Clinical Research Associate

**Job Overview**
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. The CRA 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.

**Summary of 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.

**Job 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 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.

**Anticipated Start Date**July 2025

Compensation commensurate with experience

**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.

**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 with EV charging stations
- Excellent coffee, seriously.

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

**Location**:1875 Buckhorn Gate, Mississauga, ON, L4W 5P1

Epineuron complies with the Ontario Human Rights Code and believes that every person has the right to equal treatment with respect to employment without discrimination or harassment because of race, ancestry, place of origin, colour, ethnic origin, citizenship, creed, sex, sexual orientation, gender identity, gender expression, age, record of offences, marital status, family status or disability.

**Job Type**: Fixed term contract
Contract length: 18 months

Additional pay:

- Retention bonus

**Benefits**:

- Casual dress
- Company events
- Dental care
- Extended health care
- Life insurance
- Mileage reimbursement
- On-site gym
- On-site parking
- Paid time off
- Vision care

Flexible language requirement:

- French not required

Schedule:

- Monday to Friday

Application question(s):

- Are you legally authorized to work in Canada?

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