ABOUT SICKKIDS

Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) is one of the largest and most respected paediatric healthcare centres in the world. As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading-edge research and education. Our reputation would not have been built - nor could it be maintained - without the skills, knowledge and experience of the extraordinary people who come to work here every day. SickKids is committed to ongoing learning and development, and features a caring and supportive work environment that combines exceptionally high standards of practice.
When you join SickKids, you become part of our community. We share a commitment and determination to fulfill our vision of Healthier Children. A Better World.
Don’t miss out on the opportunity to work alongside the world’s best in paediatric healthcare.

POSITION DESCRIPTION

We are seeking a Clinical Research Project Coordinator (CRA II) to join the Clinical Trials Support Unit (CTSU) team, part of the Haematology/Oncology program at SickKids.
In this role you will manage consortium, investigator initiated and/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 trials 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.

• Prepare and submit regulatory documents (i.e., amendments, consent forms, REB application packages etc.) for ethics review throughout lifecycle of the studyScreen, 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
• 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.
• Conduct study feasibility review; assist with tracking study budgets, closely collaborating with the budget associate, as necessary
• Liaise with other clinical research coordinators (CRCs) and managers, research nurses, physicians, other members of the clinical team and regulatory personnel to ensure patient management and oversight of regulatory components of clinical trials
• Responsible for study data abstraction and submission in accordance with sponsor and other regulatory timelines.
• Work with the legal and contracts department within SickKids to ensure clinical trials contracts and other documents are in place
• Participate in process improvement initiatives, including development of new SOPs and other processes for more efficient conduct of clinical trials in accordance with institutional and regulatory requirements
• Participate in sponsor audits and inspections and contribute to audit preparatory work, as needed
• Specimen submission: shipment of clinical trial tissue and blood samples
• 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; maintain positive and productive work relationships
• Contribute to other areas and functions of the team, as necessary