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Clinical Research Associate-II

Perimeter Medical Imaging

Perimeter Medical Imaging

Canada · Toronto, ON, Canada · Canada · Zaventem, Belgium
Posted on Friday, June 7, 2024


Perimeter Medical Imaging AI is a medical technology company driven to transform cancer surgery with its ultra-high resolution imaging technology to achieve our mission of advancing the standard of care, improving patient outcomes, and reducing healthcare costs. Our ultra-high-resolution, real-time, advanced imaging tools address areas of high unmet medical need.

With headquarters in Toronto, Canada and U.S. headquarters in Dallas, Texas, Perimeter Medical Imaging (TSXV:PINK)(FSE:4PC) has launched the next generation of imaging technology that allow surgeons to visualize microscopic tissue structures with unparalleled clarity in the operating room.

Job Description

We are hiring a Clinical Research Associate-Medical Device (CRA) to join our Clinical Affairs team. As a Clinical Research Associate your main area of responsibility will be supporting clinical studies, preparing essential documents, traveling to clinical sites to monitor study documents, and following good clinical practice and the company’s standard operating procedures to ensure accurate and reliable clinical study data.

Day-to-day activities will include supporting on-site clinical and procedural activities, aiding in the content development of study material, and being a driving force behind clinical trial compliance. You will be responsible for training clinicians on the study protocol, source data verification of study documents, preparation and submission to local and central IRBs, as well as training new members of the clinical team and ensuring that feedback from the field is reliably and effectively communicated back to other functional areas of the company.

Responsibilities shall include, but not be limited to:

  • Conduct source verification of information captured on Case Report Forms and verify Informed Consent Forms for accuracy and completeness
  • Serve as the primary point of contact for investigative sites, manage query resolution, support Trial Master File activities, participate in Investigators’ Meetings, and complete other project tasks in accordance with study timelines and budget
  • Review and ensure that all essential study documents and device accountability records are accurate and complete
  • Direct site qualification, initiation, monitoring and closeout visits, and create documentation of such through accurate and detailed visit reports
  • Collate and track site protocol deviations and non-compliance for study team review
  • Investigate and resolve data discrepancies in a timely manner
  • Coordinate or manage, either directly or through supervised delegation, external vendors, clinical site re-supply, overall data quality, and overall central records quality (e.g. eTMF, SOPs)
  • Strong working knowledge of FDA regulations and GCP compliance
  • Ensure clear written communication to clinical sites and project team members through accurate and timely monitoring reports, follow-up letters, and general correspondence
  • Ensure that all study staff are appropriately trained and prepared to conduct the clinical study in accordance with the IRB approved protocol and applicable regulations
  • Ensure any identified non-compliance issues are addressed, clearly communicated, appropriately documented and escalated as warranted
  • Assist with the development and implementation of study-specific monitoring and reporting procedures, methods, and guidelines
  • Schedule and plan day-to-day activities to include study monitoring visits, timely completion of high-quality trip reports, and active management of all deliverables
  • Collaborate with internal cross-functional teams and external clinical study sites including CRO’s

Required Qualifications

  • BA/BS required
  • Minimum of 1 years of clinical research experience with independent field monitoring
  • Medical Device industry experience and previous experience with oncology (solid tumor) preferred
  • Strong knowledge of Good Clinical Practice (GCP) and FDA regulations
  • Ability to successfully manage competing priorities and adapt quickly to changing priorities
  • High-level time management and organizational skills and excellent written and verbal communication skills
  • Experience with EDC systems, electronic trial master files (eTMFs) and other clinical trial databases and systems
  • Effective communication both written and verbal
  • Proficiency with Microsoft Word, Excel, and PowerPoint
  • Lives near a major airport and has a valid driver’s license
  • Ability to travel up to approximately 80%

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Perimeter Medical AI is committed to your success and providing opportunities for career and professional advancement. We maintain a fun and outgoing, yet professional environment that truly values our employees. As a part of our commitment to inclusivity, diversity, equity and accessibility, our goal is a workforce built on respect that reflects the communities we serve. We thank all applicants for their interest in Perimeter Medical AI but only those selected for an interview will be contacted.

Perimeter Medical Imaging AI is an equal opportunity employer and supports workforce diversity. Perimeter welcomes and encourages applications from people with disabilities. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.

We are proud to be in compliance with the Accessibility for Ontarians with Disabilities Act (AODA), 2005 and the Integrated Accessibility Standards Regulation. We are happy to honor accommodations at any part of the recruitment process and invite you to let us know how we can help.

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