QuiCR Clinical Research Coordinator

This position has an end date of one year from the date of hire and offers a comprehensive benefits package which can be viewed at: www.hrs.ualberta.ca.

Reporting to the Quality Improvement & Clinical Research Alberta Stroke Program (QuICR) Steering Committee, the Clinical Research Coordinator at the University of Alberta will work closely with the Project Manager at the University of Calgary to provide project leadership and management over the QuICR Clinical Research Trials aimed at improvement outcomes for patients experiencing stroke and TIA. QuICR is a $5 million (over 5 years) Alberta Innovates-Health Solutions (AIHS) and Collaborative Research and Innovation Opportunities (CRIO) project that includes: quality improvement/knowledge translation for fast thrombolysis of stroke patients, diagnosis and management of TIA, building a stroke registry, performing various clinical research projects and focusses on trials, operationally in Edmonton, but will have additional provincial focus.

The successful applicant will help provide oversight on all QuICR Research trials being done in the province and helps to work through their successful completion. This means careful coordination with the team at the University of Calgary to ensure smooth  trial operations and practice at both sites. This position requires occasional travel within Alberta.

Duties

• Refines study procedures as required to make research protocols highly-specific and executable (that is, logistics, resources, regulations) at internal and external study sites
• Develops project milestones and timelines and ensure that the project’s key objectives are being met
• Ensures identified project tasks for the QuICR project are completed within identified timelines and that the overall goals of the project are met
• Works closely with the financial manager at the University of Calgary to ensure adherence to the project budget
• Prepares consent forms, ethics submissions and renewals (Human Research Ethics Review Process) and amendments
• Designs and reviews study materials (data collections materials including data collection forms and shadow charts)
• Completes regulatory applications to governing bodies such as Health Canada
• Develops study procedure protocols; communicates study procedures and any changes therein to study assistants and off-site study coordinators
• Manages project communication between various levels of stakeholders (research and operational) including facilitating and coordinating meetings and steering committee, scientific advisory board and community advisory board
• Ensures all aspects of the study are performed within International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice and Tri-Council Policy Statement guidelines
• Trains and monitors study coordinators to implement the research protocols
• Coordinates and monitors ongoing participant lab (and blood) testing
• Troubleshoots for any potential quality assurance issues
• Updates the Project Manager and Steering Committee on the progress of the studies
• Liaises with Alberta Health Services, University departments including the Research Ethic Boards and Industry partners on issues related to study operations
• Liaises with the leads on the clinical stroke registry, imaging stroke registry knowledge translation/quality improvement, education and clinical research
• Supports recruitment of eligible patients in the project through creation of recruitment process (documentation, etc.)
• Gathers and organizes regulatory documents from all study sites (internal and external) participating in QuICR studies
• Ensures external sites receive adequate and necessary training to conduct study procedures; travels to study sites to train when needed; assists in developing training modules/documents
• Monitors data collected for studies at both external sites (travel within Alberta required) and local sites
• Acts as the primary contact and support for all external study sites; provides assistance and solutions to external study sites as needed
• Identifies potential participants through interactions with pertinent health care and administrative staff, and chart reviews
• Screens potential participants as per inclusion/exclusion criteria of specific protocols
• Explains study protocols and procedures and obtains informed consent from participating study subjects
• Collects clinical and other study data through subject interviews and clinical record reviews (NETCARE, etc.)
• Collects, processes and delivers biological samples to related study laboratories; performs clinical related study procedures such as venipuncture and bio-impedance testing if needed; documents serious and minor adverse events for regulatory overview
• Enters collected data into the appropriate electronic databases; retrieve additional data or correct existing data; respond to database queries
• Participates in any inside or outside study training activities
• Assists the supervisors in the design of the study database applications (RedCap); creates database Excel programs for small study projects
• Assists supervisors with quality assurance activities; runs regularly scheduled queries of study databases, identifies gaps or errors in data and corrects, revises or collects required data; distributes quality assurance work to study assistants and research assistant
• Develops manuals in collaboration with supervisors; updates and revises manuals as required

Qualifications

• The ideal candidate will have a post-secondary degree in Health Sciences or a professional designation in a health/research field (eg. Registered Nurse, CCRA/CCRP, etc.); equivalent combinations of education and experience will be considered
• One to two years of related experience
• Excellent time management skills
• Strong written and verbal communication skills
• Excellent organization skills and attention to detail 
• Strong computer skills with expert knowledge of MS Office Suite and Google applications