Clinical Research Project Coordinator, Tuberous Sclerosis Complex Program

at  SickKids

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CLINICAL RESEARCH PROJECT COORDINATOR - TUBEROUS SCLEROSIS COMPLEX PROGRAM

The Comprehensive Epilepsy Program within the Division of Neurology is seeking a Clinical Research Project Coordinator (CRPC) to coordinate clinical research studies on Tuberous Sclerosis Complex, a genetic condition that results in benign tumors affecting multiple organ systems. The CRPC will work on a variety of industry-sponsored clinical trials, research registry, and other ongoing clinical research studies (mainly observational non-interventional studies). The CRPC will coordinate studies according to regulatory and institutional guidelines and requirements. This includes coordinating patient recruitment, data collection, data entry and analysis, study administration, preparing consents and paperwork required by the Research Ethics Board (REB) and organizing data entry and analysis. The CRPC also will assist in the preparation of study results, including presentations, progress reports, and manuscripts.

• Assist the Principal Investigator (PI) in new research proposals, preparation of grant applications and scientific review process; conduct literature reviews and keep current with study literature; contribute to preparations of reports, presentations, and manuscripts.
• Initiate study set-up and obtain and maintain research ethics approval and research ethics amendments; Read and have a general knowledge of protocol and study measures; keep abreast of regulations and policies governing clinical research. Develop study binders for clinical department and study team use. Organize materials to facilitate protocol adherence, including study binders and checklists of eligibility.
• 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, consents, and case report forms as required.
• Provide information and documentation for potential study participants (consents, patient eligibility items, required pre-study testing and roadmaps). Confirm eligibility of participants and subsequent registration in studies.
• Participate in study recruitment, consenting, participant follow-up and data collection. Perform participant interviews and assessments as required by study protocols. Provide feedback to patients/healthcare team and arrange clinical follow-up as required.
• 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 and tests from relevant departments. Consult with Pharmacy regarding medication or placebo development and dispensing.
• Assist with database design, including case report forms and/or questionnaires. Ensure the quality of the database and supervise database cleaning. Perform/assist with data entry and analysis including planning.
• 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.
• Participate in audits, site visits and monitoring by SickKids and other regulatory bodies or industry sponsors. Develop and monitor timelines for studies. Participate in or give in-services on study requirements. Prepare/submit purchase requisitions and invoices; maintain budget records.
• Encourage and foster collaborative relationships with the healthcare team at SickKids, other participating centres and government and community agencies. Attend relevant departmental meetings or rounds in order to increase knowledge and understanding. Assist with design/development of promotional materials/newsletters.
• Co-supervise (with PI) Clinical Research Assistants, trainees, volunteers; assist in training/orientation of new research staff.