The Clinical Research Project Coordinator coordinates 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 assist in the preparation of study results, including presentations, progress reports, and manuscripts.
Here's What You'll Get To Do:
Protocol Related:
- May assist Principal Investigators (PIs) in new research proposals and preparation of grant applications; Contribute to preparation of reports, presentations, and manuscripts.
- Read and have a general knowledge of protocol and study measures.
- Assist in design of case-report forms and/or questionnaire
- Assist PIs 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's with annual approval process and amend protocols and consents as required.
- Develop study binders for clinical department and study team use.
- Encourage and foster collaborative relationships with 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, in conjunction with Principal Investigator(s) and Database Analyst. 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.
Research Subject Related:
- Develop and monitor timelines for study.
- 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.
- 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 SickKids departments (DPLM), Diagnostic Imaging, Health Records, etc.). Follow-up on reports.
- 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.
- Perform patient interviews, assessments as required by study protocols.
- Maintain research equipment.
- Provide feedback to patients/healthcare team and arrange clinical follow-up as required. May include writing clinical reports.
- Organize materials to facilitate protocol adherence, including study binders and checklists of eligibility.
- Consult with Pharmacy regarding medication or placebo development and dispensing.
- In some studies, you may organize patient care as well.
Human Resources / Financial:
- Co-supervise (with PIs) Clinical Research Assistants, trainees, volunteers, order supplies.
- Assist in training/orientation of new research staff.
- Prepare/Submit purchase requisitions, invoices, etc.
- Maintain budget records.
Here's What You'll Need:
- A Master's degree in Epidemiology, Health Science or a related field with a minimum of three years' experience in clinical research or a post-secondary degree in a health-related discipline (e.g., Nursing, Epidemiology, Health Sciences, Psychology) with 2 years related clinical research experience.
- A clinical professional degree may be an asset, as would certification as a clinical research associate (e.g., SOCRA, ACRP accreditation).
- Function independently yet collaboratively within a team.
- Effective communication, interpersonal, facilitation and organizational skills.
- Excellent time management skills to properly support multiple PI's equally and will have to be able to coordinate several projects simultaneously.
- A commitment to understanding and aiding in the pursuit of equity, diversity and inclusion objectives
Employment Type: Contract Position, 1 year, 35 hours, Flexible Work Schedule
#LI-DNI
