Clinical Research Associate
About The Position
Our mission is to profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation, and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with minimal side effects. If you share our values and want to work in a collaborative results focused culture and want to make a profound impact in healthcare and your career, here is your chance.
Requirements
- Bachelor’s degree in biomedical sciences required.
- MSc (thesis-based preferred) or equivalent research experience.
- Ability to think critically beyond following process
- Minimum of 1 - 3 years of experience
- Strong written communication skills that are clear, concise, and logical
- High level of initiative, ownership, and work ethics
- Ability to structure and present information clearly
- Attention to detail combined with big-picture thinking
- Experience in administering and conducting clinical trials from startup to closeout
- Proficiency in GCP guidelines, ethics board policies, applicable regulatory requirements, and all related processes
- Proven ability to establish and maintain relationships with study site personnel
- Proficiency in data management and quality management
- Knowledge of adverse event reporting procedures and applicable regulatory requirements
- Experience in conducting site initiation visits, monitoring visits, and close-out visits - both on-site and remotely
- Outstanding interpersonal and communication skills
- Ability to manage multiple tasks simultaneously, track project milestones, and ensure timely delivery of results
- Strong attention to detail
- Strong ability to work both independently and collaboratively
Nice To Haves
- SOCRA/CCRP or ACRP certification preferable/ completion of a clinical research graduate certificate.
Responsibilities
- Execute core clinical operations activities with attention to both detail and underlying context: site management, SIV, IMV, closeout visits, Trial Master File (TMF) maintenance, etc
- Participate in review of site contracts, budgets, and ethics board submissions
- Build and maintain effective relationships with study personnel
- Investigate issues independently, identify root causes, and propose solutions
- Ensure study data are accurate, complete, and verifiable through source data review/verification (SDR/SDV) by on-site, remote, or centralized monitoring activities
- Analyze site and study data to identify inconsistencies, trends, or potential risks and develop mitigation strategies
- Engage sites as a thought partner to improve protocol understanding and execution
- Communicate findings, issues, and recommendations in a clear, structured, concise, and results-generating manner
- Maintain TMF documentation that is clear, logical, compliant, and inspection-ready
- Continuously seek opportunities to improve processes, clarity, and efficiency
- Ensure that the study conduct, TMF, and adverse event reporting are compliant with the ethics board approval, Good Clinical Practice (GCP) guidelines, and all applicable local regulatory requirements
- Conduct training for colleagues or study team as requested
- Fulfill other duties as required and requested by the company
Benefits
- group RRSP
- medical benefits paid by the employer
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
