Clinical Trial Project Lead

**Department** Faculty of Medicine & Dentistry - Medicine Dept

**Salary range** $78,694.13 to $110,457.10

**Hours per week** 40

**Grade** 12

**Posted date** September 12, 2024

**Closing date** September 23, 2024

**Position Type** Full Time - Trust Funded

**Description**:
**_This position is a part of the Non-Academic Staff Association (NASA)._**

This position offers a comprehensive benefits package which can be viewed at: Faculty & Staff Benefits.

**Location** - This role is hybrid with a mix of remote and in-person work at North Campus Edmonton.

**Working at 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 FirstPeoples of Canada, whose presence continues to enrich our vibrant community._

The University of Alberta is a community of knowledge seekers, change makers and world shapers who lead with purpose each and every day. We are home to over 14,000 faculty and staff, more than 40,000 students and a growing community of 300,000 alumni worldwide.

Your work will have a meaningful influence on a fascinating cross-section of people — from our students and community members, to our renowned researchers and innovators, making discoveries and generating solutions that make the world healthier, safer, stronger and more just. Learn more.

**Working for the Canadian VIGOUR Centre**

The Canadian VIGOUR Centre (CVC) is an Academic Research Organization (ARO) committed to enhancing cardiovascular health. Our centre provides leadership in clinical trials of cardiovascular therapies from study design to manuscript publication, developing selected registries, and informing clinical practice through insights gained from population health data. The CVC is anchored by a dedicated group of internationally recognized thought leaders in cardiovascular medicine and clinical investigation and supported by accomplished administrative and clinical operations teams and experienced biostatisticians, data analysts, and ECG Core Laboratory personnel.

**Position**

**Duties**
- Monitors, assesses and manages project status on an ongoing basis to ensure project objectives are met in a timely, cost-efficient manner.
- Assesses and communicates project resource requirements, proactively anticipate project issues and develops ongoing resolution strategies to ensure successful project completion.
- Provides leadership and guidance to research sites to ensure that each project complies with sponsor timelines, study protocols, Standard Operating Procedures (SOPs), ethics guidelines and other applicable regulatory requirements
- Develops project plans. Proactively anticipates project issues and develops strategies for resolution on an ongoing basis to ensure successful project completion on time and on budget. Responsible for ensuring all trial-related activities are delivered within the trial timelines as laid out in the scope of work.
- Proactively assesses risk, analyzes identified issues as they arise and provides effective solutions for the successful project continuation; communicates any resulting revised procedures/protocols to all participating project sites to ensure consistency.
- Works with project team members in identifying priority tasks and providing expertise and team leadership.
- Responsible for ensuring all operational aspects of the project are completed and accurately documented throughout each phase of the study, including site identification/feasibility, site selection, start-up process with each site, regulatory completeness, site activation, ensuring ongoing site recruitment and enrollment are in line with the study projections, ensuring follow up regularly with sites through the enrollment and follow up period on data entry, ensuring timelines are met for database lock and working closely with sites through closeout and archival of the study.

**Minimum Qualifications**
- Minimum of an undergraduate degree in science or health-related field; BScN is desirable.
- An advanced degree and/or completion of additional clinical research education (e.g., ACRP, SoCRA) is desirable.
- Minimum four years of clinical trial experience, including site monitoring and project coordination responsibilities.
- In-depth knowledge of clinical trial and drug development processes; ICH-GCP, FDA and Health Canada regulatory requirements.
- Demonstrated ability to manage multiple projects and cross-functional teams.
- Well-developed interpersonal communication skills, both oral and written.
- Team building skills and ability to work successfully in a team environment.

**Preferred Qualifications**
- Bilingual English/French is an asset
- Intermediate computer experience: MS Word, MS Excel, MS PowerPoint, Gmail, SharePoint, Clinical Trial Management System (CTMS).
- Data management experience with Clinical Trial Databases (INFORM, RAVE, RedCAP)

We thank all applicants for the