Clinical Research Project Coordinator - RI

at  SickKids

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 Clinical Research Project Coordinator (CRPC) coordinates multiple concurrent clinical research studies according to regulatory and institutional guidelines and requirements as a team member of the SickKids Clinical Research Coordinator Services group, Clinical Research Operations. This includes general study administration and organization, coordinating participant recruitment, consent, data entry, data collection and documentation including Research Ethics Board (REB) submissions. The CRPC also assist in the preparation of interim data, including presentations, progress reports, and manuscripts. The CRPC will report to the Senior Manager, Clinical Research Facilities and Services, Clinical Research Operations, and the Clinical Research Program Manager.
The CRPC will work closely with clinical coordinators, SickKids Clinical Research Centre nurses, SickKids Central Biobank research technologists, SickKids clinical research teams and clinician scientists, affiliated institutes, and collaborative networks. The successful candidate will have the opportunity to contribute to research into new therapeutic agents, improve standard of care best practices, and build experience managing a diversity of trials.

• Assist the Senior Manager Clinical Research Facilities and Services and/or Principal Investigator(s) (PI) in the preparation of new research proposals and contribute to the preparation of reports and/or presentations.
• Assist in the creation and editing of study and informed consent documents, electronic and paper case-report forms and/or questionnaires, and ensure compliance with local and global regulations, and institutional policies. The CRPC will develop and submit applications and amendments to the REB; follow up on queries and changes.
• Develop and maintain study binders and other electronic databases for the clinical department and study team.
• Design and planning of electronic data capture (EDC) databases, in conjunction with Principal Investigator(s) and/ or Database Analysts and ensure the quality of the database, including data entry, analysis, and cleaning.
• Provide information and documentation for potential study participants (consents, participant eligibility items, required pre-study testing, roadmaps).
• Confirm eligibility of the participant (i.e. confirm eligibility criteria are satisfied, signed consent available) and register participants.
• Initiate and maintain a research chart that will include original consent, participant protocol documentation, general correspondence, and case report forms.
• Develop capabilities and knowledge of EPIC, SickKids¿ electronic patient records platform.
• Organize the collection of biologic specimens, tests and reports from relevant SickKids departments including SickKids Clinical Research Centre, Department of Paediatric Laboratory Medicine (DPLM), Diagnostic Imaging, Health Records, etcetera and transport of materials to SickKids Central Biobank and/or laboratories.
• Monitor serious adverse events or drug reactions, and report to Principal Investigator. Follow-up on adverse events, including filing reports with internal and external regulatory bodies (REB), notification of collaborators, and/or patients.
• Participate in audits, site visits and monitoring by SickKids and other regulatory bodies or industry sponsors.
• Perform participant interviews and assessments as required by study protocols.
• Draft Standard Operating Procedures and organize materials to facilitate protocol adherence, including study binders and checklists of eligibility.
• Assist in training and orientation of new research staff.
• Maintain and monitor study timelines and budget.