PreTrial-Working Leader

Be part of the leading edge of cancer treatment and join our Cross Cancer Institute Clinical Trials Unit. The PreTrial Working Lead reports to the CTU Manager within the Cross Cancer Institute. They will oversee and supervise trial prelaunch processes, and subsequent/related updates with the Clinical Trial Unit. This is vital to the unit to facilitate timely, efficient, and accurate start-up of complex clinical trials related to study specific therapy treatments involving the readiness of clinical EMR (electronic medical records). This position serves as an internal liaison between the Clinical Trials Tumor Group staff, Principal Investigators and Management regarding study start-up. This position acts as an external liaison and Clinical Trial Unit representation for start-up with many EMR multidisciplinary teams. Considerable task tracking and communication are involved, and this person will act as the central point of contact. They will also arrange or assist with training or facilitate completion of the required tracking processes as developed by the related team(s) and work locally to help complete various related work task/packages, and develop processes as needed.

This position will oversee and coordinate Trial Initiation Team Activities, acting as the main point of contact for Investigators, staff, pharmaceutical sponsors, CRO’s & 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 & provincial reviews of prelaunch activities between the 2 primary Alberta Cancer Centres. Act as the escalation point for prelaunch related activities. Monitor progress of project milestones, and regularly update master lists & trackers. Liaise with the Investigator Initiated Trials (IIT), and Cellular Therapy Project Managers regarding new trials, and the Sr. Coordinator Quality Regulatory Compliance regarding regulatory requirements. Creates and presents training materials to new staff & performs ongoing training for existing staff. Coordinates management of unit specific research trial template builds & ensures trial prelaunch activities are in place prior to initiation. They will provide updates & reports to management, ensuring that all new trial information is entered into applicable clinical trial management systems allowing appropriate integration. They will troubleshoot logistical challenges related to prelaunch by monitoring activities & issues while improving internal processes. This role will provide daily supervision of study staff involved in coordination of prelaunch activities; SMEs with EMR trial activities. Monitor the distribution of workload amongst the Tumor Group CTNs & CTCs involved in the prelaunch activities & review any concerns or issues with the CTU Manager. They will also provide support & guidance to CTU staff about prelaunch activities.

Bachelor’s degree in Science, Health or Clinical Research related field is required. Oncology Training in Connect Care.

Minimum of 5 years related clinical trial experience in a healthcare, pharmaceutical/clinical research organization, research ethics or clinical setting is required. Proficient computer knowledge and experience in Microsoft Office including excel, word, power point, & MS Teams. Proficiency in knowledge, experience & utilization of Connect Care Platform and SharePoint. Attention to detail and excellent tracking skills. Strong track record in establishing and maintaining effective collaborative working relationships with internal and external stakeholders of multidisciplinary teams. Excellent communication skills and organizational skills. Exhibits proven leadership skills and abilities. **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.

ACRC/SOCRA Certification preferred. Oncology Clinical Trials Research Experience. Experience presenting/training in a classroom setting. Prior experience supervising staff.