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[Kelly Allen-Pitchko]

Reporting to the AVP (Research Integrity Support) in the Office of the Vice President (Research and Innovation) and providing support to the Clinical Trial Unit in FoMD (CTU) based on their operational needs and requirements, the Clinical Trial Monitor is responsible for the implementation of the quality control program for clinical research at the U of A. This critical control has been created to mitigate serious risks to the University. The clinical trial monitor will work extremely effectively with Principal Investigators (Pis), study coordinators (SCs), Alberta Health Services (AHS) and the Northern Alberta Clinical Trials and Research Centre (NACTRC) – a joint venture of the U of A and AHS that coordinates research administration for clinical research activities and clinical trials, Health Systems Access, and other academic institutions and health authorities.

The Clinical Trial Monitor will be responsible for developing and implementing clinical trial monitoring plans; promoting awareness of policies and procedures to researchers, faculties, departments, and other interested parties; collaborating with the Clinical Trial Unit in FoMD with outreach to the wider community and developing protocols and procedures for the administration of the quality control program. Failure to detect violations to the rights and safety of trial participants, fabrication of research data and non-compliance would result in a massive legal and reputational risk to the research enterprise and the institution as a whole. Supporting the CTU, and in coordination with the Senior Clinical Trial Monitor, the Clinical Trial Monitor will develop the quality control program for clinical research at the U of A and will be responsible for implementing and leading it. This role will act autonomously and report regulatory updates to the AVP and the CTU regularly. In support to the CTU and according to their needs, The Clinical Trial Monitor will develop, for their assigned portfolio of trials, the institutional monitoring plans, develop tools and standard operating procedures for participating sites and management tools for the monitoring team, and then serve as the primary contact for implementing/administering site-specific plans and managing the clinical monitoring activities.

Responsibilities include:

Monitoring Plans & Site Initiation Consultations
Periodic Risk-based Site Monitoring
Site Close-Out Visits
Supervision of Contracted Monitors
KNOWLEDGE, SKILLS AND ABILITIES:

University graduate degree required
Minimum of 3 year’s experience working in clinical trials as a trial coordinator or monitor
ICH-GCP certification
Health Canada Division 5 certification
ACRP certification (or eligibility to do so)
Exhaustive knowledge of Health Canada’s 1) Medical Devices Regulations (SOR/98-282), PART 3-Medical Devices for Investigational Testing Involving Human Subjects, 2) Food and Drug Regulations (C.R.C., c. 870), DIVISION 5-Drugs for Clinical Trials Involving Human Subjects, and 3) Natural Health Products Regulations (SOR/2003-196), PART 4-Clinical Trials Involving Human Subjects
Ability to travel domestically and internationally up to 60% of 1.0 FTE
Minimum of 3 year’s experience in a university administrative environment
Familiar with University of Alberta policies and procedures, particularly those related to research
Familiar with granting agency compliance requirements and expectations
General knowledge of University of Alberta governance and administrative structures
Detailed knowledge of University of Alberta Conflict Policy and its Procedures
Familiar with research activity and culture in a university setting
Familiar with Information Technology development and testing requirements (to implement a new tracking system)
Well-developed diplomatic and negotiation skills: tact and diplomacy are essential
Highly developed conflict resolution skills
Excellent organizational skills including time-management and well-developed multi-tasking skills
Efficient, effective and energetic self-starter
Ability to demonstrate professionalism with a high level of tact, discretion and the capability to maintain confidentiality
Excellent oral and written communications skills
Excellent interpersonal skills

Click HERE to learn more and/or to apply

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