Clin. Res. Project Coord.-ri

2 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**:
**Clinical Research Project Coordinator**

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

**Here’s What You’ll Get To Do**
- Initiate study set-up, and obtain and maintain research ethics approval and research ethics amendments
- Participate in study recruitment, consenting, participant follow-up and data collection
- Oversee and participate in data management (e.g., data cleaning and data entry) and quantitative/qualitative data analysis
- Read and have a general knowledge of protocol and study measures
- Assist in design of case report forms and/or questionnaires
- Assist PI with science review process
- Keep abreast of regulations and policies governing clinical research
- 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 protocol and consents as required
- Develop study binders for clinical department and study team use
- Encourage and foster collaborative relationships with the healthcare team at SickKids, other participating centres and government and community agencies
- Participate in audits, site visits and monitoring by SickKids and other regulatory bodies or industry sponsors
- Conduct literature reviews and keep current with study literature
- Assist with database design. Ensure the quality of the database and supervise database cleaning. Perform/assist with data entry and analysis including planning
- Participate or give in-services on study requirements
- Attend relevant departmental meetings or rounds in order to increase knowledge and understanding
- Assist with design/development of promotional materials/newsletters
- Develop and monitor timelines for study
- Provide information and documentation for potential protocol patients (consents, patient eligibility items, required pre-study testing and roadmaps)
- Confirm eligibility of and registering patients
- Initiate and maintain a research chart that will include original consent, patient protocol documentation, general correspondence and case report forms
- Organize the procurement of biologic specimens, tests from relevant departments
- Monitor serious adverse events or reactions and report immediately to PI. Following-up on adverse events including filing reports with internal and external regulatory bodies, notification of collaborators and/or patients
- Perform patient interviews and assessments as required by study protocols
- Maintain research equipment
- Provide feedback to patients/healthcare team and arrange clinical follow-up as required
- Organize materials to facilitate protocol adherence, including study binders and checklists of eligibility
- Consult with Pharmacy regarding medication or placebo development and dispensing
- Co-supervise (with PI) Clinical Research Assistants, trainees, volunteers
- Assist in training/orientation of new research staff
- Prepare/submit purchase requisitions and invoices
- Maintain budget records

**Here’s What You’ll Need**
- Master’s degree in a Health Science discipline
- Certification as a clinical research associate (e.g., SoCRA, ACRP accreditation) is an asset
- 1-2 years related clinical research experience
- Familiarity with both quantitative and qualitative research methodology including interviews and analyzing quantitative and qualitative data
- Previous experience working with quantitative (e.g., SAS, R) and qualitative (e.g., NVivo) software is an asset
- Previous experience with online databa

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