Associate, Clinical Research
Top Benefits
About the role
bioLytical is hiring an experienced Clinical Research (CR) Associate. You will support in-house clinical operations and assists in the planning, development, and implementation of multiple studies in support of bioLytical’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 escalate issues on matters relating to clinical trial requirements, clinical evaluations and bioLytical 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.
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 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 bioLytical 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 do not meeting 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.
WHAT YOU WILL BRING
- 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 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.
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!
- 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 barbeques
- 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
bioLytical's pay range is based on multiple factors including experience, education, job-related skills, and equity within the team or organization.
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.
CORE VALUES
INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes the initiative on projects.
NEVER SAY NEVER : Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.
SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.
TAKES OWNERSHIP of goals, decisions, actions, and results: Arrives on time and prepared, leads by example, follows through on commitments.
INSPIRED to excel: Demonstrates a passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business.
#clinicalresearch #protocolwriting #medicaldevice #ISO13485 #ISO14971 #clinicaloperations #regulation #USFDA
About bioLytical
Biolytical Laboratories Inc. based in Richmond, BC, Canada is a privately-owned Canadian Company federally incorporated in 2002. Our mission is to improve the quality of people’s lives by providing innovative solutions for infectious disease diagnosis, the first step in the linkage of patients to appropriate care and treatment. Today, the company sells and markets its INSTI™ HIV test supported by worldwide regulatory approvals including US FDA approval, Health Canada approval and CE mark in Europe.
Our product provides a highly accurate HIV test result in as little as 60 seconds which translates into a compelling value proposition for patients, healthcare professionals, payers and public health organizations. We have an active R&D program and our pipeline includes INSTI™ tests for diseases such as Hepatitis C and Syphilis. The company also provides contract services to adapt the INSTI™ platform to meet custom functional and technical diagnostic testing requirements. Our vision is to be a global leader in the research, development and commercialization of rapid, point-of-care in vitro medical diagnostic devices.
Associate, Clinical Research
Top Benefits
About the role
bioLytical is hiring an experienced Clinical Research (CR) Associate. You will support in-house clinical operations and assists in the planning, development, and implementation of multiple studies in support of bioLytical’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 escalate issues on matters relating to clinical trial requirements, clinical evaluations and bioLytical 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.
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 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 bioLytical 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 do not meeting 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.
WHAT YOU WILL BRING
- 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 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.
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!
- 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 barbeques
- 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
bioLytical's pay range is based on multiple factors including experience, education, job-related skills, and equity within the team or organization.
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.
CORE VALUES
INNOVATION in what we do, how we do it and how we think: Contributes new ideas, challenges the status quo, takes the initiative on projects.
NEVER SAY NEVER : Stays engaged until the goal is reached or project is completed. Overcomes barriers. Cares so much about the task at hand that the impossible is made possible.
SENSATIONAL to our clients, to our partners, to each other: Spirited team player, who adapts to new situations quickly and is beyond reliable.
TAKES OWNERSHIP of goals, decisions, actions, and results: Arrives on time and prepared, leads by example, follows through on commitments.
INSPIRED to excel: Demonstrates a passion for INSTI, our people and our projects. Is not complacent, shares knowledge freely, exhibits awareness of self, their surroundings, and the business.
#clinicalresearch #protocolwriting #medicaldevice #ISO13485 #ISO14971 #clinicaloperations #regulation #USFDA
About bioLytical
Biolytical Laboratories Inc. based in Richmond, BC, Canada is a privately-owned Canadian Company federally incorporated in 2002. Our mission is to improve the quality of people’s lives by providing innovative solutions for infectious disease diagnosis, the first step in the linkage of patients to appropriate care and treatment. Today, the company sells and markets its INSTI™ HIV test supported by worldwide regulatory approvals including US FDA approval, Health Canada approval and CE mark in Europe.
Our product provides a highly accurate HIV test result in as little as 60 seconds which translates into a compelling value proposition for patients, healthcare professionals, payers and public health organizations. We have an active R&D program and our pipeline includes INSTI™ tests for diseases such as Hepatitis C and Syphilis. The company also provides contract services to adapt the INSTI™ platform to meet custom functional and technical diagnostic testing requirements. Our vision is to be a global leader in the research, development and commercialization of rapid, point-of-care in vitro medical diagnostic devices.