Your Opportunity:
Be part of the leading edge of cancer treatment and join our Cross Cancer Institute Clinical Trials Unit. The Investigator-Initiated Trial (IIT) Project Manager will use their vast clinical trials experience to lead the set up and implementation of funded investigator-initiated cancer trials. They will work closely with our physicians (Principal Investigator-PI’s) to help ensure that properly constructed, ICH-GCP-compliant study protocols are developed. The project manager will also ensure that all necessary clinical trial approvals are obtained, and required logistics are put in place, working with our Regulatory team and Clinical Trials tumor group staff to plan and implement smooth study operations, while ensuring projects are in compliance with applicable local laws and regulations. This position requires considerable organization and regular collaboration with the PI, Clinical Trials Unit staff, Research Ethics and AHS or UofA Research staff, along with other internal CCI, or external AHS staff & departments, and related sponsors (CRO/Pharmaceutical where applicable) and regulatory agencies.
Description:

Develop protocol procedures and coordinate set up of investigator-initiated trials (IIT’s) in line with protocol requirements and project funding. Design and create case report forms and other related study documents. Develop and organize study processes for randomization, specimen handling, data capture, study team communication resources, tracking tools, and patient handouts as required. Assist investigators in preparing applications to the CCI regional IIT committee. Complete ethics submissions and coordinate with AHS Research Administration to secure research agreements & data transfer agreements as required. Manage relationships with both internal and external departments as necessary for each project. Act as lead and central resource for multi-site study activations. Prepare reports for management or project tracking and summaries as required. Apply Good Clinical Practice, and applicable regulatory requirements to the conduct of Investigator Initiated trials. Assist with Health Canada submits, and amendments as needed. Participate in committees related to investigator-initiated trials. Act as ongoing resource and support to Principal Investigators, nurses, and clinical trial coordinators conducting Investigator Initiated cancer trials. Identify and establish process improvement initiatives within the IIT program.

• Acute Care Alberta: N
• Primary Care Alberta: N
• Recovery Alberta: N
• Classification: Project Manager
• Union: Exempt
• Unit and Program: Clinical Trials Unit, Cancer Care
• Primary Location: Cross Cancer Institute
• Location Details: As Per Location
• Employee Class: Regular Full Time

Please refer the Job description for details