Reporting to the Department of Psychiatry Research Program Manager and Principal Investigators (PI), the Clinical Research Coordinator will be responsible for the recruiting and screening of potential study participants for clinical research protocols; liaising with local community and service network to enhance recruitment; overseeing study-related activities and training/qualifications of the PI, current and new back-up physicians; training and supervising of new research staff; maintaining compliance with regulatory, ethics and other stipulations as necessary; administrating health care services and building and maintaining a network of contacts internally and externally to help promote research at the Department of Psychiatry Research Program at Queen’s University. Experience in clinical trials research is highly preferred although those with related research experience may be considered.

KEY RESPONSIBILITIES:
• Assists multiple PIs in the initiation and implementation of study protocols
• Provides leadership in the conduct of clinical trials. Works closely with the PI and back-up physicians during screening and follow-up visits.
• Ensures the site is compliant in conducting clinical trial related activities
• Organizes PI start-up meetings and study site initiation meetings
• Trains and supervises new research staff
• Assists with the recruitment, screening, and the enrolment of potential study participants, including obtaining informed consent and assent
• Schedules participant/parent, physician/clinician and vendor visits (i.e. LifeLabs) and perform covid-19 screenings and study visits
• Plans the visits in accordance with the physician’s availability and other research members
• Leads the research team with study related visit procedures/activities and proper source documentation
• Alerts research pharmacist/staff and Ongwanada reception of upcoming visits
• Obtains IP prescription from the physician in time for the research pharmacist and upcoming study visit
• Foresees and ensures coverage from back-up physicians when PI unavailable or absent
• Provides patient education and counseling regarding protocol requirements, study treatment schedules, the use of data collection tools and follow-up visits
• Administers study medications; collects blood, urine and other samples as required; packs and ships samples, and collects clinical data from patients directly
• Ensures that study patients are efficiently monitored and that safety requirements are implemented as necessary; accurately and promptly reports Serious Adverse Events as dictated by the protocol
• Arranges and provides compensation and expense reimbursements for participants
• Maintains supply, gift card expense receipts and vendor related payments
• Participates in study-related meetings such as site evaluations, site initiations, close-out visits, investigator meetings, monitoring-visits, and study-conference calls
• Adheres to Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and other applicable regulatory requirements
• Develops and reviews on an ongoing basis standard operating procedures, source documents, study documentation, third-party vendor subcontracts, and study processes. Ensures that all documents and practices comply with International Conference of Harmonisation (ICH), Good Clinical Practice guidelines, Health Canada, Food and Drug Administration (FDA), Tri-Council Policy Statement, and Research Ethics Board regulations
• Works directly with participants, families, pharmacy and staff for the study visits
• Performs study related tasks i.e. EEG, Brain Gauge, vital signs, etc.
• Coordinates research reliable assessments, per the protocol i.e. parent interviews, IQ tests, etc.
• Participates in the scoring of assessments
• Performs data entry and query response
• Prepares Human Research Ethics Board submissions (TRAQ DSS and CTO) including annual renewals and amendments, informed consents/assent forms and maintains trial related documents
• Maintains project files including ethics committee approvals and renewals, investigator CVs and physician/clinician licenses CAPAs, secondary deviation logs, correspondence, clinical investigators brochure, protocols, manual of operations,pharmacy manual, , consent/assent documents and worksheets, source documents, clinical trial material shipping orders, logs, , meeting agendas and minutes, data transfer agreements, letter of agreements and all other documentation as required
• Coordinates general office duties (e.g. filing, faxing, mailing, photocopying)
• Interacts and coordinates with various departments (i.e. laboratory, pharmacy, medical records, clinics, hospitals etc.) to facilitate study-related activities and study visits
• Manages multiple studies in various stages of implementation
• Performs study-related assessments as required per protocol and ensures that all documentation is accurate and ongoing
• Monitors and maintain equipment calibration with vendors
• Undertakes other duties as required