Saturday , September 30 2023

Sick Kids Employment – Clinical Research Project Coordinator

Website The Hospital for Sick Children

Job Description:

We are currently seeking a Clinical Research Project Coordinator to join the Clinical Trials Support Unit (CTSU) team, part of the Oncology/Bone Marrow Transplant/Cellular Therapy program at SickKids. In this role you will manage consortium, investigator initiated or industry-sponsored clinical trials. You will work collaboratively with a multidisciplinary oncology team of physicians, nurses, clinical research project coordinators and managers, and more. You will also be developing strong relationships and collaborating with external stakeholders including study sponsors, C17 Council, and all other 16 pediatric oncology/BMT/CT programs across Canada. You will be responsible for the coordination of various aspects of clinical research studies including regulatory work, patient enrollment, data submission, aspects of study activation and more. This is an exciting opportunity for you to use your project management skills and clinical trial knowledge to facilitate consortium, investigator-initiated and industry-sponsored clinical research trials in a dynamic and fast-paced oncology setting. Don’t miss out on the opportunity to work alongside the world’s best in paediatric cancer healthcare.

Job Responsibilities:

  • Prepare and submit regulatory documents (i.e., amendments, consent forms, REB application packages etc.) for ethics review throughout lifecycle of the study
  • Responsible for study data abstraction and submission in accordance with sponsor and other regulatory timelines.
  • On-call weekend support a few times per year may be required
  • Conduct study feasibility review; assist with tracking study budgets, closely collaborating with the budget associate, as necessary
  • Work with the legal and contracts department within SickKids to ensure clinical trials contracts and other documents are in place
  • Contribute to other areas and functions of the team, as necessary
  • Participate in educational initiatives concerning clinical trials and attend related meetings
  • Be an active member of the interdisciplinary team; collaborate and problem solve effectively
  • Build strong relationships with all (internal and external) stakeholders; maintaining positive relationships
  • Specimen submission: shipment of clinical trial tissue and blood samples
  • Liaise with other clinical research coordinators (CRCs) and managers, research nurses, physicians, other members of the health care team and regulatory personnel to ensure patient management and oversight of regulatory components of clinical trials
  • Screen, consent patients and enroll eligible patients on study as per study protocol
  • Monitor study compliance, collaborate with clinical staff to assure completeness and accuracy of documentation, facilitate use of the protocol as well as maintain quality assurance through accurate and timely data reporting
  • Participate in process improvement initiatives, including development of new SOPs and other processes for more efficient contact of clinical trials in accordance with institutional and regulatory requirements
  • Monitor serious adverse events or reactions, and report immediately to Principal Investigator. Follow-up on adverse events according to SickKids’ Policy. This includes filing reports with internal (REB), sponsors, external regulatory bodies and/or patients.

Job Requirements:

  • CCRP certification (Certified Clinical Research Professional) or willingness to write the examination
  • Minimum of 2 to 3 years related experience in clinical trials, including regulatory and clinical data management
  • Self motivated and able to work independently as well as within a team
  • Demonstrated exceptional interpersonal and communication skills
  • Clinical Research Program College Certificate or a university Masters degree an asset
  • Strong computer skills including experience with various electronic data capture systems
  • Prior experience in oncology; experience in paediatric oncology and phase 1 trials is a strong asset. Knowledge of medical terminology
  • Baccalaureate degree in a related discipline (i.e. Life Sciences or equivalent) required
  • High energy individual with excellent attention to details, organizational and analytic skills
  • Demonstrated ability to utilize critical thinking and problem-solving abilities

Job Details:

Company: The Hospital for Sick Children

Vacancy Type:  Full Time

Job Location: Toronto, ON, CA

Application Deadline: N/A

Apply Here