Clinical Research Project Coordinator - RI

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.

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 Facilities and Services, 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 may also fulfill Clinical Research Assistant responsibilities and activities. The CRPC will report to the Senior Manager, Clinical Research Facilities and Services.

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.

Here's What You¿ll Get to Do

• 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, monitoring and site visits by SickKids Regulatory Compliance Office, 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.

Here¿s What You¿ll Need.

Essentials

• A bachelor¿s degree in a Health Science related field, ideally with a post-graduate diploma in clinical research and two years¿ experience in clinical research, or a master¿s degree in a Health Sciences related field, with two years¿ clinical research experience.
• A strong knowledge of regulations and policies governing clinical research (e.g., Tri-council Policy Statement, ICH Guidelines, Good Clinical Practices, Health Canada and FDA regulations).
• The CRPC must have the ability to read and understand clinical protocols, study procedures and scientific literature and have enthusiasm to keep abreast of current regulations and policies governing clinical research.
• Demonstrated commitment and actions in advancing equity, diversity, and inclusion objectives.

Asset

• Certification by the Society of Clinical Research Associates (SOCRA) as a Certified Clinical Research Professional (CCRP).
• Prior experience at SickKids performing the activities of a Clinical Research Assistant and/or Coordinator.

Here¿s What You¿ll Love

Benefits

• This position is eligible for employee benefits coverage; including but not limited to, health and dental benefits. The benefits offered will be discussed at the time of position offer.
• A focus on employee wellness with our new Staff Health and Well-being Strategy. Self-care helps us support others.

Impact

• 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:

• Full-time temporary (35 hours/ week).
• Two-year contract with possibility of renewal.
• Hybrid Work Model.

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.

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.

Technical difficulties? Email [email protected] 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.