Clinical Research Coordinator, Clinical Neurosciences

Overview

The Department of Clinical Neurosciences in the Cumming School of Medicine invites applications for a Clinical Research Coordinator. This Full-time Fixed Term position is for approximately 6 months (based on length of grant funding), with the possibility of extension. The Clinical Research Coordinator demonstrates a broad level of knowledge and skill in delivering competent, comprehensive and coordinated care, education, and counseling to patients and their families involved in clinical research trials within the Department of Clinical Neurosciences.

This position assists with securing necessary technical services needed to conduct clinical trials. Under the direction of the Principal Investigator and Research Manager, the Clinical Research Coordinator utilizes knowledge of research methods in the development, planning and implementation of clinical research trials for patients with neuromuscular diseases. Responsibilities include protocol development, facilitation of CHREB requirements for approval, coordination and planning of protocol-related assessments and evaluations, patient accrual, ongoing communication with the Ethics Board, Sponsor, Investigators, service providers and other healthcare disciplines.

The Coordinator manages multiple protocols of varying complexity within established time frames and serves as an advocate for research and development of new and advanced treatments for patients with neuromuscular diseases.

We are a global leader in Neuromuscular Research with outstanding team dynamics and a strong track record in Clinical Trials, sponsor audits and regulatory inspections.

The role is demanding, with responsibilities for managing multiple protocols, scheduling, and adapting to changing priorities. The Coordinator should be resourceful, innovative in problem solving, and capable of making judgments within established guidelines. The role supports research and development of new and advanced treatments for patients with neuropathic pain and neuromuscular diseases.

(job functions include but are not limited to)

• Delivery of competent, comprehensive, and coordinated care of patients in neuromuscular clinical research trials
• Incorporation of care standards (assessment, planning, implementation and evaluation) to promote quality of care for trial participants and their families
• Education of patients and their families on all aspects of the clinical trials and disease process to achieve informed participants throughout the duration of trials
• Protection of subjects and subject rights according to ICH, Declaration of Helsinki, Tri-Council Policy Statement and CHREB requirements
• Education of patients and their families on the investigational compound, including administration, dosing, potential side effects, pharmacodynamics, pharmacokinetics and compliance
• Promotion of compliance through continuous education, support, and monitoring of trial patients
• Utilization of advanced knowledge in history and physical assessment, as appropriate
• Clinical judgment in assessment, treatment and discharge from research protocols, including determining medical suitability for trials and anticipating patient needs
• Coordination of follow-up for patients discharged early from trials to ensure continuity of care
• Maintenance of accurate and complete patient clinical care documentation

• Track 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
• Develop and maintain understanding of University policies, processes, and systems
• Process patient expense reports (mileage, taxi, airfare)
• Process AHS and UofC invoices (pharmacology, cardiology, Calgary Lab Services, CHREB)
• Set up Industry Sponsors for invoicing with Research Accounting
• Receive invoices, track and reconcile patient visits in EDC and process expense reports from sub-sites with Investigator Initiated studies

• Collaborate with the Principal Investigator in developing, planning and implementing Investigator-initiated and Sponsor-initiated clinical trial protocols
• Assess human resource capacity, facility, equipment, space, service provider, and timeline requirements for trial implementation
• Train and guide staff and students in applicable aspects of trial protocols
• Assess budget parameters and negotiate budgets for trial protocols
• Provide ongoing clinical trial account management as delegated
• Prepare and submit all documentation for protocol approval to CHREB, including informed consent forms, advertisements, protocols, amendments, Investigator brochures and related documents
• Maintain ongoing communication with CHREB regarding renewals, serious adverse events, safety reports, amendments, and study closure
• Coordinate legal contacts for clinical trials
• Complete and submit all regulatory requirements for trial protocols
• Engage in a collaborative…