University of Alberta

QM Clinical Trials Project Lead

Quality Mgmt in Clinical Research

Competition No.  -    S106939838
Posting Date  -    Aug 12, 2019
Closing Date  -    Sep 10, 2019
 
Position Type  -    Full Time - Grant Funded
Salary Range  -    $76,574 to $107,481 per year
Grade  -    12
Hours  -    40

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

Reporting to the Senior Manager of the Quality Management in Clinical Research (QMCR) Office, 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 QMCR Unit. 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

  • 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.
  • Develops project protocols and associated plans and materials, in conjunction with the QMCR 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.
  • In conjunction with the QMCR Advisor, 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 QMCR Advisor 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 QMCR, 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

Apply Online

Note: Online applications are accepted until midnight Mountain Standard Time of the closing date.

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

The University of Alberta is committed to an equitable, diverse, and inclusive workforce. We welcome applications from all qualified persons. We encourage women; First Nations, Métis and Inuit persons; members of visible minority groups; persons with disabilities; persons of any sexual orientation or gender identity and expression; and all those who may contribute to the further diversification of ideas and the University to apply.