Job Responsibilities : Clinical Research Associate
Salary : 18 per hour
Company : Cloud DX
Location : Remote CA
About Cloud DX
Cloud DX is an industry leader in digital health care virtual care remote patient monitoring hardware and software. The company’s award-winning solutions enable chronically ill patients to stay at home and out of the hospital drastically improving health outcomes while at the same time significantly reducing costs to treat the most expensive patients in the healthcare system. Cloud DX is relentlessly committed to serving patients driving Innovation delivering results and making a difference in communities across North America and globally. The Company was founded in 2014 and has grown into a leader in the Virtual Care Market in North America. The current COVID crisis has accelerated the adoption of virtual care in our markets and Cloud DX is investing in expanding our US Sales and Marketing efforts.
Cloud DX is growing and we are looking for a Clinical Research Associate (CRA) who will plan support and manage clinical studies for our products. The role will also support the planning and development of Cloud DX’s clinical program to help us build the future of digital health care.
As our Clinical Research Associate you will have significant strategic and cross-functional influence and contribute directly to our mission to make healthcare better for everyone! The successful candidate will work remotely and travel to sites as required.
What You’ll do:
- Lead support and manage the execution of all clinical studies conducted by Cloud DX
- Coordinate study activities with external stakeholders (e.g. study sites research ethics boards etc.) to support the completion of clinical study objectives
- Act as a clinical monitor for studies to ensure that studies are conducted according to protocols Good Clinical Practices and applicable regulatory requirements.
- Author clinical study documentation for trial master files submission to regulatory authorities external publications industry societies etc.
- Establish standard operating procedures and templates for conducting managing and documenting clinical studies.
- Assist in the development of Cloud DX’s clinical program and strategy.
- Provide guidance and expertise to Cloud DX management in the area of clinical research.
- Update existing clinical trials procedures and work instructions to be compliant with ISO 14155:2020 and Health Canada’s MDR Part 3.
Bonus Points For:
- Formal training or professional designation in Clinical Research and study monitoring
- Familiarity with the Canadian and US healthcare system including health economics reimbursement etc.
- Knowledge of international clinical and regulatory requirements (e.g. ISO 14155 EU MDR etc.)
- Experience with medical device regulatory submissions (e.g. Health Canada FDA EU Notified Bodies etc.)
- Regulatory experience
- Prior experience in a start-up environment
Cloud DX is an equal opportunity employer. We thrive on diversity and are committed to creating an inclusive environment that represents a variety of backgrounds perspectives experiences and skills. All qualified applicants will receive consideration for employment without regard to race colour religion sex sexual orientation gender identity national origin or any other applicable legally protected characteristics in the location in which the candidate is applying.
Job Type: Contract