Clinical Research Coordinator

Competition 906

This competition is open to all applicants however internal candidates and applicants who were former employees of the University of Alberta in the past 18 months will be given priority consideration before external candidates. Please log in to verify your internal candidate status.

This position is a part of the Non-Academic Staff Association (NASA).

This position has a term length of 1 year plus 1 day and offers a comprehensive benefits package which can be viewed on our Benefits Overview page.

Location - This role is hybrid with a mix of remote and in-person work at North Campus Edmonton.

Working at the University of Alberta

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Your work will have a meaningful influence on a fascinating cross-section of people — from our students and community members, to our renowned researchers and innovators, making discoveries and generating solutions that make the world healthier, safer, stronger and more just. Learn more.

Position 

The Clinical Research Coordinator position within the Kidney Health Research Group in the Department of Medicine is integral to our commitment to diversity, equity, and inclusion. Reporting to the Principal Investigator (PI), this role is pivotal in orchestrating and overseeing clinical research endeavors. The incumbent will spearhead the development, execution, coordination, and assessment of multiple clinical research and trial processes within our program.

Working closely with Principal Investigators, the Research Manager, Sponsor representatives, clinical research staff, Institutional departments, and research participants, the Clinical Research Coordinator plays a central role in conducting a diverse range of clinical research studies. Operating with autonomy and requiring minimal supervision, the Coordinator adeptly juggles multiple competing priorities to meet project deadlines and objectives. Resourcefulness, creativity, and innovative problem-solving skills are paramount in this capacity.

The ideal candidate will possess demonstrated analytical acumen applicable to various research and development realms, where the margin of error ranges from moderate to high impact. Additionally, this role entails fostering and sustaining relationships among diverse research members, staff, organizations, and stakeholders (e.g., AHS, Alberta Precision Laboratories, Diagnostics departments, CCCR, CSM Legal). Furthermore, the incumbent will serve as a mentor and supervisor to team members, nurturing a collaborative and inclusive work environment.

The schedule for this position may not adhere to fixed days or set hours, requiring flexibility during both daytime and evening hours to accommodate the diverse needs of our team members, patients, and study participants. Additionally, this role involves regular travel between study locations situated across various hospital sites within the city on a weekly basis.

Duties 

Clinical Research Coordination (80%)

• Responsible for delegated tasks related to research protocols (review, feasibility), ethics submissions (including but not limited to - applications, modifications, renewals, deviations, closures), and all research contracts and vendor agreements.
• Responsible for the successful coordination work of one or more simultaneous studies in accordance with protocols, applicable contracts, budget requirements, and in compliance with all policies, procedures, and guidelines of the research group, the University of Alberta, applicable regulatory bodies, and the research ethics board.
• Demonstrates capable knowledge in all aspects of clinical and pragmatic clinical trial coordination including but not limited to screening, informed consent process, randomization, IP dispensation, vital sign assessment, ECGs, treatment, and follow-up of study subjects, working within electronic clinical information systems, data management, project closure activities, monitoring, and audits and other protocol specific tasks as delegated by the PI.
• Responsible for reporting adverse and serious adverse events according to the study protocol and in accordance with the local ethics board, regulatory agencies, and sponsor requirements
• Prepares study files as delegated by the PI. These study materials include but are not limited to regulatory binders, informed consent documents, case report forms (CRFs), enrollment logs, drug/device accountability logs, and study-specific source documents.
• Reporting to the Principal Investigator, monitor day-to-day research activities, report on study status, and deliverables regularly.

Communication / Interaction / Compliance monitoring (20%)

• Communicates and works with internal and external research parties, along with the PI.
• Ensures the projects and research activities adhere to ethical guidelines and legal requirements for research.
• Implements clinical study protocols, monitors daily study activity, and prepares reports to PI as appropriate.
• Establishes and maintains good working relationships with all team members and external parties.
• Works with PI to develop communication strategies and tools and to ensure applicable clinical research communications are up-to-date and accurate.

Minimum Qualifications

• Minimum Bachelor’s degree in a health sciences field (e.g. BScN) or a Master's degree in a relevant field. A PhD degree in a relevant field is an asset
• Minimum of 5 years of relevant work experience in clinical research including significant experience in the startup and management of clinical research trials
• Understanding of health care delivery in both community and acute care settings
• Demonstrated ability to interact and work with members of the research team with integrity, honesty, and professionalism
• Ability to facilitate collaborative project management delivery across multidisciplinary departments within the University, Alberta Health Services (AHS), Alberta Precision Laboratories as well as with other universities, research programs and private organizations
• Demonstrated proficiency in organizational, time management, and problem-solving abilities
• Track record of successfully coordinating multiple projects and deliverables amidst competing priorities and deadlines
• Proactive approach in taking initiative, setting priorities, and seamlessly working both independently and collaboratively within a team
• Exceptional organizational, interpersonal, and communication skills, evidenced in both written and oral contexts
• Strong dedication to precision, with attention to accuracy and detail
• Flexible availability to accommodate varying work hours and contribute to meeting team priorities and deadlines
• Commitment to leveraging conflict management and negotiation skills to foster constructive collaboration and resolution
• Must be proficient in standard system software applications (e.g. MS Word, Excel, Outlook, PowerPoint)

Preferred Qualifications

• Certified Clinical Research Professional (CCRP) designation preferred
• RN active designation preferred
• SPOR Pragmatic Clinical Trials certificate preferred
• Working knowledge and experience with ICH-GCP requirements, HIA, PIPA, FOIP, TCPS2, HCDiv5, and FDA regulations preferred
• Experience working with/on research protocols, ethics submissions, research agreements/contracts, financial reporting, project progress reporting, and scientific writing skills preferred
• Experience in nephrology-related care is considered an asset
• Experience in performing Electrocardiograms is considered an asset
• Experience working in an academic health research setting with researchers, practitioners and patient groups is considered an asset
• Experience with the University of Alberta financial, human resource, and supply chain management systems and procedures is considered an asset
• Project management and/or research certifications (e.g. CCRP) are considered assets
• Familiarity with knowledge translation and qualitative research methods (including patient focus groups and surveys [i.e. Fluid Surveys, Simple Survey]) are considered assets