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 (CRPC) to lead and support clinical trials and observational research in childhood kidney disease. The CRPC will join the research program of Dr. Cal Robinson, Staff Nephrologist in the Division of Nephrology and Scientist-Track Investigator in the Child Health Evaluative Sciences (CHES) Program at SickKids. The program aims to improve treatments and long-term outcomes for children with kidney diseases, including nephrotic syndrome, chronic kidney disease (CKD), kidney transplantation, acute kidney injury and hypertension, using innovative clinical trial designs, advanced causal inference methods and population-based data.
The CRPC will coordinate a growing portfolio of active and planned studies, including:
- RESPONSE: a multicentre Bayesian adaptive randomized controlled trial (RCT) comparing reduced-dose and standard-dose steroids for childhood nephrotic syndrome relapses across Canadian sites.
- ADAPT-KIDS: a multicentre, double-blind, placebo-controlled Bayesian adaptive basket RCT of an SGLT2 inhibitor (dapagliflozin) in children with CKD and kidney transplant recipients.
- DEFENSE: a multicentre RCT of vitamin D supplementation for relapse prevention in childhood nephrotic syndrome.
- INSIGHT and CONSIST: a prospective Canadian cohort of children with nephrotic syndrome, and an international consortium harmonizing data from observational cohorts worldwide.
- Population-based health administrative data research: studies using Ontario and multi-provincial data to evaluate long-term outcomes and real-world treatment effectiveness in childhood kidney disease.
- KIDBP-Trials: the Canadian Childhood Kidney Disease and Blood Pressure Trials Network, which supports multicentre investigator-led and industry-sponsored trials across Canada.
The CRPC will primarily lead study activities at the SickKids site and, where SickKids is the coordinating centre, support participating sites with study start-up, regulatory documentation, training and data quality. The role works closely with the Principal Investigator (PI), research staff, trainees, clinical teams in the Division of Nephrology, methodologists, patient and family partners, and collaborators across Canada and internationally.
Here's What You'll Get To Do:
Study coordination and regulatory
- Coordinate the day-to-day conduct of clinical trials and observational studies in accordance with the protocol, ICH-GCP, Health Canada regulations and SickKids policies.
- Prepare and submit Research Ethics Board (REB) applications, amendments, annual renewals and safety reports; develop informed consent documents based on REB templates and institutional requirements.
- Support regulatory submissions and maintain essential documents, trial master files and study binders.
- Develop and monitor study timelines, workplans, recruitment targets and deliverables.
- Support participating sites as the coordinating centre, including start-up activities, site training, document management, query resolution and communication.
- Participate in audits, site visits and monitoring by SickKids, sponsors and regulatory bodies.
- Liaise with Pharmacy, laboratory medicine, Diagnostic Imaging, Health Records and other departments on investigational product management, specimen procurement and study procedures.
Participants and data
- Screen, recruit and consent children and families; confirm eligibility; and register and randomize participants.
- Conduct study visits, interviews and assessments, and arrange clinical follow-up as required by study protocols.
- Monitor, document and report adverse events and serious adverse events to the PI, REB and external bodies according to SickKids policy.
- Initiate and maintain research charts, source documentation and case report forms.
- Contribute to the design of case report forms and REDCap databases; perform and oversee data entry, cleaning and quality control; and support data preparation for analysis.
Program development, team and administration
- Assist the PI with grant applications, progress reports, presentations, abstracts and manuscripts.
- Conduct literature reviews and keep current with study literature and regulations governing clinical research.
- Support patient and family engagement activities, including collaboration with the Nephrotic Syndrome Patient and Family Advisory Council (NS-PACT).
- Co-supervise (with the PI) Clinical Research Assistants, students and volunteers, and assist with the training and orientation of new research staff.
- Foster collaborative relationships with healthcare teams at SickKids, participating centres, network partners and community organizations.
- Prepare purchase requisitions and invoices, and maintain budget records.
Here's What You'll Need:
Essential Requirements
- Master's degree (or equivalent professional degree) in clinical research, epidemiology, health sciences, public health or a related discipline, OR certification as a clinical research associate (e.g., SOCRA or ACRP).
- Minimum 2 years of clinical research experience.
- Working knowledge of ICH-GCP, TCPS 2 and REB processes.
- Excellent organizational skills, attention to detail and the ability to manage multiple studies, timelines and competing priorities.
- Effective written and verbal communication, interpersonal and facilitation skills, including comfort communicating with children and families.
- Ability to function independently with minimal supervision, yet collaboratively within a team.
- Proficiency with Microsoft Office applications.
- Demonstrates commitment and actions in advancing equity, diversity and inclusion objectives.
Preferred Qualifications
· Experience coordinating Health Canada-regulated and/or multicentre clinical trials.
· Experience in paediatric and/or nephrology research.
· Experience with REDCap or other database design and management.
· Basic data management or analysis skills in R.
· Experience with patient and family engagement in research.
Employment Type:
This is a 1.0 FTE temporary contract position of 1 year, with the possibility of renewal. The position is based at SickKids in Toronto, Ontario, and is hybrid, with 1-2 days per week of remote work. On-site presence is required for participant recruitment, study visits, and other in-person study activities.
Our Commitment to Diversity
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
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
Use this link to access full job description and application details: https://www.sickkids.ca/en/careers-volunteer/careers/
