Reporting to the Research, Grants and Finance Manager the Research and Quality Improvement & Patient Safety Coordinator will lead and support the ongoing operation of quality improvement (QIPS) and research studies in the Department of Emergency Medicine. The incumbent’s duties will include such aspects as assisting with the design and development of projects. They will work collaboratively with internal investigators, participating external sites, and industry partners in an evolving research/QIPS environment, ensuring awareness and understanding of study design, goals and procedures in compliance with ICH-GCP, Health Canada Regulations, and other relevant guidelines within the department. The incumbent will perform a wide array of duties including but not limited to: clinical data retrieval, programming excel for data summaries, reviewing data for accuracy and relevance, orchestrating the evaluation of potential adverse events, facilitation data cleaning, screening for and recruiting research participants, obtaining consent, and sample collection, data abstraction, data entry, participant follow up and administrative duties related to the conduct of research in the Emergency Department.
The incumbent must be able to work non-traditional hours to accommodate a patient centred approach.
• Lead and support ongoing QIPS and research projects in the Department of Emergency Medicine
• Assist with the supervision and training of Research Assistants through the coordination of work activities and delegate’s tasks as required.
• Serve as the departmental contact, liaison, or communicator with respect to the Principal Investigator’s research/QIPS program within the Department.
• Ensure flow of information out of department to other units and outside agencies and monitor flow of information into the department.
• Retrieve electronic health data and program recurring data summaries in Excel for multiple QIPS projects.
• Problem solve how to access electronic data to monitor QIPS projects.
• Create recurrent data summaries for QIPS projects.
• Monitor and adapt databases to ensure accuracy and efficiency and make recommendations for improvements.
• Assess and interpret data, establish metrics/reports, monitor for unexpected trends in participant accrual, eligibility, and patterns of practice which may compromise a project’s integrity.
• Schedule, recruit, and follow-up with study participants. This includes but is not limited to screening for eligibility, determining eligibility, obtaining consent, overseeing any interventions, data abstraction, data entry, and follow-up.
• Interact with internal departments (e.g., REB, Biostatisticians, pharmacy etc.) to ensure timely conduct of studies.
• Notify the Principal Investigator and follow procedures should an event potentially be deemed a serious adverse event; interact with the Research Ethics Board for the reporting of adverse events, protocol amendments and other study related events.
• Participate in study-related meetings like site evaluations, initiation and close-out visits, investigator meetings, monitor visits, study conference calls and regulatory audits.
• Act as a resource for questions about study design, conduct and data capture.
• Collaborate to establish and maintain project protocols and suggest appropriate modifications in procedures to ensure desired outcome.
• Ensure study procedures are followed and produce relevant documentation regarding participant enrollment.
• Collect data from participants and from medical records of participants involved in a research project or study. Enter data into an electronic database and review data quality. Maintain accurate and confidential records of these data. Perform basic analyses of these data and generate reviews.
• Independently manage time in order to assist with a number of concurrent research projects effectively. Monitor progress of projects and notify principal investigator of any adverse outcomes.
• Assist with creation of ethics applications and renewals.
• Perform administrative duties on behalf on the research office.
• Undertake other duties or special projects as required in support of the department.
• University Degree or Master’s Degree in health science or relevant field.
• Minimum 5 years of relevant experience, conducting research and analysis, clinical trial management, or as a lab coordinator.
• Experience in medical, research, clinical trials, health sciences, nursing, or laboratory technology is an asset.
• Prior QIPS training or experience with QIPS project management is an asset.
• Consideration may be given to an equivalent combination of education and experience.
• Excellent communication (both oral and written) and interpersonal skills, and the ability to interact effectively with a diverse range of patients, families, healthcare professionals, researchers and external stakeholders.
• Organization and time management skills to coordinate of research teams.
• Ability to focus under pressure and with frequent interruptions, while managing stakeholder expectations and competing deadlines.
• Advances skills in Microsoft Excel programming.
• Prior experience in working with large data sets.
• Superior attention to detail with sound judgment and strong problem-solving skills.
• Supervisory and leadership skills to provide guidance and support to Research Assistants.
• Must be self-motivated and be able to work independently or as a team member.
• Ability to maintain strict confidentiality with tact and discretion.
• Respects diversity and promotes inclusion in the workplace.
• Ability to interact with health care team in a very busy Emergency Department in a proactive, productive, and respectful manner.
• Patient-centered approach to research/QIPS including excellent interpersonal and communication skills, to interact with a diverse group of patients and colleagues.
• Capacity to critically and accurately review and interpret medical data for the purposes of screening for eligible participants.
• Understanding of IT systems capabilities including electronic data captures systems (Redcap, Medidata).
• Strong knowledge of Microsoft Office.
• Awareness of statistics and data checking concepts.
• Organizational, problem-solving, and analytical skills.
• Judgment in choosing the best protocol or adapting procedures to meet changing needs.
• Excellent problem solving and analytical skills.
• Make decisions regarding setting up data capture for new QIPS projects.
• Make independent decisions in response to issues arising in the study development and ongoing study management, and refer all serious issues to the Principal Investigator.
• Recommend alternative procedures as required during the progress of the study.
• Determine if a protocol is being followed; recommend how best to resolve. Find solutions to unanticipated problems and decide whether the problem warrants involvement of more senior staff.
• Monitor and assess output and the quality of Research Assistant’s work and recommend need for training or development plans to management and identifies possible staff performance and/or disciplinary issues.
• Determine if potential participants meet criteria for research trials by evaluating materials submitted or ensuring that they complete specific questionnaires.
• Evaluate participant status and take appropriate actions during tests and other experimental procedures.
• Determine how to best obtain consent from patients.
• Identify adverse events related to study interventions and report to senior staff as required.
• Direct research inquiries to the proper person or supply the answer if appropriate.
• Decide what to do when encountering an unexpected problem while performing an experiment or respond to equipment breakdown and decide when the problem is complex enough to contact a senior staff.
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