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clinical research associate
Posted on November 06, 2024 by Employer details bioLytical
Job details
*bioLytical* is hiring an experienced, versatile in-house Clinical Research Associate specializing in IVD and medical device to oversee all aspects of clinical trial management and execution, including generating study protocols, ethics applications and final reports. Reporting into the VP, Compliance, the Clinical Research Associate must be a self-starter, able to recognize logistical problems, initiate appropriate solutions, proactively identify, resolve/mitigate, and escalate issues on matters relating to clinical trial requirements, clinical evaluations and product related publications. *About bioLytical* bioLytical 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. bioLytical 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 been featured on BC?s Fastest Growing Companies six years in a row. bioLytical moved to a significantly larger, state-of-the-art facility in Richmond in 2020 to accommodate the extraordinary growth achieved through our team. *HOW YOU WILL CONTRIBUTE* - Demonstrate and integrate bioLytical product knowledge to design, create, and write trial protocols and study documentation including ethics applications for bioLytical products, and liaise with regulatory authorities. - Identify, evaluate, establish and close trial sites, and negotiate site budgets and agreements. - Steer meetings with contract research organization (CRO) and sites around clinical activities, such as: - Conducting and documenting study monitoring/site visits, coordinating project meetings, and implementing actions for sites that do not meet expectations, - Overseeing and documenting investigational product dispensing inventory and reconciliation. - Train and oversee site staff on bioLytical product tests, therapeutic areas, protocol requirements, proper source documentation, and case report form completion. - Lead the ethics committee approval process regarding the rights, safety, and well-being of trial subjects for all assigned bioLytical studies. - Order, track, and manage clinical and trial materials. - 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. *WHAT OUR IDEAL CANDIDATE WILL HAVE* - Bachelor?s degree in Biological Science or a related field. - Minimum 3 years of experience as a Clinical Research Associate. Medical device experience will be an asset. - 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 task 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. - Please note that this position is an on-site role based out of our Richmond, BC facility. *WHAT WE OFFER* - A competitive compensation package - Extended health benefits including dental - 100% employer contribution - Flexible working hours - Paid sick days - Bonus day off with pay on your birthday every year! - Complimentary reserved parking - Exercise room with a gym and sho- LocationRichmond, BC
- Workplace information On site
- SalaryNot available
- Terms of employment Full time
- Starts as soon as possible
- vacancies 1 vacancy
- Source indeed.com #9517422534
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