Clinical Research Jobs in Vancouver – Randstad is Hiring – Apply below
Clinical Research Jobs in Vancouver, Randstad is Hiring, We are seeking a Clinical Research Lead for a newly created position with a well-established biomed client of ours in the Vancouver area. This position will oversee virtual site visits, generate, and prepare study protocols, ethics applications, and final reports, oversee study database design and management, and liaise with study sites and investigators regarding all aspects of clinical trial management and execution.
Job Posting: Clinical Research Leader – Medical Device
Company: Randstad
Location: Vancouver, British Columbia
Salary: $85,000 – $100,000 per year
Advantages:
- Onsite role
- Opportunities for career advancement
- Excellent benefits package
Responsibilities:
- Lead by example, integrate product knowledge to design, create, and write trial protocols and study documentation including ethics applications for products, and liaise with regulatory authorities.
- Coordinate the day-to-day operation within the Clinical Research team; Plan and manage personnel and resource requirements.
- Guides the development of and provides oversight of clinical research project timelines.
- Identify, evaluate, establish, and close trial sites, and negotiate site budgets and agreements.
- Supervise study sites and activities to ensure adherence to appropriate industry protocols and terms of study.
- Train and oversee site staff on 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 that IP has been dispensed and administered according to protocol.
- Oversee study database design and management.
- Ensure compliance with SOPs local regulations, and ICH and GCP guidelines.
Qualifications:
- Bachelor’s degree in Biological Science or a related field.
- Minimum 5 years of experience as a Clinical Research Associate.
- Knowledge of the diagnostics industry, terminology, 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.
- Available to travel extensively and on short notice, and able to manage travel schedules. (Post-COVID)
- Experience liaising with Regulatory Authorities i.e. US FDA, Health Canada, and Notified Bodies will be an asset
- Knowledge of Canadian, US, and European regulations, ISO 13485, and ISO 14971 will be an asset.
How to Apply : If you would like to be considered for this opportunity please forward your resume via email to Nick Paraskeva at [email protected]
