Clinical Research Associate

1 week ago

Vancouver, Canada MetaOptima Full time

MetaOptima is making a difference in the lives of millions as we revolutionize the dermatology industry with artificial intelligence-powered software solutions for faster, more effective, and affordable care. MetaOptima is full of passionate, innovative people who thrive on working together as a team to build smart, life-saving technologies for medical professionals and their patients. Our casual, open-office culture welcomes fresh ideas from the minds of doers. Join our fast-growing startup to add your voice to our vision while working with a cool group of people set on making their mark on the world. We take pride in what we’ve accomplished together, and can’t wait to see how you’ll help us grow.

We are looking for a highly motivated clinical research associate interested in taking ownership of our medical device clinical trial activities. The incumbent is expected to be in charge of clinical project management in various countries.

**Qualifications and experience**:
- Bachelor’s degree in life sciences-
- Must have 3 years experience in planning and execution of clinical trials - medical device pivotal clinical trial experience preferred-
- Knowledge of ICH-GCP, ISO 14155 and US FDA regulations pertaining to medical device clinical trials-
- Prior experience in managing a clinical trial project in a similar capacity is essential-
- Strong project management and interpersonal skills-
- Excellent verbal and written communication skills-
- Attention to detail with the ability to work independently in a fast paced environment- SoCRA or ACRP certification will be an asset

**Responsibilities will include**:
- Development of clinical project plan including the monitoring plan-
- Communicating with Principal Investigators, IRB and central laboratories and serve as the main point of contact-
- Conduct site selection, qualification, initiation, training, monitoring and close-out activities-
- Preparation and ongoing review of clinical trial budget-
- Preparation of clinical trial documentation including SOPs, CRFs, IB, monitoring plan, monitoring reports and clinical investigation reportPerformance of site audits and monitoring as required-
- Ensure adherence to study protocols, SOPs, and compliance with GCP guidelines, FDA regulations and IRB requirements.-
- Ensure timely reporting of adverse events-
- Implementation and maintenance of clinical trial quality management system including taking corrective and preventive actions- Maintain the trial master file and required records in a timely manner including transfer of site documents and ensuring the quality of the trial master file
- Clinical trial registration at clinicaltrials.gov

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