Clinical Research Coordinator, Department of Medicine

at  The University of Calgary

Description
The Department of Medicine in the Cumming School of Medicine invites applications for a Clinical Research Coordinator. This Part-time Fixed Term position is for approximately 1 year (based on length of grant funding), with the possibility of extension.
This position reports to the Research Manager of the Nephrology Research Program.
The team is engaged in clinical trial research in all areas of kidney disease management, evaluation, interventional, observational, & qualitative clinical studies. This includes studies in Phases 2, 3 & 4, Industry Sponsored, Investigator Initiated studies of drug/device safety and efficacy. The Clinical Research Coordinator will be part of an established and dynamic team that will work closely with the Research Manager and Nephrology Principal Investigators.
The Clinical Research Coordinator plays an essential and dynamic role in the coordination of clinical trial research. They are expected support, execute, and evaluate multiple clinical trial projects within our program. The schedule may not be fixed days or set hours and may require flexible hours during the day and evenings to accommodate study and patient schedules. The incumbent must have own transportation to be able to travel between sites within Alberta Kidney Care.
Summary of Key Responsibilities (job functions include but are not limited to):

Clinical Research Coordination:

• Responsible for the successful execution 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 Calgary, applicable regulatory bodies, and the research ethics board
• Implement plans for clinical trial work including but not limited to evaluating protocols; setting priorities for themselves; evaluating, monitoring and revising recruitment plans; developing, negotiating, and monitoring study budgets; completing ethics applications; study contract process functions
• Assists in performing feasibility assessments of patient population and helps to analyze specific study protocol inclusion / exclusion criteria against standards of care at the site
• Reporting to the Research Manager, supervise day to day research activities, monitor and report on clinical study status, deliverables, and finance on a regular basis
• Administers requests for use of clinical data for research purposes including oversight of processes, compliance with regulations, set-up and negotiating data, service, and privacy agreements
• Support the revisions and developments in the application and maintenance of standard operating procedures (SOP’s) and internal policies and procedures related to research activities for the Nephrology Research Clinical Group
• Coordinates and cooperates with the University of Calgary, Cumming School of Medicine, and external entities (i.e. Health Canada, FDA, Industry Sponsors) in compliance and monitoring efforts related to clinical trials
• Under the direction of the PI and Research Manager, is responsible to respond to any audit findings and implement approved recommendations for the clinical research portfolio/team
• Demonstrates advanced understanding and applicable training in the access, use and disclosure of personal and health related information in accordance with federal/provincial regulations, University of Calgary, Ethics boards, and Sponsoring agencies
• Demonstrates knowledge of various Cumming School of Medicine University department functions and AHS research administrative approval processes
• Monitor and maintain stock supplies of clinical trial study drug and clinical trial supplies applicable to each study/research protocol
• Manage research protocols (review, feasibility, training), ethics submissions (including but not limited to - applications, modifications, renewals, deviations, closures) and all research contract agreements
• Responsible for reporting of adverse and serious adverse events according to the study protocol and in accordance with local ethics board, regulatory agencies and sponsor requirements

Communication / Interaction / Compliance monitoring:

• Communicates and works with internal and external research parties, along with the PI and research manager identifies national and international clinical research opportunities
• Ensure all projects and research activities in the clinical research program adhere to ethical guidelines and legal requirements for research
• Implements clinical study protocols, monitor daily study activity, and prepare reports to investigators as appropriate
• Establishes and maintains good working relationships with all team members and external parties
• Work with PI and research manager to develop communication strategies and tools and to ensure applicable clinical research communications are up to date and accurate
• Accurate and timely preparation of periodic clinical trial progress reports and presentations
• Identifying the needs of co-workers, provide support, assistance, and mentorship in a positive, open approach within the research team to foster the growth of team members to achieve success in all projects
• Tact and diplomacy when dealing with and interacting with others

QUALIFICATIONS / REQUIREMENTS:

• Licensed Practical Nurse (LPN) active designation required; RN designation an asset
• Applicants must have advanced experience in clinical trial research and have an expert understanding of health care delivery in both community and acute care settings
• Certified Clinical Research Professional (CCRP) designation preferred
• Minimum of 5 years of relevant work experience in clinical research in an academic setting including significant experience managing Health Canada regulated clinical research trials
• Experience in hemodialysis and nephrology related nursing preferred
• Phlebotomy Certificate required
• Vaccination status in accordance with University of Calgary and Alberta Health Services standards and requirements
• Experience performing Electrocardiograms an asset
• SPOR Pragmatic Clinical Trials certificate an asset
• Significant experience managing research protocols, ethics submissions, research agreements/contracts, budget negotiations, financial reporting, and project progress reporting
• Experience in working in academic health research setting with researchers, practitioners and patient groups
• Functional knowledge of OnCore clinical trial management system
• Demonstrated ability to lead and provide advice, direction, problem-solving techniques to 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
• Strong organizational, time management and problem-solving skills
• Previous experience managing multiple projects and deliverables with competing priorities/deadlines
  Application Deadline: February 5, 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.

Please refer the Job description for details