CTO Clinical Trials Project Lead

2 weeks ago

Edmonton, Canada University of Alberta Full time

**MED Quality Mgmt Clin Resch**:

- Competition No.

**S100351186**
- Posting Date

**May 29, 2023**
- Closing Date

**Jun 07, 2023**
- Position Type

**Full Time - Grant Funded**
- Salary Range

**$77,531 to $108,824 per year**
- Grade

**12**
- Hours

**40**

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 primarily takes place in person at North Campus, Edmonton, with some flexibility to work remotely.

**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**

**Duties**
- Monitors, assesses and manages project statuses on an ongoing basis to ensure project objectives are met in a timely and cost-efficient manner.
- Assesses and communicates project resource requirements, proactively anticipates project issues and develops strategies for resolution on an ongoing basis to ensure successful project completion.
- 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.
- 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.
- 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.
- Assists in the development and maintenance of project-specific databases to provide project status reports, historical data and fulfill regulatory requirements.
- Distributes, collects, reviews and approves required regulatory documentation from clinical trial sites.
- 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.
- Develops and maintains status reports for clinical projects. Assists with tracking and reporting of Serious Adverse Events as required to fulfill regulatory requirements.
- 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.

**Qualifications**
- 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.
- 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.
- Demonstrated ability to manage multiple projects and cross-functional teams.
- Well-developed interpersonal communication skills, both oral and written.
- Team building skills and ability to work successfully in a team environment.
- Intermediate computer experience: MS Word, MS Excel, MS PowerPoint, Outlook. Data management experience is desirable.

**How to Apply**

**We thank all applicants for their interest; however, only those individuals selected for an interview will be contacted.

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