Reporting to the Principal Investigator, the Research Coordinator/Assistant will lead and support the ongoing operation of studies in the Department of Critical Care. The incumbent’s duties will include such aspects as assisting with the design and development of research projects. They will work collaboratively with internal investigators, participating external sites, and industry partners in an evolving research 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 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 Critical Care Department.

The incumbent must be able to work non-traditional hours to accommodate a patient centered approach to research projects.

KEY RESPONSIBILITIES:
• Lead and support ongoing research projects in the Department of Critical Care
• Assist with the training of Research Assistants through the coordination of work activities and delegate’s tasks as required.
• Collect, organize, and input research data and complete case report forms for patients enrolled in studies.
• Serve as the departmental contact, liaison or communicator with respect to the Principal Investigator’s research 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.
• 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.
• Act as a resource for questions about study design, conduct and data capture.
• 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.
• Responsible for coordinating the preparation of grant and/or contract proposals for submission, for both individual research and research teams. This includes setting timelines, participating in meetings for the purposes of proposal development, review drafts, and proposal submissions. Responsible for editing, renewing and formatting of proposals.
• Conduct patient follow-up as required including, but not limited to, clinic interviews/assessments and telephone communication.
• Responsible for patient recruitment, obtaining consent from patients and surrogates and patient follow-up for the research studies assigned to the applicant. This includes confirming that the requirements for enrollment are met including that eligibility criteria are all present and none of the exclusion criteria are present.
• Independently manage time to assist with a number of concurrent research projects effectively. Monitor progress of projects and notify principal investigator of any adverse outcomes.
• Perform administrative duties on behalf of the Principal Investigator including scheduling of meetings, organizing, and maintaining appointments for interactions with other investigators, completion of documentation and coordination with other centers.
• Prepare draft manuscripts, protocols and presentations as required by the Principal Investigator along with creating procedural manuals.
• Undertake additional duties or special projects as required in support of the department.