Salary Range: $74,618-$107,264/year. The starting salary for this position would be determined with consideration of the successful candidate’s relevant education and experience, and would be in alignment with the provincial compensation reference plan. Salary will be prorated accordingly for part time roles.

 

Job Summary:

 

Join PHSA’s Clinical Trial Support Team to assist researchers at BC Children’s Hospital, BC Women’s Hospital, BCCDC, and BCMHSUS in navigating regulated clinical trials. Learn more about our services at www.phsa.ca/clinical-research.

In accordance with the Mission, Vision and Values, and strategic directions of PHSA, safety is a priority and a responsibility shared by everyone at PHSA and as such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.

Reporting to Corporate Director, Clinical Trials Administration, and working closely with clinical trial and research personnel, the Project Manager (PM), CTMS assists with the set-up and management of clinical trial and research projects to improve processes, and achieve compliance with protocols, regulations and guidelines. The PM also provides project management services including planning and leading research projects, maintaining project objectives for research studies, liaising with research organizations and service providers to identify and coordinate study requirements, and supporting financial oversight of clinical research studies. The PM assists with the adoption and on-going sustainment of RealTime Clinical Trial Management System information by identifying, formalizing and implementing associated best practices; builds the study structure and its modules in the CTMS; monitors clinical trial and clinical research activities; makes recommendations regarding quality assurance and efficiency to site leadership; provides training, education and operational support; facilitates communication; collaborates and exchanges knowledge associated with CTMS and its modules.

Duties/Accountabilities:

• Consults with Principal Investigators, Research Managers and other partners to determine opportunities for new initiatives. Identifies, researches and analyzes information to achieve research project objectives.  Assists in writing and/or editing significant portions of documentation in support of research projects and activities. 
• Facilitates the development, maintenance and enhancement of procedures and processes for the operation of clinical trials and research projects.  Provides input to define administrative/ resource needs and develops and implements strategies to meet needs.  Monitors financial resources and supports accounting processes including reporting on variances. Provides professional expertise to clinical trial and research personnel by establishing clear definitions of responsibility for each employee as it relates to the CTMS and provides training and administrative support to meet operational requirements. 
• Contributes to research design, development of research tools, including the study database, and follow-up activities.  Monitors progress of clinical trials and research projects and attainment of project milestones.  Prepares and distributes reports, including reports to Managers and funding agencies.  Coordinates the development of study documents, tools and processes in collaboration with Principal Investigators and research teams.
• Liaises with Clinical Research Managers, Investigators, nurses, coordinators, finance, and budget personnel to simplify clinical research processes and maximize cost-recovery through CTMS customization and process optimization. Assists in the development of training materials, processes, policies and forms to manage clinical research using the CTMS. Leverages knowledge from established clinical research teams to improve research processes for developing research groups.
• Performs other related duties as assigned.

 

Qualifications:

• A level of education, training, and experience equivalent to a Bachelor’s Degree in Health Sciences or related field, plus five (5) years of recent related research experience in the health care sector including experience using data analysis programs and software platforms such as RealTime CTMS and REDCap.
• Certification such as Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA), or Clinical Research Associate/Coordinator Certification preferred.
• Sound understanding of clinical trials and research processes.  
• Extensive knowledge of the scientific terminology and research methodology in the health sector.  
• Ability to evaluate service delivery.  
• Excellent interpersonal, management, coordination and communication skills.  
• Proven leadership skills and team/collaborative skills, especially within a research infrastructure.  
• Strong problem-solving abilities.    
• Ability to make oral and written presentations.  
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Power BI and Visio.   
• Knowledge of Tri-Council Policy Statement (TCPS2) Research Ethics, Health Canada, FDA and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) regulations and guidelines.