Project Manager, Investigator Initiated Trials

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.

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.

Bachelor's degree in a related field required. Minimum of 5 years clinical trials experience, with excellent understanding of clinical trials operations, set up and daily coordination. Must have a strong understanding of Good Clinical Practice and Health Canada Division 5 regulations.

Strong leadership skills, interpersonal communication, conflict resolution, writing, presentation, and facilitation skills. Proven organizational skills demonstrated by prior experience in project management or coordination of multidisciplinary teams. Demonstrated problem-solving and critical thinking skills. Proven ability to prioritize tasks to meet various deadlines, while managing multiple projects simultaneously. Excellent computer skills using MS Office applications (Word, Excel, PowerPoint), Internet Explorer and Outlook Email, as well as experience using other project management or related computer programs/databases (e.g., Connect Care, eCRF's, Redcap, IRISS, etc.). Strong team building skills and the ability to work both independently and within a team structure are also necessary. Physical demands of the job include sitting for extended periods, lifting office/medical supplies and equipment weighing up to 40 lbs., and using repetitive motions, lifting, bending, reaching and standing for prolonged periods. To ensure your skills and qualifications are considered, please attach a resume and cover letter with your application noting how your current training and experience meet the requirements of this position.

Knowledge of oncology disease and treatment. Completion of an approved Clinical Research or Project Management Program. SOCRA or ACRP membership/certification. Knowledge in study databases with advanced data management skills and extensive experience creating Case Report Forms in databases is an asset. Experience with clinical trial inspections, and monitoring requirements and procedures.