Clinical Trial Project Lead

at  University of Alberta

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

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, Métis 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 September 23, 2024, Edmonton, Alberta local time

• 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 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.