Senior Clinical Research Associate

at  Profound Medical

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.

EDUCATION AND CERTIFICATION:

• Bachelor’ s degree in health or medical sciences such as nursing,
• Master’ s degree preferred.
• Diploma or certificate in clinical research or > 3 years professional experience in Clinical Research Associate role.
• Strong preference given to candidates with SOCRA/CCRP or ACRP certification.

KEY ATTRIBUTES (EXPERIENCE, SKILLS AND TECHNICAL KNOWLEDGE):

• Clinical trial leadership experience
• Proven experience in administering and conducting clinical trials from startup to closeout.
• Proficiency in Good Clinical Practice (GCP) guidelines, ethics board policies, applicable regulatory requirements and all related processesProven 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.

GENERAL ACCOUNTABILITY:

The Senior CRA is a key member of the clinical trials team dedicated to
achieving and exceeding business objectives through efficient leadership and execution, high quality and timely delivery of all associated aspects of clinical trial operations from initiation to closeout.

DUTIES AND RESPONSIBILITIES:

• Review site contracts, budgets, and ethics board submissions.
• 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.
• Lead execution of data management plan, ensuring 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. Prepare reports and ensure corrective action.
• Advise and support Senior Clinical Management Team.
• Conduct training for colleagues or study team as requested.
• Fulfill other duties as required, including but not limited to tracking inventory and supplying study sites, and coordinating eligibility reviews
• Up to 25% travel to study sites