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Clinical Research Strategist

4 months ago

Santa Barbara, United States Cognixion Full time
Job DescriptionJob DescriptionSalary:

About Us:

Cognixion is a pioneering company in the field of neurotechnology, dedicated to developing innovative solutions that enhance communication and interaction for individuals with neurological conditions. Our flagship product, Axon-R, is at the forefront of clinical research in neurology, ophthalmology, and disorders of consciousness. We are committed to advancing clinical research and improving patient outcomes through cutting-edge technology.


Job Summary:

We are seeking a highly organized and experienced Clinical Research Strategist to oversee clinical activities both internally and with external partners. This role will serve as the central hub of clinical knowledge within Cognixion, particularly focusing on emerging diagnostics and therapeutics that utilize augmented reality and neurology. In this position, you will advise internal technical and product teams on relevant clinical considerations for research and development projects. Additionally, you will collaborate with and guide external partners in planning and executing clinical studies. The ideal candidate will possess a deep understanding of clinical research best practices, especially in neurology, ophthalmology, and disorders of consciousness, and will have a proven track record of managing studies that achieved FDA clearance for medical devices and/or software-as-a-medical-device (SaMD).


Key Responsibilities:

  • Manage and oversee clinical partnerships with researchers utilizing the Axon-R product.
  • Act as the clinical subject matter expert for both the research and engineering teams.
  • Cultivate and sustain relationships with clinical partners.
  • Serve as the primary liaison for clinical partners, providing support and resolving issues during the research process.
  • Facilitate communication and collaboration between internal teams and external clinical partners.
  • Advocate for Cognixion solutions to ensure alignment between external research and Cognixion's strategic goals.
  • Support clinical partners in preparing publications, grant proposals, IRB submissions, and other related documents.
  • Regularly prepare and present updates and reports on the status of clinical programs to senior management.
  • Travel as needed to clinical sites within the US and Canada to support and supervise study activities.


Qualifications:

  • Bachelor’s degree in a relevant field; advanced degree preferred.
  • Appropriate certifications such as CCRP, GCP, CMDRP and HSP.
  • Minimum of 5 years of experience in clinical research, with a experience in neurology, ophthalmology, or disorders of consciousness.
  • Experience in pre-clearance research associated with novel medical devices.
  • Proven track record of managing clinical studies that have achieved FDA medical device clearance.
  • Excellent communication and interpersonal skills, with the ability to build and maintain strong relationships with clinical partners.
  • Ability to travel as needed within the US and Canada.
  • Knowledge of regulatory requirements and best practices in clinical research.


Preferred Qualifications:

  • Advanced degree in a related field (e.g., MS, PhD, MD).
  • Experience working in a startup or innovative tech environment.
  • Familiarity with neurotechnology and medical device development.


What We Offer:

  • Competitive salary and benefits package.
  • Opportunity to work with a dynamic and innovative team.
  • Chance to contribute to cutting-edge research and make a meaningful impact on patient outcomes.
  • Flexible remote work environment with travel opportunities.


How to Apply:

Interested candidates should submit their resume and a cover letter detailing their relevant experience and why they are a good fit for this role to [email address].


Cognixion is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.