Clinical Research Coordinator, Clinical

2 weeks ago

Calgary, Canada The University of Calgary Full time

**Position Overview**

This position reports to the Director, Health Innovation Lab.

The Clinical Research Coordinator demonstrates a vast 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. Further, this position is responsible for assisting with securing necessary technical services needed to conduct clinical trials.

We are a global leader in Neuromuscular Research having outstanding team dynamics, and achieving excellence. Our great expertise in Clinical Trials results in modeling requests from Clinical Research Organization personnel, and positive sponsor audits/regulatory inspection experiences.

The Clinical Research Coordinator is a stressful role with the responsibility to manage multiple protocols of various complexities while juggling constant scheduling conflicts and ever-changing priorities. This position serves as role-model in the research and development of new and advanced treatments for patients with neuropathic pain and neuromuscular diseases. This position requires the ability to be resourceful, innovative at problem solving, and comfortable making judgment calls within established guidelines.

The position is required to work a seven hour day Monday through Friday with one hour for lunch. 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.

**Position Description**

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

- 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;
- Education of the patients and their families on the investigational compound, inclusive of administration, dosing regimen, potential side effects, pharmacodynamics, pharmacokinetics and compliance;
- Delivery of all protocol-related assessments and evaluations to achieve all trial-related outcomes in a safe, effective and timely manner;
- Promotion of compliance through continuous education, support, and monitoring of trial patients;
- ADMINISTRATION/ACCOUNTING:

- 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
- Responsible for processing 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 (Electronic Data Capture system) and process expense reports from sub-sites with Investigator Initiated studies
- CLINICAL TRIAL MANAGEMENT:

- Collaboration and consultation with the 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 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 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

**Qualifications / Requirements**:

- Minimum MSc level education in an applicable field (e.g. Science, or other related degree considered). Graduate of a Health Professional program or an equivalent Masters level education will be considere

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