Clinical Research Associate

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. 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.

Requirements

• Establish relationship with study site personnel.
• Establish and maintain the Trial Master File ensuring copies of study documents including protocols, ethics approvals, patient-facing materials and site training and qualification are current and compliant.
• Ensure the study conduct, trial master file (TMF) and adverse event reporting are compliant with the ethics board approval, Good Clinical Practice (GCP) guidelines and applicable regulatory requirements.
• Ensure study data are accurate, complete, and verifiable through source data review/verification (SDR/SDV) and case report form (CRF) review as applicable, by on-site and remote monitoring activities. Resolve any discrepancies using Query Process.
• Gather analytics on clinical trial progress to ensure integrity of data collection and track project milestones.
• Perform site initiation visits, interim monitoring visits and close-out visits as needed.
• Provide support to Senior Clinical Management Team.
• Conduct training for site study teams, as required.
• Fulfill other duties as required.

Benefits

• Group RRSP
• Medical benefits paid by the employer