Clinical Research

Description The Department of Clinical Neurosciences the Cumming School of Medicine invites applications for a Clinical Research Coordinator . This Full-time Fixed Term position is for approximately 6months (based on length of grant funding), with the possibility of extension. Under the direction of the Executive Director and Principal Investigator, the Clinical Research Coordinator utilizes knowledge of research methods in the detailed development, planning and implementation of clinical research trials of patients with neuromuscular diseases. We are a global leader in Neuromuscular Research having outstanding team dynamics, and are a Centre of Excellence. Our operational expertise in Clinical Trials results in modeling requests from trial groups both within and external to the University of Calgary and Clinical Research Organization personnel for site optimization, and results in positive sponsor audits/regulatory inspection experiences. Work days may vary in length and may also include weekend hours and national and international travel for meetings and conferences on occasion.
A vehicle will be required as there will be a need to travel between the Foothills Campus and South Health Campus. Patient Management Delivery of competent, comprehensive, and coordinated care of patients in the neuromuscular clinical research trials Incorporation of care standards (assessment, planning, implementation and evaluation) to promote quality of care to patients participating in the clinical trials, and their families Education of patients and their families on all aspects of the clinical trials and associated disease process so as to achieve fully informed participants throughout duration of clinical trials Protection of subjects and subjects rights according to the International Conference on Harmonization (ICH), Declaration of Helsinki guidelines, the Tri-Council Policy Statement and through Conjoint Health Research Ethics Board (CHREB) requirements Promotion of compliance through continuous education, support, and monitoring of trial patients Utilization of clinical judgment in the assessment, treatment and discharge of patients from the research protocols. Examples include independent judgment on whether patients are medically suitable for a clinical trial and anticipating patient needs during the trial Coordination of follow-up action of all patients discharged early from the clinical trial to ensure continuity of care of patients Keep track of sub-site invoices, submit expense reports, and issue payments to study sites for Investigator Initiated studies Create and issue invoices, track payments and issue travel payments for Industry Studies Develops and maintains a superior understanding of the University with regard to organizational structures, policies, processes, and systems Process AHS and UofC invoices (pharmacy, cardiology, Alberta Precision Labs) Receive Invoices, track and reconcile patient visits in EDC (Electronic Data Capture system)/Investigator Site File and process expense reports from sub-sites with Investigator Initiated studies Manage invoicing and payments for all projects Keep track of research expense invoices and issue payments to study sub-sites, as well as perform maintenance tasks related to operating grants as required by research accounting Process purchasing, travel & expense reports for all Neuromuscular Research Group staff Clinical Trial Management Collaboration and consultation with the Executive Director and Principal Investigator in the development, planning and implementation of Investigator-initiated and Sponsor-initiated clinical trial protocols Assessment of appropriate human resource capacity, facility, equipment, space, service provider, and timeline requirements to consider study feasibility and implement clinical trial protocols and organization of same Training and guidance of staff and students in the organization and delivery of applicable aspects of clinical trial protocols Assessment of appropriate budget parameters and budget negotiation for clinical trial protocols Ongoing clinical trial account management as delegated Preparation and submission of all appropriate documentation for protocol approval to the Conjoint Health Research Ethics Board, inclusive of informed consent forms, advertisements (e.g. ensure advertisement meets CHREB regulations), protocols, protocol summaries/clarifications and amendments, Investigator brochures and completed protocol submission of new protocol forms, patient education tools, questionnaires, emergency identification cards, Health Canada No Objection Letters and applicable Investigator curriculum vitaes and all essential documents Maintenance of ongoing communication with the Conjoint Health Research Ethics Board regarding aspects inclusive of annual renewal, serious adverse events, safety reports, protocol amendments, informed consent modifications and/or amendments, perso