Associate, Clinical Research

bio Lytical is hiring an experienced Clinical Research (CR) Associate. You will support in-house clinical operations and assist in the planning, development, and implementation of multiple studies in support of bio Lytical
’s product portfolio. Working closely with the Vice President, Compliance, the CR Associate must be able to recognize logistical problems, initiate appropriate solutions, proactively identify, resolve/mitigate, and elevate issues on matters relating to clinical trial requirements, clinical evaluations and bio Lytical product related publications.

You will play a vital role in driving forward our mission to get people tested with the best technology on the market, living the Core Values through and through.

Demonstrate and integrate bio Lytical product knowledge to design, create and write trial protocols and study documentation including ethics applications for bio Lytical products and liaising with regulatory authorities.

Conduct data analysis, compile and generate scientific reports, regulatory documentation, and research‑related documents.

Ensure study sites and activities adhere to appropriate industry protocols and terms of study.

Train and oversee site staff on bio Lytical product tests, therapeutic areas, protocol requirements, proper source documentation, and case report form completion.

Liaise with the ethics committee regarding the rights, safety, and well‑being of trial subjects.

Conduct and document study monitoring/site visits, coordinate project meetings and implement actions for sites that do not meet expectations.

Order, track, and manage clinical and trial materials.

Oversee and document investigational product dispensing inventory, and reconciliation.

Protect subjects’ confidentiality, update information, and verify IP have been dispensed and administered according to protocol.

Oversee study database design and management.

Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.

Bachelor’s degree in Biological Science or a related field.

Minimum 3 years of experience in clinical operations.

Knowledge of the diagnostics industry, terminology, and practices and FDA regulations and their practical implementation.

Strong background in statistical data collection, validation, editing and analysis techniques.

Superior problem solving, deductive reasoning and decision‑making skills.

Strong verbal and written communication skills.

Proficient computer skills, with Microsoft Office Word, Excel, and PowerPoint.

Good time management and ability to prioritize tasks and accomplish set goals efficiently.

Experience liaising with Regulatory Authorities i.e. US FDA, Health Canada, Notified Bodies will be an asset.

Knowledge of Canadian, US and European regulations, ISO 13485 and ISO 14971 will be an asset.

A competitive compensation package.

Bonus day off with pay on your birthday every year!

Full‑size in‑house fitness gym and shower facilities.

Complimentary reserved parking.

Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun.

A chance to show off your dance moves and singing voice at the company parties and jump in to score a victory or lead the way in our outdoor games at the summer barbecues.

The opportunity to join an ‘off the charts’ foodie culture in our large kitchen and try out your favourite recipes or enjoy the culinary delights as they hit the share table.

The annual base salary for this job ranges from:

$68,000‑$80,000.

bio Lytical
’s pay range is based on multiple factors including experience, education, job‑related skills, and equity within the team or organization.

bio Lytical Laboratories Inc. is a privately‑owned Canadian company focused on the research, development and commercialization of rapid in‑vitro medical diagnostics using its proprietary INSTI® technology platform.
bio Lytical has won several local and industry awards, including BC Exporter of the Year in 2019 and the Globe and Mail’s Fastest Growing Companies list in 2020. We have been named Lifesciences BC’s Growth Stage Med Tech Company of the Year and have…