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Clinical Studies Coordinator (Onsite - Rochester, NY)

Casana

Casana

Boston, MA, USA · Rochester, NY, USA · Remote
Posted on Friday, January 12, 2024

Clinical Studies Coordinator (Onsite - Rochester, NY)

Do you have experience coordinating clinical research/studies and are looking for a new challenge in the healthcare industry that can have a positive health impact for millions of people? Do you love to face difficult problems head on, and thrive in a fast-paced environment? If so, we would love to speak with you about the Clinical Study Coordinator role at Casana.

The Clinical Study Coordinator supports clinical testing of a unique cardiovascular monitoring system, and future IoT medical products by seamlessly integrating into clinician workflows, and meeting FDA regulatory requirements. This role helps define, execute, and document device testing with human subjects, and will provide support to other Casana initiatives as needed. The Clinical Study Coordinator provides strong technical skills, exceptional attention to detail, passion for technology innovation, and determination to meet the needs of the Clinical Affairs department. The successful candidate will be a clear communicator, able to work independently, thrive in a startup environment, and be open to taking on new responsibilities. This position is based in Rochester, NY.

What You’ll Do:

  • Support and facilitate the efficient administration of clinical studies, internally and externally
  • Collaborate with Principal Investigators (PIs) and Clinical Studies Manager, including support of protocol development, IRB submissions, subject recruitment, data collection, monitoring of data collection and processing, and ensuring adherence to study protocols
  • Create, review, modify, and maintain subject data generated from pilots and clinical studies
  • Ensure all supplies and equipment for studies are available and working correctly
  • Assist with the management of clinical study tools, including electronic data capture and other tools
  • Interface with external partners that are running clinical studies for Casana
  • Maintain study records per FDA and GCP guidelines
  • Propose and contribute to new processes, procedures, and tools that can improve the Casana’s ability to run effective, compliant, and efficient clinical studies
  • Other responsibilities as needed

What You’ll Bring:

  • 2+ years in a healthcare related research or study coordinator role
  • Analytical mindset
  • Strong written and verbal communication skills with the ability to effectively interface with individuals across a broad spectrum of expertise
  • Strong interpersonal skills with the confidence to be a brand ambassador for Casana with external stakeholders
  • Exceptional attention to detail in calculations, hands-on experimentation, and documentation
  • Active learner with the ability to rapidly become proficient with a broad range of hardware and software technologies
  • Ability to work in an environment that requires self-education and self-direction
  • Demonstrated project management skills

Experience that is a plus

  • Associates degree in Nursing or related field
  • 5+ years in a research or study coordinator role
  • Experience with medical devices
  • Experience with human subjects testing

About Casana

Casana is innovating healthcare delivery with a smart toilet seat that enables effortless, integrated, and consistent in-home health monitoring. The Heart Seat® captures key clinical values, including FDA cleared heart rate, blood oxygenation, and future clinical measurements in development such as blood pressure.

The healthcare system has been searching for this actionable intelligence for decades, and it turns out, we were sitting on a great idea all along.

Compensation

[$55,000 to $65,000] Exact compensation may vary based on skills, experience and location. Our compensation consists of base salary and equity as well as a generous benefits package.

Casana provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.