City : Toronto

Category : Full Time

Industry : Healthcare

Employer : The Hospital for Sick Children

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.

Posting Description

The SickKids Genetic Medicines Program is a core priority within the Advanced Therapeutics initiative of Precision Child Health at SickKids. The Clinical Research Project Coordinator (CRPC) will support the coordination of research studies and clinical trials in accordance with regulatory, institutional, and study-specific requirements.

This role includes coordinating patient recruitment, data collection, study administration, data entry and analysis, and the preparation of consent forms and Research Ethics Board documentation. The CPRC will also support the preparation of study outputs, including presentations, progress reports, and manuscripts.

The Genetic Medicines Program conducts a broad range of studies across diverse patient populations, including natural history studies, sponsor-initiated genetic medicine clinical trials, and academically sponsored investigator initiated clinical trials (IITs).

Here's What You'll Get To Do  

·       Support the expansion of pediatric IIT and Phase I'III clinical trials within the Genetic Medicines Program while independently managing multiple ongoing investigator-initiated and industry-sponsored studies, including complex genetic medicine trials.

·       Lead all aspects of study start-up, including protocol development and review, REB submissions, consent/assent drafting, source document creation, hospital approvals and quotes, regulatory documentation, and establishment of comprehensive study regulatory binders.

·       Oversee study maintenance and regulatory compliance, including REB amendments and renewals, regulatory file updates (e.g., consent revisions, staff changes, CRA/CRO transitions), contract and budget amendments, and preparation for sponsor monitoring visits.

·       Recruit, screen, and consent pediatric participants and families in accordance with ethical, regulatory, and ICH-GCP standards.

·       Review medical records to identify relevant study data points, perform data entry, maintain up-to-date study records, and perform data cleaning tasks to ensure accuracy and completeness.

·       Assume responsibility for maintaining organized, detailed, and accessible study records and ensuring confidentiality of study files and participant records.

·       Assist with data extraction to provide summary reports of project milestones and provide support for the analysis of relevant study outcomes. 

·       Coordinate and conduct complex study visits, ensuring accurate data collection, entry into electronic data capture systems, query resolution, protocol adherence, and timely adverse event reporting.

·       Organize procurement, processing, and shipment of biologic specimens and coordinate required clinical testing with relevant hospital departments.

·       Facilitate data and sample transfers between participating centres for multi-site trials.

·       Participate in audits, site visits, monitoring, and inspections conducted by SickKids, industry sponsors, and regulatory authorities.

·       Assist with tasks related to the studies, including administrative responsibilities such as coordinating meetings and taking minutes, as well as the development of participant-facing materials such as newsletters.

·       Actively contribute to the success of assigned projects by working collaboratively with team members to identify opportunities for improvement, troubleshoot challenges, and implement practical solutions.

·       Foster collaborative relationships with internal departments, sponsors, CROs, government agencies, and community partners to support successful study execution and program growth.

Here's What You'll Need

·       Bachelor of Science Degree (B.Sc.) is a requirement.

·       Master of Science (MSc) or certification in clinical research would be a strong asset (SOCRA or ACRP).

·       Keen interest and/or knowledge of genetics and self-motivation to learn new concepts.

·       2-3 years of experience coordinating clinical research studies (including study visits) is required.

·       Research Ethics training: TCPS2: Core, ICH Good Clinical Practice (GCP), N2SOP v9.0, and Health Canada Division 5 is required.

·       Experience with industry sponsored clinical trials would be an asset.

·       Experience obtaining informed consent and enrolling participants into research studies.

·       Experience using electronic data collection platforms, such as iMedidata, ClinTrak, and REDCap.

·       High proficiency with computer skills and/or the ability to learn new computer programs with ability to effectively use Office365 and the Microsoft Office suite of applications such as SharePoint, Outlook, Microsoft Word, Excel, PowerPoint, Teams. 

·       Professionalism, integrity, and strong work ethic with the proven ability to work independently and collaboratively on tasks.

·       A proven track-record of engaging with a variety of stakeholders in a professional, inclusive, and culturally sensitive manner. 

·       Strong interpersonal skills with excellent written and oral communication skills.

·       Proven ability to work resourcefully and prioritize tasks to effectively balance competing demands from multiple concurrent projects.

·       Desire to learn to use new tools to develop strategies to effectively respond to emerging needs.

·       Effective and proactive problem-solving and critical thinking skills, with the ability to take on varied responsibilities and adapt to evolving priorities.

·       Superior organizational, time management skills, and attention to detail are essential.

·       A commitment to understanding and aiding in the pursuit of equity, diversity and inclusion objectives.
 

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:

·       1 year contract; Hybrid; 1.0 FTE (35 hours/ week)

#LI-DNI

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

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.

Every application is reviewed by a human recruiter and all hiring decisions are made by people. In some cases, AI-assisted tools are used to help review applications based on job-related qualifications.

All positions posted on the SickKids Hospital's Careers Site represent current vacancies, unless otherwise posted in the job description.