Job Description

Staff - Non Union
Job Category Non Union Technicians and Research Assistants
Job Profile Non Union Salaried - Research Assistant /Technician 3
Job Title Ethics and Regulatory Clinical Research Associate (Hem/Onc/BMT)-2
Department Michael Cuccione Childhood Cancer Research Program | Department of Paediatrics
Compensation Range $4,434.02 - $5,228.81 CAD Monthly
Posting End Date May 31, 2024
Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.
Job End Date Jun 30, 2025
This offer is conditional upon successful completion of a Criminal Record Check.
This position is located within a health-care facility, therefore, the successful candidate will be required to provide verification of full vaccination against Covid-19 provided prior to the start date, as required by a provincial health mandate.
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
This position is responsible for activities involved in UBC.CW Research Ethics Board (REB) applications for clinical research protocols conducted by the Michael Cuccione Childhood Cancer Research Program (MC3RP) within the Children's and Women's Health Centre of BC's Division of Hematology/Oncology/Bone Marrow Transplant (Hem/Onc/BMT) and the BC Children's Hospital Research Institute. The MC3RP supports approximately 100 active clinical research studies for children 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 and blood disorders therapy. The CCBR has a number of research affiliations that include the Childrens Oncology Group, Industry Sponsors, the C17 Childhood Cancers and Blood Disorders, PRecision Oncology For Young peopLE (PROFYLE,) National Cancer Institute of Canada (NCIC), Pediatric Cancer Immunotherapy Trials Network (PedCITN), 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 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 undertaken as part of a trial must be accurate and must accurately reflect the work performed. Strict confidentiality of all study matters must be adhered to. The incumbents research activities are accountable to the Principal Investigator, the Division Head of Hematology/Oncology/Bone Marrow Transplant, and the candidate's governing professional organization.
Organizational Status
The incumbent will report to and receive direction from the Research Services Manager, the divisional Principal Investigators of each project, and the Director of Research. The RT3 works collaboratively and closely with the CTU Manager and Research Services Manager. This position requires working both independently and in cooperation with hospital physicians, residents, nurses, research staff, pharmacy, and laboratory staff at Childrens and Womens Health Centre and the BC Cancer Agency. The incumbent will collaborate and work with representatives of industry and external staff at participating organizations, hospitals and collaborating laboratories located at different sites nationally and internationally. Both CTU and Research Services Managers are under the supervision of the Division Head and Research Director, respectively. This position is hybrid, with a mix of remote and on-site work. The touchdown space/shared office is located in the BCCHRI of Childrens and Womens Health Centre of BC Campus.
Work Performed
To coordinate the activities involved in UBC CW Research Ethics Board (REB) applications for clinical research protocols, including but not limited to Phases I, II and III chemotherapy studies, hematology studies, bone marrow transplant studies, supportive care studies and ancillary studies for the Childhood Cancer and Blood Research Program:
Ensuring adherence to UBC CW REB Guidelines
Work closely with study Principal Investigators (PI), both internal and external, on study start-up activities
Responsible for the creation of study specific consents, assents and other required study documents
Responsible for timely ethics submissions of studies utilizing the Researcher Information Services (RISe) database
Responsible for the timely RISe submission of amendments, Requests for Acknowledgement (RFA) and study closures
Working closely with the identified individuals to obtain departmental sign-off for associated protocol activities
Responsible for maintaining REB records and associated documents to ensure that study investigator binders and Central Binder folders are accurately maintained
Responsible for the activities surrounding site selection (i.e. corresponding with sponsor/sponsors representatives, setting and confirming site selection agendas, touring identified departments with the sponsors representatives, following up on questions generated from the visit)
Set up for, attend and complete summary documents for the Research Oversight (ROC) and Phase I.II Developmental Therapeutics (DVL) Committee meetings where proposed study protocols are discussed.
Provide feedback on proposed study protocol issues at the time of the review
Liaise with the University/Industry Liaison Office (UILO) and BCCH Research Institute Finance Manager on contract related start-up issues
Liaise with the CTU Manager and assigned Study CRA for operational handover
Completion, updating and submission of existing study regulatory documents to sponsors/CROs/Health Canada and other regulatory bodies as required by Good Clinical Practice standards
Responsible for archiving of closed clinical research projects
Maintenance of his/her own clinical research education and regulatory certification as mandated by the Division
Preparing and participating in audits and study monitoring visits from regulatory bodies
Providing back-up for other Division REB personnel while sick or on holidays
Attending conferences and meetings, possibly involving travel
If not already obtained, the division will support training for clinical research professional certification through the Society of Clinical Research Associates (SoCRA) or
Performing other related tasks and projects as deemed necessary
Consequence of Error/Judgement
Consequences of error are high and this is a position with significant responsibility. The activities described above impact the direction of Division program objectives. Errors could impact upon the reputation of the program as a whole and jeopardize the options for collaborative participation with industry, government and other centers.
Supervision Received
It is expected that the RT3 will demonstrate the ability to work independently once training has been successfully completed. The RT3 will be required to problem solve on a continual basis.
Supervision Given
The RT3 will receive supervision and direction from the Clinical Research Services Manager.
Minimum Qualifications
Completion of a relevant technical program or a university degree in a relevant discipline and a minimum three years of related experience or an equivalent combination of education and experience.
Willingness to respect diverse perspectives, including perspectives in conflict with ones own
Demonstrates a commitment to enhancing ones own awareness, knowledge, and skills related to equity, diversity, and inclusion
Preferred Qualifications
Knowledge of medical terminology. Knowledge of ethical principles and research applications. Demonstrated knowledge and experience with Pediatric oncology. Familiarity with database management programs. Attentive to detail, with the ability to work quickly and accurately. High degree of computer literacy including familiarity with Microsoft Word, Excel, Teams. Ability to learn new software programs list collaborative task managers. Excellent organizational and interpersonal skills a must. 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 in the office and at home. Physical ability to do the job.