As the Research Associate, you assist with the collection, analysis and publication of clinical and economic data in our growing clinical research team. Reporting to the Clinical Study Lead, you will be responsible for participating in the design and execution of studies while providing expertise in the development of pre- and post-market study related strategy, design, implementation and documentation.
As a snapshot, we are looking for someone who:
- Has a strong background in clinical research methodology and is able to work both independently and collaboratively
- Has intermediate to advanced applied knowledge of the clinical research process, Good Clinical Practices, Compliance Requirements, FDA regulations governing clinical trials, and international standards for clinical studies
Job Duties and Responsibilities
- Define, communicate, and evaluate clinical & economic study objectives to deliver high quality data
- Lead the publication of study findings, including creation of manuscripts, white papers and clinical summary documents
- Coordinate the development of clinical study documents, including but not limited to: protocols, investigator brochures, informed consent documents, project plans, budgets, ethics review board submissions, etc.
- Participate in the analysis, summary, and reporting of clinical data for regulatory, marketing, or other purposes
- Maintain awareness of regulations and guidance documents concerning clinical evaluations ensuring organizational compliance
- Provide subject matter expertise to cross-functional product development teams
- Provide study specific training to members of the clinical study team
How is Success Measured or Challenges?:
- Success in this role will see the Research Associate leading a number of large and small-scale research projects to completion within established timelines and on budget
- Challenges will include the balancing multiple changing priorities and completion of high quality research in support of several departments and investigators
Required Skills and Experience
Skills and Experience to Enable Success:
- Master’s degree in a field such as Clinical Epidemiology or Health Research Methodology with up to 2 years of experience managing clinical research studies
- Excellent medical writing skills and experience
- Proficient in the clinical statistical analysis and the use of statistical software
- Must be capable of working with individuals internally and externally, ranging from investigators, facility managers and administrators to critical function areas, such as regulatory affairs, marketing, service and support, project management, R&D and manufacturing
- Working knowledge of the orthopaedic market and joint replacement surgery is an asset
- Experience with surgical guidance technologies is an asset
- Knowledge of the United States and Canadian health care systems, reimbursement and regulatory requirements in North America and worldwide is an asset
- Essential soft skills include:
- Exceptionally organized
- Strong attention to detail
- Ability to plan, prioritize, and lead
- Creative problem solver
The Journey, Mission and Future of Intellijoint Surgical
- What we are doing is “improving patients’ lives by providing every surgeon with effective, easy-to-use technology”
- Born out of a University of Waterloo final year design project, our product improves the accuracy of hip replacements
- In a nut shell, Intellijoint HIP® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during total hip arthroplasty
- Already, our product is being used in thousands of surgeries that spread throughout the United States, Canada and Australia and we will continue to look at expansion into other areas
What you can Expect and Experience at Intellijoint
- We do not expect to hire someone who fits the position 100%
- We expect that you will be passionate about growth and you can expect that we will support you along the way
- You can expect to work hard but know that you will be rewarded for that hard work
- You can expect change within our growing company
- You can expect that we help you be you!
- Flexibility so that you can do your best both at work and outside of it
- Relaxed yet professional workplace that encourages inclusivity
- An understanding of how your performance is measured
- Culture = Passion: We have a ton of passion for the product, improving patients’ lives and working collaboratively to achieve common goals
- Oh ya, some amazing social events too! These will be formal, informal, scheduled and pop up out of no where. Be prepared, we like to work hard but have some fun too!
If you aren’t happy about these expectations, we may not be the company for you. If you are happy with them, great! We would love to hear from you!
To apply, please visit our job board. This is a full time, permanent position based at Intellijoint Surgical’s main office in Kitchener, Ontario, Canada. Please submit cover letter and resume for consideration. Only selected applicants will be contacted for an interview. Thank you!