Pretrial Working Leader

4 days ago

Edmonton, Alberta, Canada Alberta Health Services Full time
Opportunity Overview

Be part of the leading edge of cancer treatment and join our Cross Cancer Institute Clinical Trials Unit. As a Pretrial Working Leader, you will oversee and supervise trial prelaunch processes, ensuring timely, efficient, and accurate start-up of complex clinical trials related to study-specific therapy treatments involving electronic medical records.

Key Responsibilities
  • Coordinate Trial Initiation Team Activities, acting as the main point of contact for Investigators, staff, pharmaceutical sponsors, CROs, and Cooperative/Consortium groups for all trial prelaunch processes related to electronic medical records.
  • Manage submission of all protocol documents to the proper areas to initiate prelaunch activities, develop standardized processes, and prioritize the intake process for all studies, including study amendments.
  • Coordinate local and provincial reviews of prelaunch activities between the two primary Alberta Cancer Centres.
  • Act as the escalation point for prelaunch-related activities, monitor progress of project milestones, and regularly update master lists and trackers.
  • Liaise with Investigator Initiated Trials (IIT) and Cellular Therapy Project Managers regarding new trials, and the Sr. Coordinator Quality Regulatory Compliance regarding regulatory requirements.
  • Create and present training materials to new staff and perform ongoing training for existing staff.
  • Coordinate management of unit-specific research trial template builds and ensure trial prelaunch activities are in place prior to initiation.
  • Provide updates and reports to management, ensuring that all new trial information is entered into applicable clinical trial management systems allowing appropriate integration.
  • Troubleshoot logistical challenges related to prelaunch by monitoring activities and issues while improving internal processes.
Requirements
  • Bachelor's degree in Science, Health, or Clinical Research-related field is required.
  • Oncology Training in Connect Care is required.
  • ACRC/SOCRA Certification is preferred.
  • Oncology Clinical Trials Research Experience is preferred.
  • Experience presenting/training in a classroom setting is preferred.
  • Prior experience supervising staff is preferred.

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