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

The Comprehensive Epilepsy Program within the Division of Neurology is seeking a Clinical Research Project Coordinator (CRPC) to join our team. The CRPC will work on a variety of industry-sponsored clinical trials and other investigator-initiated clinical research studies, including registry, observational and retrospective studies. The CRPC will coordinate studies according to regulatory and institutional guidelines and requirements. This includes coordinating patient recruitment, data collection, data entry and analysis, study administration, preparing informed consent documents and other paperwork required by the Research Ethics Board (REB). The CRPC also will assist in the preparation of study results, including presentations, progress reports, and manuscripts.

• Assist the Principal Investigator (PI) in new research proposals, preparation of grant applications and scientific review process.
• Conduct literature reviews and keep current with study literature.
• Contribute to preparations of study reports, presentations, and manuscripts.
• Keep abreast of regulations and policies governing clinical research.
• Read and have a general knowledge of study protocols and study measures.
• Develop informed consent documents based on regulations, REB templates and institutional requirements.
• Prepare and submit REB applications (i.e., initial application, amendments, annual reviews) for ethics review throughout the lifecycle of the study.
• Prepare and maintain investigator site files and regulatory study binders for study team use.
• Organize materials to facilitate protocol adherence, including study binders and checklists of eligibility.
• Assist with database design, including case report forms and/or questionnaires. Ensure the quality of the database and supervise database cleaning.
• Screen, consent and enroll eligible participants as per study protocols.
• Coordinate study visits, perform participant interviews and assessments, and collect data as required by study protocols.
• Organize the procurement of biological specimens and tests from relevant departments.
• Perform/assist with data entry and analysis.
• Monitor serious adverse events or reactions and report immediately to PI. Follow-up on adverse events including filing reports with internal and external regulatory bodies, notification of collaborators and/or patients.
• 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 audits, site visits and monitoring by SickKids and other regulatory bodies or industry sponsors.
• Liaise with other clinical research project coordinators 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.
• Work with the legal and contracts departments within SickKids to ensure study contracts and budgets are in place.
• Encourage and foster collaborative relationships with the healthcare team at SickKids, other participating centres, and government and community agencies.
• Attend relevant departmental meetings or rounds to increase knowledge and understanding.