Clinical Trial Monitor

3 weeks ago

Edmonton, Canada University of Alberta Full time

**VPRI Innovation**:

- Competition No.

**A109252393D1**
- Closing Date

**Feb 21, 2024**

This position is a part of the Association of the Academic Staff of the University of Alberta (AASUA).

In accordance with the Administrative and Professional Officer Agreement, this full time continuing position offers a comprehensive benefits package found at Faculty & Staff Benefits and annual salary range of $64,206 - $107,006.

**Location** - Work primarily takes place at North Campus, Edmonton.

**Working for the University of Alberta**
- The University of Alberta acknowledges that we are located on Treaty 6 territory, and respects the histories, languages and cultures of First Nations, Métis, Inuit and all First Peoples of Canada, whose presence continues to enrich our vibrant community._

The University of Alberta is teeming with change makers, community builders, and world shapers who lead with purpose each and every day. We are home to more than 40,000 students in 200+ undergraduate and 500+ graduate programs, over 13,000 faculty and staff, 260,000 alumni worldwide and have been recognized as one of Canada’s Greenest Employers for over a decade.

Your work will have a meaningful influence on a fascinating cross section of people—from our students and stakeholders, to our renowned researchers and innovators who are quite literally curing diseases, making discoveries and generating solutions that make the world healthier, safer, stronger, and more just.

**Working for VP Research and Innovation**

The University is committed to academic freedom and excellence in teaching and research. Over the past decade, research funding at the University of Alberta (U of A) has grown from $100 million per year to nearly $500 million per year. Revenues from clinical research and clinical trials account for a significant portion of that funding, and is trending to increase. In carrying out its mission, the University has established a Clinical Trials Office to oversee quality management for clinical research to ensure that clinical research at the University of Alberta is conducted to the highest possible standard.

**Position Summary**

The Clinical Trial Monitor plays a pivotal role in ensuring the successful execution of clinical trials at the University of Alberta. This position combines scientific acumen with regulatory compliance to oversee and optimize the progress of clinical research, contributing significantly to the university's commitment to advancing medical knowledge and improving patient outcomes.

Reporting to the Senior Officer, Clinical Trial Monitoring and as part of an integrated Clinical Trials Office, under the operational guidance of the CTO Director, the Clinical Trial Monitor is responsible for providing monitoring for IITs sponsored by the University of Alberta. Key components of the program include: clinical trial monitoring for quality control purposes; assisting with the design and coordination of training and education programs for researchers and their teams; developing and implementing clinical research monitoring policies and standards; establishing standard operating procedures; ensuring monitoring protocols are followed and maintained; and preparing researchers for industry sponsored, government and internal monitoring visits and audits.

The clinical trial monitor serves as a critical control to mitigate serious risk to human participants enrolled in these studies as well as to the University of Alberta. The emphasis of this position is to support compliance in the conduct of clinical trials sponsored by the University to ensure human participant’s rights or safety are protected, data collected and reported are accurate, and that all trials and their sub sites comply with local, national and international standards, policies and regulations for clinical research involving human participants.

**Duties**

**1.** Monitoring Plans & Site Initiation Consultations
- In collaboration with the Senior Officer and the Director of the Clinical Trials Office, develops and updates all site monitoring plans annually for low, medium and high risk trials. As required, revise monitoring plans for specific trials and communicate with study team for approval. Collect independent risk assessments from qualified personnel in order to determine clinical trial risk levels and inform the monitoring plan requirements.
- Review regulatory preparedness and sites’ ability to conduct clinical trials.

**2.** Periodic Risk-based Site Monitoring
- Conduct virtual and. in-person monitoring visits to sites within Canada within trial-specific time intervals to assure participant safety and well being, the integrity of clinical trial data (with respect to accuracy, accountability and documentation via the review of case report forms, source documents, medical records and regulatory documents), and compliance with local, provincial, federal and international policies, regulations and guidelines.
- Ensure proper sto

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