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 6 months (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.
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
- 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
- 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
- Utilization of advanced knowledge and skill in history and physical assessment, as appropriate
- 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
- 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 (pharmacy, cardiology, Alberta Precision Labs)
- Set up Industry Sponsors for invoicing with UCalgary Finance where appropriate, or OnCore
- 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, personnel changes, protocol deviations and study closure and publications
- Coordination and processing of legal contacts for clinical trials
- Completion and submission of all regulatory requirements for the clinical trial protocols
- Engagement in a collaborative multi-disciplinary team environment to build support and awareness of clinical trial protocols
- Development of source documents to capture relevant data outcomes and manage overall data
- Collaboration in the development of research databases
- Development of Informed Consent Forms
- Development and ongoing monitoring of recruitment strategies
- Recruitment and enrolment of appropriate protocol participants
Qualifications / Requirements:
- Minimum MSc 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 an asset
- Active membership in Society of Clinical Research Associates (SOCRA) preferred
- Previous experience in the area of clinical neurosciences, and neuromuscular diseases preferred
- Strong experience in clinical research methodologies required
- Minimum 3 years clinical trial research experience in drug studies is preferred
- Demonstrated ability to function independently and within a team environment
- Strong leadership, communication and interpersonal skills required
- Demonstrated strong organizational and time management skills required
- Effective ability to adapt to change and shifting priorities
- Demonstrated 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 Campus and South Health Campus
- Exceptional interpersonal skills, demonstrating professionalism, discretion, courtesy, compassion and respect in all interactions with internal and external clients
- Excellent writing skills
Application Deadline: July 14, 2025
We would like to thank all applicants in advance for submitting their resumes. Please note, only those candidates chosen to continue on through the selection process will be contacted.
This position is part of the AUPE bargaining unit, and falls under the Technical Job Family, Phase 2.
For a listing of all management and staff opportunities at the University of Calgary, view our Management and Staff Careers website.
About the University of Calgary
UCalgary is Canada's entrepreneurial university, located in Canada's most enterprising city. It is a top research university and one of the highest-ranked universities of its age. Founded in 1966, its 36,000 students experience an innovative learning environment, made rich by research, hands-on experiences and entrepreneurial thinking. It is Canada's leader in the creation of start-ups. Start something today at the University of Calgary. For more information, visit ucalgary.ca.
The University of Calgary has launched an institution-wide Indigenous Strategy committing to creating a rich, vibrant, and culturally competent campus that welcomes and supports Indigenous Peoples, encourages Indigenous community partnerships, is inclusive of Indigenous perspectives in all that we do.
As an equitable and inclusive employer, the University of Calgary recognizes that a diverse staff/faculty benefits and enriches the work, learning and research experiences of the entire campus and greater community. We are committed to removing barriers that have been historically encountered by some people in our society. We strive to recruit individuals who will further enhance our diversity and will support their academic and professional success while they are here. In particular, we encourage members of the designated groups (women, Indigenous peoples, persons with disabilities, members of visible/racialized minorities, and diverse sexual orientation and gender identities) to apply. To ensure a fair and equitable assessment, we offer accommodation at any stage during the recruitment process to applicants with disabilities. Questions regarding [diversity] EDI at UCalgary can be sent to the Office of Institutional Commitments (equity@ucalgary.ca) and requests for accommodations can be sent to Human Resources (hrhire@ucalgary.ca).
Do you have most but not all the qualifications? Research show that women, racialized and visible minorities, and persons with disabilities are less likely to apply for jobs unless they meet every single qualification. At UCalgary we are committed to achieving equitable, diverse, inclusive and accessible employment practices and workplaces and encourage you to apply if you believe you are right for this role.
We encourage all qualified applicants to apply, however preference will be given to Canadian citizens and permanent residents of Canada.
