Clinical Research Project Assistant Next Job Apply for Job Job ID 22856 Location Toronto, Ontario Annualized Hiring Range $55,510 - $76,318 *Compensation commensurate with experience Dept/Program Name CRC- Hospital Research Unit Target Openings 1 Work Type Hybrid Hours of Work 35.00 FTE 1.00 Contract Length 2 years Level of Police Check Criminal & Judicial Record Date Posted 2025-07-24 Deadline to Apply 2025-08-04 Add to My Favorite Jobs Email this Job **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** The Clinical Research Project Assistant (CRPA) 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 CRPA will report to the Senior Manager, Clinical Research Facilities and Services and assist Clinical Research Project Coordinators in daily activities. The CRPA will work closely with study Clinical Coordinators, Program Managers, Clinicians, SickKids Clinical Research Centre (CRC) Nurses, SickKids Central Biobank Research Technologists, SickKids clinical research teams and affiliated institutes, organizations, and collaborative networks. The successful candidate will have the opportunity to contribute to research into new therapeutic agents for rare pediatric diseases including n of 1 clinical trials, viral and nucleic acid-based gene therapies, immunotherapies, and other exciting treatments. **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 study 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 CRPA will develop and submit applications and amendments to the REB and sponsors and respond to queries. · Develop and maintain study documentation including electronic records and study binder management. · Review charts and participant data and enter in sponsor 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, source data verification, analysis, cleaning and database locks. · Provide information and documentation for potential study participants (consents, participant eligibility items, review of EPIC medical records and charts). · Confirm eligibility of participants and register participants (i.e. confirm eligibility criteria are satisfied, signed consent available). · Initiate internal service (medical) requests via EPIC and/or other service platforms. · Organize and coordinate participant study visits including pharmacy pickups, collection of biologic specimens, test requisitions/orders, and reports for relevant SickKids departments including SickKids Clinical Research Centre, Department of Paediatric Laboratory Medicine (DPLM), Diagnostic Imaging, EEG, etcetera and transport of materials to SickKids Central Biobank and/or central laboratories. · Under guidance from study investigators, report serious adverse events or drug reactions, surveil for laboratory range exceptions and other reportable events. Follow-up on adverse events, including filing reports with internal (REB) and external regulatory agencies. · Participate and prepare for internal audits by SickKids Regulatory Compliance Office, sponsor monitors, and other regulatory agencies. · Conduct consent processes, screening and participant interviews as required by study protocols. · Draft Standard Operating Procedures (SOPs), Work Instructions and organize materials to facilitate protocol adherence, including study binders and checklists of eligibility. · Maintain and monitor study timelines and budgets. **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. · 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, Network-of-Networks (N2)). · The CRPA must have the ability to read and understand clinical protocols, investigator brochures and other study procedures and keep abreast of current regulations and policies governing clinical research. Asset · Certification by the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP) or Regulatory Affairs Professional Society (RAPS). · Prior experience at SickKids or other pediatrics-focused research hospital, performing the activities of a Clinical Research Assistant or similar role · Experience with EPIC, study EDCs, adverse event reporting, ethics submissions, assisting with investigator-initiated and sponsored trials, drafting SOPs, conducting consent sessions **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 (https://www.sickkids.ca/en/careers-volunteer/careers/) . **Employment Type** : · Full-time temporary (35 hours/ week). · Two-year contract with possibility of renewal. · Hybrid work model **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. (https://www.sickkids.ca/en/about/edi/workplace-inclusion/) **Accessibility & Accommodation** If you require accommodation during the application process, please reach out to our aSKHR team (ask.hr@sickkids.ca) . 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.