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
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Reporting to the Labatt Family Heart Centre Clinical Research Manager, the Clinical Research Project Manager works closely with the Heart Centre Principal Investigators (PI) to plan and project manage new and ongoing clinical research studies. This includes the long-term planning of on-going projects, day-to-day operations of on-going projects (REB/Health Canada Applications, study start up, recruitment, closeout, protocol development, study budgets, monitoring and tracking study compliance/timelines/milestones). The successful candidate will develop close working relationships with the medical and health care professional staff that provide clinical care to the study patients, both at the SickKids and other institutions.
Here's what you'll get to do
Collaborate with PIs in the development and review of study protocols, regulatory submissions, research agreements, report preparation, presentations, and grant applications as needed
Develop case report forms and/or questionnaires
Track deadlines
Keep abreast of regulations and policies governing clinical research and communicate these policies to research team members
Develop informed consent documents based on regulations, REB consent templates and institutional requirements.
Prepare REB applications including new applications, amendments, SAE reporting and renewals/closures. Submit documents to REB; following- up on queries and required application changes.
Develop study binders and Trial Master Files for study team use and ensure they are kept up to date
Participate in audits, site visits and monitoring by SickKids and other regulatory bodies
Keep current with study literature
Complete data entry as required
Develop and monitor timelines for existing studies and balance the demands of multiple projects
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
Carry out patient recruitment
Encourage and foster collaborative relationships with the healthcare team at SickKids, other participating centres and other project stakeholders
Develop, manage and forecast study budgets for industry sponsored and investigator initiated regulated and non-regulated trials
Develop training sessions on study requirements
May be required to provide oversite and training of volunteers and trainees
Here's what you'll need
Bachelor's degree in Science, Health Sciences or related field
Master's degree in relevant research field considered an asset
Minimum of three years' experience working as a Clinical Research Project Coordinator or equivalent
Previous experiences carrying out Health Canada Regulated drug and/or device trials
Certification as a clinical research professional (e.g., SOCRA certificate) preferred
Previous experience with protocol development, consent form development and previous experience developing and submitting REB application required
Previous experience in the development of REDCap surveys/questionnaires, databases, etc considered an asset
Familiarity with finance management and industry sponsored budget development/negotiation an asset
Ability to function both independently and collaboratively within a team
Effective communication, interpersonal, facilitation and project management skills
Strong leadership qualities
A commitment to understanding and aiding in the pursuit of equity, diversity & inclusion
Here's what you'll love
This position is eligible for employee benefits coverage including but not limited to; health, dental and life insurance. The full benefits package will be discussed at the time of offer.
A focus on employee wellness with our new Staff Health and Well-being Strategy. Self-care helps us support others.
A hospital that welcomes and focuses on Equity, Diversity, and Inclusion.
The opportunity to make an impact. Regardless of your role or professional interest, you will be making a difference at SickKids and contributing to our vision of Healthier Children. A Better World*. For more on why you'll love working at SickKids, visit our careers site.
Employment Type:
Temporary full time
1.00FTE
Year + 1 day contract
Our Commitment to Diversity
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SickKids is committed to championing equity, diversity and inclusion in all that we do, fostering an intentionally inclusive and culturally safe environment that reflects the diversity of the patients, families and communities we serve. Learn more about workplace inclusion.
Accessibility & Accommodation
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If you require accommodation during the application process, please reach out to our aSKHR team. SickKids can provide access and inclusion supports to eligible candidates to support their full engagement during the interview and selection process as well as to ensure candidates are able to perform their duties once successfully hired. If you are invited for an interview and require accommodation, please let us know at the time of your invitation to interview. Information received related to access, inclusion or accommodation will be addressed confidentially.
How To Apply
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Technical difficulties? Email ask.hr@sickkids.ca with a short description of the issues you are experiencing. We will not accept resumes sent to this inbox but we are happy to respond to requests for technical assistance.
Tip:
Combine your cover letter and resume into
ONE
document of 20 pages or less as you cannot upload multiple documents as part of your application.
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