Clin. Res. Project Coord.-ri

3 weeks ago

Toronto, Canada SickKids Full time

**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 Coordinator coordinates our clinical research studies according to regulatory and institutional guidelines and requirements. This includes coordinating patient recruitment and data collection, study administration, preparing consents and paperwork required by the Research Ethics Board, and organizing data entry and analysis. The CRPC also assists in the preparation of study results, including presentations, progress reports, and manuscripts and fulfills Clinical Research Assistant responsibilities.

**Here’s What You’ll Get To Do**:

- Participate in the screening and recruitment of patients into clinical studies.
- Interact with patients and families to collect study data.
- Keep abreast of regulations and policies governing clinical research.
- Encourage and foster collaborative relationships with healthcare team at SickKids, other participating centres and government and community agencies.
- Attend relevant departmental meetings or rounds to increase knowledge and understanding.
- May co-supervise (with PI) Clinical Research Assistants, trainees, volunteers.
- Assist in training/orientation of research students.
- Maintain budget records.

**Research Project Development**:

- Read and have a general knowledge of protocol and study measures.
- Assist in design of case-report forms and/or questionnaires.
- Assist PI with scientific and ethical review processes.
- Develop informed consent documents based on regulations, REB consent templates and institutional requirements. Submit to REB and coordinate revisions. Assist PI with annual approval process and amend protocols and consents as required.

**Research Project Operationalization**:

- Develop and monitor timelines for study.
- Assist with database design, in conjunction with PI. Ensure the quality of the database and supervise database cleaning. Perform/assist with data entry and analysis, including planning.
- Assist with design/development of promotional materials/newsletters.
- Organize materials to facilitate protocol adherence, including study binders and checklists of eligibility.
- Develop and maintain study binders for study team use that will include original consent, patient protocol documentation, general correspondence, and case report forms.
- Consult with Pharmacy regarding medication or placebo development and dispensing.
- Participate in audits, site visits and monitoring by SickKids and other regulatory bodies or industry sponsors.
- Screen, provide information and documentation for potential protocol patients (consents, patient eligibility items, required pre-study testing, roadmaps).
- Confirm eligibility of patient (confirm criteria for eligibility satisfied, signed consent available) and register patients.
- Approach eligible patients and families to inform about the study and request consent/assent.
- Organize the procurement of biologic specimens, tests from relevant SickKids departments (DPLM, Diagnostic Imaging, Health Records, etc.). Follow-up on reports.
- Perform health record reviews, patient interviews, assessments as required by study protocols.
- Monitor serious adverse events or reactions, and report immediately to Principal Investigator. Follow-up on adverse events according to SickKids' Policy. This includes filing reports with internal (REB), and external regulatory bodies' notification of collaborators, and/or patients.
- Provide feedback to patients/healthcare team and coordinate clinical follow-up as required. May include writing in the health record.

**Research Project Finalization**:

- Contribute to preparation of reports, presentations, and manuscripts.

**Here’s What You’ll Need**:
**Education**:

- Bachelor of Science with a sound knowledge of medical terminology.
- Certification as a clinical research associate (e.g., SOCRA, ACRP accreditation) is an asset.

**Experience/Skills**:

- Minimum of 2 years of clinical research experience.
- Track record of building and maintaining good working

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