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.

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.

The Clinical Research Coordinator works within the framework of the University of Calgary & Cumming School of Medicine Policies and Procedures, as well as within the Department of Clinical Neurosciences Clinical Research Operating Standards. Workdays may vary in length and may also include weekend hours and national and international travel for meetings and conferences on occasion.

Under the direction of the Director and Principal Investigator (PI), the Clinical Research Coordinator utilizes knowledge of research methods in the planning and implementation of clinical research trials of patients with neuromuscular diseases.

The Clinical Research Coordinator can be a stressful role at times with the responsibility to coordinate multiple protocols of various complexities while juggling constant scheduling conflicts and ever-changing priorities.. This position requires the ability to be resourceful, innovative at problem solving, and comfortable making judgment calls within established guidelines and the regulatory framework.

Summary of Key Responsibilities (job functions include but are not limited to):

PATIENT MANAGEMENT:

• Assist PI's with the delivery of competent, comprehensive, and coordinated care of patients in the neuromuscular clinical research trials
• Assist PI's with the 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
• Assist PI's with the education of the patients and their families on the investigational compound, inclusive of administration, dosing regimen, potential side effects, pharmacodynamics, pharmacokinetics and compliance
• Assist with the delivery of protocol-related assessments and evaluations to achieve all trial-related outcomes in a safe, effective and timely manner;
• Assist PI's with the promotion of compliance through continuous education, support, and monitoring of trial patients
• Utilization of general knowledge and skill in history and physical assessment, as appropriate
• Coordination of follow-up action of all patients discharged early from the clinical trial to ensure continuity of care of patients
• Maintenance of accurate and complete patient clinical care documentation

ADMINISTRATION/ACCOUNTING:

• Maintains a superior understanding of the University with regard to organizational structures, policies, processes, and systems
• Responsible for processing patient expense reports (mileage, taxi, airfare)
• Process AHS and UofC invoices (pharmacy, cardiology, Alberta Precision Labs)
• Assist with the set up of Industry Sponsors for invoicing with UCalgary Finance where appropriate, or OnCore
• Receive Invoices, monitor and reconcile patient visits in EDC (Electronic Data Capture system)/Investigator Site File and process expense reports from sub-sites with Investigator Initiated studies
• Process purchasing, travel & expense reports for all Neuromuscular Research Group staff
• Maintain financial reconciliation for each project in a timely manner

CLINICAL TRIALS:

• Assist the Director and Principal Investigator in the planning and implementation of Investigator-initiated and Sponsor-initiated clinical trial protocols
• 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, personnel changes, protocol deviations and study closure and publications
• Completion and submission of all regulatory requirements for the clinical trial protocols
• Contribute to a collaborative multi-disciplinary team environment to build support and awareness of clinical trial protocols
• Provide input to source documents to capture relevant data outcomes and manage overall data
• Maintain Informed Consent Forms

Qualifications / Requirements:

• Minimum Bachelor Degree level education in an applicable field (e.g. Science, or other related degree considered. Nurse Practitioners and Physiotherapists with Clinical Trial experience are welcome to apply). Graduates of a Health Professional program or an equivalent Masters level education will be considered
• Certification or evidence of attendance in professional development opportunities in the area of clinical neurosciences and neuromuscular diseases considered a strong asset
• Active membership in Society of Clinical Research Associates (SOCRA) preferred
• Previous experience in the area of clinical neurosciences, and neuromuscular diseases is strongly preferred
• Experience in clinical research methodologies required
• Minimum 1-2 years clinical trial research experience in drug studies is preferred
• Ability to function independently and within a team environment
• Strong communication and interpersonal skills required
• Strong organizational and time management skills required
• Effective ability to adapt to change and shifting priorities
• Technical dexterity, knowledge and skill working with computer technology required
• Excellent attention to details a must
• A vehicle will be required as there will be a need to travel between the Foothills Medical Campus and South Health Campus