Clinical Research Associate

Profound Medical•Mississauga, ON

16d•Hybrid

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

Minimum 2 years professional experience in clinical research or trial support
Knowledge of clinical trial operations and regulatory standards (e.g., GCP, ICH)
Strong organizational and project management skills
Outstanding communication and interpersonal skills
Ability to manage multiple tasks simultaneously and adapt to shifting priorities

Nice To Haves

Proficiency in Microsoft Office Suite and clinical trial management systems is preferred
Experience working with cross-functional teams and familiarity with prostate cancer in medical device trials setting.

Responsibilities

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.