Clinical Research Coordinator, Clinical Neurosciences, Cumming School of Medicine

Position 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 1 year (based on length of grant funding), with the possibility of extension.

The Clinical Research Coordinator demonstrates an exceptional 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.

Under the limited supervision of the Principal Investigator, and the in-scope supervisor (Senior Clinical Research Coordinator) the Clinical Research Coordinator independently utilizes extensive knowledge of research methods and clinical trial design and deployment in the detailed development, planning and implementation of clinical research trials of patients with neuropathic pain and neuromuscular diseases. 

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:
  • Independent delivery of competent, comprehensive, and coordinated care of patients in the neuropathic pain and neuromuscular clinical research trials
  • Must be able to perform technical assessments using equipment for spirometry (breathing), hand held dynamometry, grip strength, overall patient function and strength assessments, suicidality/depression, and timed distance testing (training provided)
  • Able to obtain vitals and perform ECG testing (training provided)
  • 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 and coordination 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 expert 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
  • Maintenance of accurate and complete patient clinical care documentation
  • Communication with primary physician to ensure coordinated patient care
  • Delivery of expert clinical management of patients throughout course of involvement in clinical trials and in accordance with Good Clinical Practice Guidelines and regulatory guidelines
• CLINICAL TRIAL MANAGEMENT:
  • Leads the development, planning and implementation of Investigator-initiated and Sponsor-initiated clinical trial protocols in collaboration and consultation with the Principal Investigator
  • Conducts implementation planning for clinical trial execution including assessment of appropriate human resource capacity, facility, equipment, space, service provider, and timeline requirements to implement clinical trial protocols and organization of same
  • Liaises with internal and external stakeholders such as patient care unit managers, Alberta Health Services care delivery managers, and clinical staff to ensure necessary trial resources including space, equipment, and laboratory services are available for clinical trial execution.  This may include negotiation of fees
  • Direction, mentorship and coaching of staff and students in the organization and delivery of applicable aspects of clinical trial protocols
  • Development of site budget parameters for clinical trial protocols and negotiate budgets with CROs/Sponsors
  • Ongoing clinical trial financial management as delegated; this may include liaising with trial sponsors and University financial administrators to manage the flow of trial financing and supervision of trial expenses for internal and external resources as well as patient expense claims
  • 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
• 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 
  • Manage 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 
  • Maintain financial reconciliation for each project in a timely manner 
  • Highly-developed organizational skills and ability to anticipate needs, plan, organize, coordinate and perform work with little or no direction 

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 considered
• Certification or evidence of regular and ongoing attendance in professional development opportunities in the area of clinical trials, leadership, financial management
• Active membership in Society of Clinical Research Associates (SOCRA) preferred
• 5- 7 years of progressive responsibilities and experience in drugs studies and administration in the area of clinical neurosciences, neuropathic pain and neuromuscular diseases preferred; this includes experience designing and developing protocols and clinical trial implementation
• Extensive and expert knowledge of clinical research methodologies required
• At least 3 years experience supervising and mentoring junior clinical research staff
• Clinical trial leadership experience including internal and external stakeholder consultation
• Clinical trial financial management experience including development of budgets and oversight of trial costs/expenses
• Demonstrated ability to function independently and within a team environment
• Exceptional leadership, communication and interpersonal skills required
• Demonstrated strong organizational and time management skills required
• Effective ability to adapt to change and shifting priorities
• Demonstrated expert technical dexterity, knowledge and skill working with computer technology required
• Demonstrated clinical trial leadership and implementation
• Exceptional interpersonal skills, demonstrating professionalism, discretion, courtesy and respect in all interactions with internal and external clients 
• Excellent writing skills 

Application Deadline: This position will remain open until filled; however, applicants will be reviewed as they are received.

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.

Additional Information

This position is part of the AUPE bargaining unit, and falls under the Technical Job Family, Phase III.

To find out more about management and staff opportunities at the University of Calgary and all we have to offer, view our Management and Staff Careers website. For more information about the Cumming School of Medicine visit Careers in the Cumming School of Medicine.

The University strongly recommends all faculty and staff are fully vaccinated against COVID-19.

About the University of Calgary

The University of Calgary is Canada’s leading next-generation university – a living, growing and youthful institution that embraces change and opportunity with a can-do attitude. Located in the nation’s most enterprising city, the university is making tremendous progress on its Eyes High journey to be recognized as one of Canada’s top five research universities, grounded in innovative learning and teaching and fully integrated with the community it both serves and leads. The University of Calgary inspires and supports discovery, creativity and innovation across all disciplines. For more information, visit ucalgary.ca.

The University of Calgary has launched an institution-wide Indigenous Strategy in line with the foundational goals of Eyes High, 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.

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 professional success while they are here. We encourage all qualified applicants to apply, however preference will be given to Canadian citizens and permanent residents of Canada.