Staff - Non Union
Job Category
M&P - AAPS
Job Title
Clinical Research Manager
Department
HLI Clinical Research Core | UBC James Hogg Research Centre | Faculty of Medicine (Shelly Keidar)
Posting End Date
June 15, 2025
Note:Applications will be accepted until 11:59 PM on the Posting End Date.
Job End Date
Jul 31, 2026
At UBC, we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research, innovation, and learning for all faculty, staff and students. Our commitment to employment equity helps achieve inclusion and fairness, brings rich diversity to UBC as a workplace, and creates the necessary conditions for a rewarding career.
Job Summary
The Clinical Research Manager (CRM) is responsible for managing research activities of multiple clinical studies and trials at the Centre for Heart Lung Innovation (HLI) located at St. Paul’s Hospital in downtown Vancouver. The CRM's will be responsible for regulatory and operational preparations and administration of clinical studies and will manage several research coordinators executing the research activities in accordance with study protocols within an allocated budget and timelines. The CRM will liaise with clinical and hospital staff to ensure the successful achievement of study goals and milestones while maintaining high security, privacy, and ethical practices.
Organizational Status
The CRM will report directly to the Clinical Research Services Core Manager and receive supervision from Principal Investigator(s). The CRM will work collaboratively with professional staff (nurses, physicians, technicians) and supervise research coordinators, assistants, and students.
The UBC Centre for Heart Lung Innovation at St. Paul’s Hospital brings together basic and clinical scientists in an exciting multidisciplinary environment to address heart, lung, and critical care disease. The HLI is the largest translational research centre within Providence Health Care’s St. Paul’s Hospital, comprised of 50 Principal Investigators (PIs), of whom approximately 40% conduct clinical research, and over 300 Scientists and staff. Education is provided to over 130 undergraduate, graduate, and postgraduate students.
Work Performed
- Facilitate the transition of a large-scale clinical registry into an electronic data capture system, create new Standard Operating Procedures (SOPs), and manage access to the data.
- Lead patient engagement in governing the above-mentioned registry transition and management.
- Develop work priorities for the research project team, manage workload, establish timelines, and ensure research objectives and deadlines are met.
- Liaise with physicians and other hospital staff to establish and coordinate study operations within hospital departments, including laboratories, radiology, IT, and outpatient services.
- Prepare ethics and regulatory (Health Canada) applications, amendments, and renewals, maintain trial binders, manage regulatory meetings, and draft annual reports. Meet with Pharma Study Monitors and lead Health Canada audits.
- Develop and regularly update organizational and study-specific Standard Operating Procedures (SOPs) to ensure compliance with ICH/GCP guidelines and clinical operations.
- Manage and facilitate research projects across other Canadian and International sites. Ensure site-specific needs are met to comply with ICH/GCP guidelines.
- Manage budgets and organize investigator meetings.
- Contribute to the development of investigator-led and clinical trial project protocols.
- Develop and oversee patient enrollment strategies.
- Review study progress with the study team and initiate necessary actions to improve progress if needed.
- Maintain the accuracy, accessibility, and confidentiality of study records and reports. Manage and implement quality assurance strategies. Maintain accurate and timely data collection and handling of subject records by research coordinators, including audit processes, education, and training of study personnel and trainees.
- Execute queries and conduct preliminary data analysis on study database(s).
- Assist the Core Manager in hiring, training, and supervising new research staff.
- Lead study team meetings. Establish effective communication with all team members and ensure timely notification of adverse events and other issues to the Core Manager and the appropriate and regulatory authorities.
- Contribute to academic publications and present at academic conferences.
- Perform other duties as needed.
Consequence of Error/Judgement
This position exercises professional judgement and initiative in managing various research activities with a high level of independence. Failure to act professionally and tactfully would harm patients and various UBC and healthcare departments. Poor judgment or errors and failure to follow protocols, guidelines, and policies could seriously compromise the quality of the research and result in delays in completing projects.
Inability to complete work at a high level of accuracy and efficiency may adversely affect the quality and significance of the research and the reputation of the PIs. Activities such as database documentation of maintenance and access, research, and support for both internal and external researchers are all critically dependent on the security and privacy of information systems that have been developed and are maintained. Any breach in confidentiality or data security would place the future of the research projects at risk. Inadequate documentation, organization, communication, and planning may adversely affect the credibility and ability to secure future funding of investigators, staff, and trainees.
Supervision Received
The CRM works independently and reports directly to the Clinical Research Services Core Manager. It receives supervision from the Principal Investigator(s). The CRM will collaborate with professional staff (nurses, physicians, technicians).
Supervision Given
The CRM will supervise research coordinators, assistants, and students.
Minimum Qualifications
Undergraduate degree in a relevant discipline. Minimum of two years of related experience, or an equivalent combination of education and experience.
- Willingness to respect diverse perspectives, including perspectives in conflict with one’s own
- Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion
Preferred Qualifications
- Experience in clinical research in a hospital, academic setting, research environment, healthcare organization, or related industry is preferred.
- Proven experience in clinical trials and complying with ICH/GCP regulations.
- Knowledge of quantitative research methods, implementation, and outcome assessment applicable to health and/or partnered research.
- Experience with large-scale clinical data systems is an asset.
- Experience with Patient and Public Involvement and Engagement in research approaches is an asset.
- Demonstrated data analytics and statistical interpretation skills.
- Sound knowledge of medical, clinical, and research terminology.
- Excellent computer skills (MS Office).
- Demonstrated ability to think critically and respond in a broad range of activities with high independence.
- Exceptional organizational skills and demonstrated ability to maintain high accuracy and attention to detail efficiently.
- Excellent interpersonal skills and the ability to act tactfully and respectfully with people from diverse personality types and socioeconomic backgrounds.
- Demonstrated effective oral and written communication skills.
- Ability to exercise sound judgment, work under pressure, prioritize workload, and meet deadlines.
- High intrinsic motivation and the ability to be self-directed and work independently and within a team environment.
- Demonstrated initiative and the willingness to work closely with team members to resolve problems quickly and appropriately.
- Willingness to respect diverse perspectives, including perspectives in conflict with one’s own
- Demonstrates a commitment to enhancing one’s awareness, knowledge, and skills related to equity, diversity, and inclusion.
- Able to occasionally work flexible hours (mornings/evenings) due to research activities’ schedule, such as sample collection procedures or focus groups.