Clinical Research Associate

Posted One Month Ago
Be an Early Applicant
Mississauga, ON, CAN
Hybrid
60K-75K Annually
Junior
Artificial Intelligence • Hardware • Healthtech • Robotics
The Role
Manage clinical trial operations from startup to closeout including site management, SIV/IMV/closeout visits, TMF maintenance, source data review/verification, safety reporting, site training, data and quality oversight, risk identification/mitigation, and regulatory/GCP compliance. Engage sites, review contracts/budgets/ethics submissions, and drive process improvements to ensure inspection-ready documentation and trial integrity.
Summary Generated by Built In

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.

General Accountability:
The Clinical Research Associate will be responsible for analyzing, questioning, and improving how work gets done while demonstrating strong foundational CRA capabilities, meeting business objectives through efficient, quality trial execution from startup to closeout.

Duties and 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

Education

  • Bachelor’s degree in biomedical sciences required. MSc (thesis-based preferred) or equivalent research experience.

Certifications

SOCRA/CCRP or ACRP certification preferable/ completion of a clinical research graduate certificate.

Key Attributes

  • 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
  • Ability to travel for site visits, monitoring visits, SIVs, and investigator interactions up to 60% of the time within Canada and United States.

We thank you for your interest in Profound Medical. Please note only candidates that are short-listed will be contacted.

The expected annual salary range for this role is $60,000 - 75,000 CAD. Actual compensation will be determined based on experience, qualifications, and job-related factors. This role may also be eligible for participation in the company’s benefits programs, such as a group RRSP and medical benefits paid by the employer.

We strive to promote diversity and equal opportunity in the workplace and encourage applications from all qualified individuals, including those with disabilities. If selected to participate in the recruitment, selection, and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require.

Skills Required

  • Bachelor's degree in biomedical sciences
  • Minimum of 1-3 years clinical research or CRA experience
  • Experience administering and conducting clinical trials from startup to closeout
  • Experience conducting site initiation visits, monitoring visits, and close-out visits on-site and remotely
  • Proficiency in Good Clinical Practice (GCP) guidelines and applicable regulatory requirements
  • Trial Master File (TMF) maintenance and inspection-ready documentation experience
  • Source data review / source data verification (SDR/SDV) and data quality management experience
  • Knowledge of adverse event reporting procedures and regulatory requirements
  • Ability to travel up to 60% within Canada and the United States for site visits
  • Strong written and interpersonal communication skills
  • Proven ability to build and maintain relationships with study site personnel
  • MSc (thesis-based) or equivalent research experience
  • SOCRA/CCRP or ACRP certification or completion of a clinical research graduate certificate
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The Company
187 Employees
Year Founded: 2008

What We Do

Profound Medical Corp. is a commercial-stage medical technology company that develops and markets AI-powered, MRI-guided, incision-free therapeutic systems for the ablation of diseased tissue. Its flagship TULSA-PRO system provides customizable treatment for prostate cancer and BPH, while Sonalleve offers non-surgical options for uterine fibroids and bone metastases. The company aims to provide safe, minimally invasive treatment options that preserve patients' quality of life.

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