Job Description

DescriptionThis position is a part of the Non-Academic Staff Association (NASA).This position offers a comprehensive benefits package which can be viewed at: .Location - This role is hybrid with a mix of remote and in-person work at North Campus Edmonton.Working at the University of AlbertaThe University of Alberta acknowledges that we are located on Treaty 6 territory, and respects the histories, languages and cultures of First Nations, M\xc3\xa9tis, Inuit and all First Peoples 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 more than 14,000 faculty and staff, over 40,000 students and 260,000 alumni worldwide.Your work will have a meaningful influence on a fascinating cross-section of people \xe2\x80\x94 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. .Working for the Department of MedicineThe University of Alberta\'s Department of Medicine is a recognized leader in innovative education, world-class research and outstanding patient care.We are the largest department in the Faculty of Medicine & Dentistry and the biggest at the University of Alberta. More than 1,100 academic and clinical faculty, students, residents and fellows help achieve our goal of improving health and health care locally and globally. These efforts are supported by more than 300 health, technical and support staff.The Department of Medicine includes 14 divisions and serves communities throughout Northern Alberta and parts of British Columbia, Saskatchewan and the Northwest Territories.A successful partnership with Alberta Health Services that emphasizes innovation and care allows us to attract the world\'s top medical minds and researchers to build a successful foundation for the next generation of health care leaders.PositionThe Clinical Trials Project Lead (CTPL) develops, implements, manages, and evaluates research and administrative strategies essential to successfully conducting National and international clinical trial projects. The successful candidate leads project teams and research site personnel located at participating sites across Canada on one or multiple projects. This position assumes responsibility for the clinical trial projects\' overall operation, coordination and project management aspects. It is responsible for reporting trial status, metrics and performance to academic partners, sponsors and trial leadership.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.
• Develops project protocols and associated plans and materials with the National Director and other research team members. Contributes to the ongoing review and modification of protocols to ensure continuing relevancy and subject safety.
• 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 revisedprocedures/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)

At the University of Alberta, we are committed to creating an inclusive and accessible hiring process for all candidates. If you require accommodations to participate in the interview process, please let us know at the time of booking your interview and we will make every effort to accommodate your needs.We thank all applicants for their interest; however, only those individuals selected for an interview will be contacted.The University of Alberta is committed to an equitable, diverse, and inclusive workforce. We welcome applications from all qualified persons. We encourage women; First Nations, M\xc3\xa9tis and Inuit persons; members of visible minority groups; persons with disabilities; persons of any sexual orientation or gender identity and expression; and all those who may contribute to the further diversification of ideas and the University to apply.Note: This opportunity will be available until midnight May 14, 2024, Edmonton, Alberta local time.

University of Alberta