Cto Clinical Trials Project Lead

This position is a part of the Non-Academic Staff Association (NASA).

This position offers a comprehensive benefits package which can be viewed at: Faculty & Staff Benefits .

Location

Work will mainly take place at College Plaza Campus and University of Alberta Hospital.

Working for the University of Alberta

The University of Alberta acknowledges that we are located on Treaty 6 territory, and respects the histories, languages and cultures of First Nations, Métis, Inuit and all First Peoples of Canada, whose presence continues to enrich our vibrant community.

The University of Alberta is teeming with change makers, community builders, and world

shapers who lead with purpose each and every day. We are home to more than 40,000 students in 200+ undergraduate and 500+ graduate programs, over 13,000 faculty and staff, 260,000 alumni worldwide and have been recognized as one of Canada’s Greenest Employers for over a decade.

Your work will have a meaningful influence on a fascinating cross section of people—from our students and stakeholders, to our renowned researchers and innovators who are quite literally curing diseases, making discoveries and generating solutions that make the world healthier, safer, stronger, and more just.

Position

Reporting to the Director of Operations of the Clinical Trials Office (CTO), the Clinical Trials Project Lead will develop, implement, manage and evaluate research and administrative strategies essential to the successful conduct of clinical trial projects overseen by the University's CTO. The successful candidate will provide leadership to the project team and assume responsibility for the overall operation, coordination and project management aspects of clinical projects, and serve as the primary contact with third parties for project related activities.

Duties

• Assists in the development and maintenance of project-specific databases to provide project status reports, historical data and fulfill regulatory requirements.
• Participates in planning and execution of meetings (investigator), including development and/or presentation of project-specific material to facilitate communication between study team members and site personnel.
• Prepares Case Report Forms, in-service and site support materials, study manuals and project newsletters specific to a clinical trial project including informed consent templates and investigator communication.
• Monitors, assesses and manages project statuses on an ongoing basis to ensure project objectives are met in a timely and cost-efficient manner.
• Supervises data management processes to ensure adherence to established policies, procedures and project-specific Standard Operating Procedures. Generates and/or facilitates implementation of ideas for increasing efficiency/productivity/quality of data. Monitors data flow from clinical sites to data management, review data and generate data queries as required. In conjunction with CTO Director of Operations and other members of the research team, prepares statistical analysis and reporting of project results.
• Assesses and communicates project resource requirements, proactively anticipates project issues and develops strategies for resolution on an ongoing basis to ensure successful project completion.
• Develops and maintains status reports for clinical projects. Assists with tracking and reporting of Serious Adverse Events as required to fulfill regulatory requirements.
• Develops project protocols and associated plans and materials, in conjunction with the CTO Quality Control Specialist and other members of the research team. Contributes to the ongoing review and modification of protocols to ensure continuing relevancy and subject safety.
• Provides a knowledgeable resource for site questions and issues. Provides clinical guidance to PIs and study coordinators when needed. Evaluates site issues and provides referral to CTO, HREB and VPR when appropriate.
• Distributes, collects, reviews and approves required regulatory documentation from clinical trial sites.
• In conjunction with the CTO Director of Operations, identifies, evaluates and recruits research sites. Reviews protocol requirements with site personnel and assists in feasibility analyses to ensure successful completion of the project by the site.

Qualifications

• Well-developed interpersonal communication skills, both oral and written.
• Minimum Bachelor’s degree in a health-related field. Master’s degree and/or completion of additional clinical research education (e.g., ACRP, SoCRA) are desirable. Equivalent combinations of education and experience will be considered.
• Team building skills and ability to work successfully in a team environment.
• Demonstrated ability to manage multiple projects and cross-functional teams.
• Intermediate computer experience: MS Word, MS Excel, MS PowerPoint, Outlook. Data management experience is desirable.
• Minimum of four years clinical trial experience including site monitoring and project coordination responsibilities.
• In-depth knowledge of clinical trial and drug development processes; ICH-GCP, FDA and TPD regulatory requirements.