Job Description

The internal Clinical Research Scientist is a supporting role for the Clinical Affairs team, with key responsibilities focused on research activities to support study design. This role will also include responsibilities for study operations such as development of clinical study tools/documents, site management activities, and field-based operational activities. This role will work cross-functionally and collaborate closely with Regulatory, Quality, Product Development, Neuroscience, plus Data Science and Engineering teams.

This position is instrumental in supporting the company's continued growth and future success, and requires an individual with a "can-do," self-starter attitude who is excited about working collaboratively and diving into hands-on, detailed clinical work in an early-stage medical device company. This position is based on-site in Austin, Texas and will have less than 25% travel.

Key Responsibilities

• Authoring, leading, and/or supporting the development of clinical study documents, including but not limited to - clinical trial protocols, protocol amendments, patient informed consent forms, case report forms, clinical study reports, registrations, project, IRB submissions, recruitment materials, and training/educational materials. This responsibility will require individual effort to create deliverables coupled with extensive teamwork with internal staff and external parties (investigators and study site staff).
• Synthesize literature, competitive information, and results from neuromodulation and BCI implantable studies to inform Paradromics clinical research projects. This responsibility will require the ability to efficiently learn and communicate the findings from such research projects
• Analyzing data and drafting or supporting manuscripts and other presentation style content
• Support clinical operations activities including IRB/ethics submissions, data collection, discrepancy resolutions, monitoring activities, data analysis/reporting plans, safety oversight workflows, and other required elements of clinical studies under IDE (such as annual reporting)
• This role may function as a sponsor representative, overseeing study sites and clinical study activities to ensure adherence to applicable protocols and country specific requirements
• Use scientific and medical knowledge to develop and provide strategic communication to internal staff/management as well as study sites.
• Maintain all study documents and communications necessary for trial execution
• Maintain compliance to all SOP, GCP, and regulatory processes
• Excellent technical knowledge of Paradromics products, technologies, and procedures
• Excellent clinical process acumen and ability to drive clinical functional excellence activities
• Drive high quality data collection to support scientific communications, clinical research, and statistical evidence dissemination strategies
• Works collaboratively with Regulatory Affairs, Quality, Neuroscience, Project Management, external CROs or Medical Writers, Training, Marketing, Senior Management and investigational sites
• Collaboration and direct development activities with Data Science and Engineering to realize clinical study designs
• Other duties as assigned.
  
  

Qualifications

• Bachelor’s degree in an Engineering, Science, or related technical or clinical research field
• Minimum 3 years of clinical research experience (combined) working on behalf of study sponsors, study sites, and/or other clinical research organizations.
• Experience in neurostimulation, neuromodulation, deep brain stimulation, brain computer interface, and other active implantable devices or neural implants is highly desired
• Experience with Good Clinical Practice (GCP)
• Ability to work independently
• The desire to thrive in a team environment with a diverse group of people, where individual contributions are highly valued.
• Detail oriented with ability to deliver high quality output consistently and on time
• The desire for continuous learning and improvement
• Ability to thrive in times of change while adhering to cultural focus on people and patients.
• Critical thinker with excellent communication skills both orally and in written form with a desire for in-person communication.
• Excellent organizational skills and the ability to manage competing priorities and plan accordingly
  
  

Preferred Qualifications

• Advanced degree(s) in Engineering, Science, or another related field
• Experience working directly in the brain-computer interface space or deep brain stimulation
• Experience designing and executing clinical studies to collect and analyze neural data in response to human behavior.
• Experience with active electronic medical devices containing software
• Certification(s) in a clinical affairs or clinical research discipline
  
  

Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

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