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Clinical Research Associate

Epineuron is a clinical-stage medical device company on a singular mission to maximize human potential. We are focused on the development and commercialization of first-in-class therapeutic devices to aid in the surgical repair and treatment of peripheral nerves. Our lead product is a novel wearable that accelerates regeneration of injured nerves - it is designated an FDA Breakthrough
Device and is Health Canada approved. We are growing a dynamic team to support ongoing and new clinical translation initiatives and are looking for talented individuals, like yourself, to join Epineuron. Are you ready?

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Appointment
Contract Full-time (1.5 years), possibility for permanent full-time

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Job Description

​We are looking for a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our growing Clinical Operations team. The CRA will play a critical role in the successful execution and oversight of our clinical trials, ensuring adherence to protocols, Good Clinical Practice (GCP), and all applicable regulatory requirements. This role requires a strong understanding of clinical trial
processes, exceptional communication skills, and a passion for advancing innovative medical technologies that impact patient lives. You will report directly to the Clinical Research Manager, support the Clinical Applications Specialists, and act as site monitor and liaison to the clinical trial sites across Canada and the USA. The CRA is responsible for coordinating study activities, ensuring compliance of the clinical trials, preparing/maintaining study documents, and engaging with the clinical trial sites. The ideal candidate is an excellent team player, detail-oriented and organized, and ready to take on any challenge.

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Responsibilities

  • Conduct comprehensive site qualification, initiation, interim monitoring, and close-out visits in accordance with study protocols, Good Clinical Practice, and SOPs.

  • Ensure the integrity of clinical data through source document verification, review of case report forms (CRFs), and resolution of data queries.

  • Assess site performance, identify potential risks, and implement corrective and preventative actions as needed.

  • Support and manage ethics board and regulatory submissions.

  • Support audit and inspection readiness activities.

  • Prepare site study training materials and conduct site training sessions.

  • Organize and maintain clinical trial master files and investigational site files.

  • Manage communication and correspondence with clinical trial sites and internal/external stakeholders.

  • Manage and maintain study databases.

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Qualifications

Required

  • Bachelor’s degree in a life science and/or health-related discipline.

  • Highly organized with meticulous attention to detail.

  • Strong oral and written communication skills.

  • Highly responsive to all communications.

  • Excellent interpersonal skills and a demonstrated ability to effectively engage with a diverse set of external stakeholders.

  • Strong project management and time management skills.

  • Critical thinker and problem solver, with the drive to work in a fast-paced environment.

  • Proficient in MS Office (e.g., Word, Excel, PowerPoint, etc.).

  • Valid driver’s license in good standing and passport with the ability to travel for business purposes.

Preferred

  • 1-2 years of clinical trial coordination and management experience.

  • Certificate and/or diploma in clinical research coordination.

  • Graduate degree in life or health sciences (e.g., MSc or PhD).

  • Direct involvement in preparation and submission of regulatory and/or ethics board applications.

  • Direct experience with execution of clinical trials and engagement with various clinical site stakeholders (e.g., principal investigators, research coordinators, etc.).

  • Experience in medical device studies in surgical specialties including plastics, orthopedics, and neurosurgery.

  • In-depth knowledge of ISO 14155, Good Clinical Practice, and medical device regulatory requirements.

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Why you’ll love working at Epineuron: 

  • Be part of a groundbreaking company developing innovative solutions to address significant unmet medical needs in nerve recovery.

  • Opportunity to work on an FDA Breakthrough Device designated technology.

  • We have a friendly, open, and fun team culture that values unique perspectives.

  • We enjoy discovering great foods locally and drink great coffee, fresh ground and brewed.

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Compensation commensurate with experience
Added perks we offer:

  • A full benefit package including medical and dental for full-time employees.

  • An open, collaborative and inclusive work environment.

  • Our head office includes a modern gym, volleyball court, basketball court, a calisthenics park.

  • On-site parking and EV charging stations

  • Excellent coffee, seriously.

 

Anticipated Start Date: July 2025

Schedule: Full time (Monday to Friday at 8 hours per day or 40 hours per week). Travel 20-30% of time within Canada and US.

Please submit your resume/CV and cover letter as a PDF to jobs@epineurontech.com with the subject line “Job App CRA 2025-01”.

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Epineuron is an equal opportunity employer. We are committed to providing a diverse and inclusive work environment, while providing ongoing education for all employees. Qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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Please inform us if you require any accommodations during the recruitment process. While we thank all applicants, only those being considered for an interview will be contacted.

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