Clinical Research Project Manager, Child Health Evaluative Sciences

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

We are seeking a highly qualified candidate for a Clinical Research Project Manager position in the Child Health Evaluative Sciences program in the Research Institute at the Hospital for Sick Children in Toronto, Canada. The Clinical Research Project Manager works closely with the Principal Investigator (PI) to plan and manage the overall research program and research team. This includes the long-term planning of on-going projects, day-to-day operations of on-going studies (ensures studies are proceeding according to regulatory and institutional guidelines and requirements), and development of new projects. In addition, they manage the personnel on the research team, comprised of clinical research coordinators and assistants, trainees and volunteers, including on-going training and supervision, conducting performance appraisals, and organizing communication strategies, and team meetings. Experience in randomized control trial study coordination is an asset. This includes coordinating patient recruitment and data collection, study administration, preparing consents and paperwork required by the Research Ethics Board, and organizing data entry and analysis. The Clinical Research Project Manager will also assist in the preparation of study results, including presentations, progress reports, and manuscripts. Research studies will will cover a diverse portfolio of infectious diseases using a variety of study designs.

• Collaborate with PI and an interdisciplinary clinical team to run research studies, and develop/review grant applications, new research proposals, report preparation, presentations, manuscripts and study protocols
• Prepare protocols for use and develop case report forms and/or questionnaires
• Organize science reviews and track deadlines
• Keep abreast of regulations and policies governing clinical research and communicating to staff and research team members
• Develop policies and procedures related to the research program, ensuring external regulations and guidelines are followed
• Develop informed consent documents based on regulations, REB consent templates and institutional requirements. Submit documents to REB; following- up on queries and changes. Prepare annual follow up for resubmission, making and submitting changes based on protocol amendments as required
• Develop study binders for clinical program and study team use and ensure they are kept up to date
• Participate in audits, site visits and monitoring by SickKids and other regulatory bodies
• Supervise literature reviews and keep current with study literature
• Supervise database development and entry and locking database once clean
• Develop programming to produce regular database reports
• Develop and monitor timelines for existing studies and balance the demands of multiple projects
• In multi-centre trials, manage the overall study, including participation in selection, training, monitoring and ongoing communication with other studies, and organizing Investigator meetings
• Develop quality control guidelines for studies ¿ e.g. eligibility confirmation, protocol compliance, scheduling of re-evaluations
• Monitor serious adverse events or drug reactions and reporting to PI. Follow-up on adverse events including filing reports with internal and external regulatory bodies (REB), notification of collaborators, and/or patients
• Design/develop promotional strategies, including newsletters and letters to parents
• Oversee recruitment and patient contacts
• Encourage and foster collaborative relationships with the healthcare team at SickKids, other participating centres and government and community agencies
• Recruit, train and supervise project staff
• Actively participate in departmental/program meetings or rounds to acquire and disseminate knowledge and to profile clinical research
• Develop, manage and forecast study budgets
• Develop in-services on study requirements
• Monitor staff performance and assist PI with annual performance appraisals