP strongly preferred.
  • Proficiency with Adobe Acrobat, Microsoft Word, Excel, PowerPoint, and Smartsheet.
  • Experience with EDC and CTMS systems.
  • Knowledge of FDA and international regulations and guidelines, including GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance, and medical device reporting.
  • Working knowledge of FDA, European regulatory, and EC procedures as applicable.
  • Excellent oral and written communication skills, including presentation skills.
  • Strong critical thinking, analytical, problem-solving, and organizational skills.
  • Ability to work independently, manage multiple priorities, and adapt to changing requirements in a fast-paced environment.
  • Flexibility to travel 30% to 50% of the time, including overnight and international travel.
  • Ability to lift 10-15 pounds.

Benefits

  • A variety of health insurance plans and supplemental insurance options.
  • 401(k) retirement savings plan.
  • Stock options awards and Employee Stock Purchase Plan (ESPP).
  • Paid time off and paid holidays.
  • Flexible work schedule.
  • Wellness program, including an onsite gym and mindfulness classes.
  • Learning culture with professional and personal growth and development opportunities.
  • Commitment to a respectful, diverse, and inclusive work environment.

Interested in this position?

Apply directly on the company website

Apply Now

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