Description
Type: Staff - Non Union
Job catetogry:M&P - AAPS
Job profile: AAPS Salaried - Educational Programming, Level A
Job title: Clinical Research Coordinator & Quality Lead
Department: Michael Cuccione Childhood Cancer Research Program | Department of Paediatrics
Compensation range: $5,365.42 - $7,709.92 CAD Monthly
The Compensation Range is the span between the minimum and maximum base salary for a position. The midpoint of the range is approximately halfway between the minimum and the maximum and represents an employee that possesses full job knowledge, qualifications and experience for the position. In the normal course, employees will be hired, transferred or promoted between the minimum and midpoint of the salary range for a job.
Reference: JR17959
Job End Date: December 31, 2025
Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.
This offer is conditional upon successful completion of a Criminal Record Check.
This position is located within a health-care facility. Therefore, this position requires successful verification of full vaccination against Covid-19 provided prior to the start date, as required by the provincial health mandate.
Note: Only the Full Time Compensation Range is displayed on the job posting details advertised on the UBC Career sites.
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
Acting as the Quality Lead & Clinical Research Coordinator (CRC), within the Division of Pediatric Hematology/Oncology/BMT, the individual will manage complex clinical trials as well as lead Quality initiatives through quality improvement, quality assurance/control, and quality planning. The incumbent works collaboratively with the CTU Manager, Team Leads and with cross-functional teams to resolve quality issues and optimize trial processes. The successful candidate’s expertise will contribute to the successful execution of clinical trials, through supporting continuous improvement in integrity of data and patient safety.
The incumbent works with physicians and staff in the CRA office and Oncology clinic. Office is located in the Shaughnessy Building.
The MC3RP program supports approximately 100 active clinical research studies for children and young adults in British Columbia with cancer and blood disorders. These studies include, but are not limited to, research on active treatment, supportive care, and the long-term effects of cancer related illnesses, cellular transplant, and blood disorders therapy. The MC3RP has a number of research affiliations that include CureWorks, Transplantation and Cellular Therapeutics (TRACE), Pediatric Cancer Immunotherapy Trials Network (PedCITN), The Blood and Marrow Transplant Clinical Trials Network (BMT CTN), Industry Sponsors, Primary Immune Deficiency Treatment Consortium (PIDTC) Children's Oncology Group, the C17 Council for Childhood Cancers and Blood Disorders, Precision Oncology For Young people (PROFYLE), Canadian Cancer Trials Group (CCTG), Pediatric Blood and Marrow Transplant Consortium (PBMTC), Centre for International Blood and Marrow Transplant Research (CIBMTR), Canadian Bone Marrow Transplantation Group (CBMTG) as well as investigator-initiated research. Expansion beyond the existing relationships is ongoing.
The incumbent is required to conduct all research activities in an ethical manner, suited to the regulations of the University of British Columbia and to the professional organizations governing his or herself and those governing the activities of the institution and all other investigators. Strict confidentiality of all study matters must be adhered to. The incumbent's research activities are accountable to the study Principal Investigator, the Director of the MC3RP, and the candidate's governing professional organization.
Organizational Status
The incumbent will report directly to the CTU Manager and Team Lead. The incumbent will also report to and/or receive direction from the divisional Principal Investigators, Research Services Manager and the Director of Research. The incumbent's office is located in the Shaughnessy Building.
Work Performed
Quality Lead
Planning and delivery of CANTRAIN clinical trial training programs/streams and capacity building initiatives to frontline learners and practitioners (50%).
- Develops training plans and timelines to align with Good Clinical Practice (GCP) guidelines and evaluates ongoing training and education.
- Develops and maintains a quality improvement system within clinical research.
- Adheres to applicable regulatory requirements and Quality best practices.
- Gathers metrics related to quality improvement. Extracts data and analyzes results, trends in variances and Corrective & Preventative Action (CAPA) plans.
- Prepares and implements relevant methodologies, procedures, and tools.
- Advises the CTU Manager on quality improvement strategies within work systems.
- Involved in monitoring of clinical trials to ensure quality control.
- Performs routine quality reviews.
- Highly involved in preparation for audits and inspections.
- Undertakes projects and duties as assigned by the CTU Manager.
- Ensures policies, internal work instructions, and relevant guidelines are reviewed periodically and advises on updates as required.
- Attends relevant meetings to define strategy, goals and scope of Quality related projects.
- Performs other related tasks as required.
Study conduct
- Reviews protocols and provides input on resource allocation and feasibility.
- Ensures clinical trials are conducted according to ethical guidelines and GCP standards.
- Upkeep of study participant tracking.
- Verifies eligibility, enrolls pediatric patients in trials, and manages data collection, submission, and creation of research charts.
- Oversees study logistics and advises study Clinical Research Associates (CRAs) on study-related issues.
- Collaborates with Research Nursing staff to ensure study tasks, including adverse event reporting, are completed per protocol.
- Regularly reports on study activities and concerns to the Team Lead and other relevant personnel.
- Communicates with study sponsors and prepares for audits and monitoring visits, addressing auditor questions, and developing corrective and preventative action plans.
- Coordinates with healthcare teams and other research personnel both on-site and off-site for project management and information exchange.
- Performs other related tasks as required.
Consequence of Error/Judgement
Exercises a considerable amount of judgment, responsibility, and initiative in determining work procedures and methods of the staff. The incumbent is required to conduct all research activities in an ethical manner, suited to the proper activities of the University of British Columbia and to the professional organizations governing his or herself and those governing the activities of the institution and all other investigators. Any procedures or data recorded as part of a trial must be accurate and must accurately reflect the work performed. Strict confidentiality of all study participants must be adhered to. All activities involving participants are accountable to the Principal Investigator, the Department Head, and the candidate's governing professional organization.
Consequences of error are high and this is a position with significant responsibility as these clinical trials impact patient treatment. The Quality initiatives impact institutional reputation of the program, and direction of future studies. Errors could jeopardize the study treatment options for patients and reputation for collaborative participation with industry, government and other centers.
Supervision Received
The Quality Lead & CRC will receive supervision and direction from CTU Manager and Team Lead. It is expected to demonstrate the ability to work independently. The incumbent will be required to problem solve on a continual basis. The overall supervision of the MC3RP program is headed by the MC3RP director who is responsible to the Hematology/Oncology/BMT Division Head and Executive Director of the BCCHRI.
Supervision Given
The incumbent will demonstrate the ability to work independently and advise study CRAs as needed.
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
If not already obtained, the division will support training for clinical research professional certification through the Society of Clinical Research Associates (SoCRA).
Assets:
- Demonstrated knowledge and experience with Pediatric Oncology, BMT and Cellular Therapeutics
- Knowledge of Quality principles
- Attentive to detail, with the ability to work accurately and quickly
- High degree of computer literacy including familiarity with Microsoft Word and Excel
- Ability to learn new software programs
- Excellent organizational and interpersonal skills
- Ability to prioritize and work effectively under pressure to meet deadlines
- Ability to exercise initiative and maintain confidentiality
- Effective communication, both orally and in writing
- Ability to work both independently and within a team environment
- Physical ability to do the job