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Ethics and Regulatory Clinical Research Associate

3 months ago

Vancouver, Canada UBC Full time

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 (CRA) for the Michael Cuccione Childhood Cancer Research Program (MC3RP)

Department
Michael Cuccione Childhood Cancer Research Program | Department of Paediatrics

Compensation Range
$4,434.02 - $5,228.81 CAD Monthly

Posting End Date
June 28, 2024

**Note**: Applications will be accepted until 11:59 PM on the Posting End Date.

Job End Date

Jun 30, 2025

This offer is conditional upon successful completion of a Criminal Record Check.

**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

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 Children's and Women's 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 Children's and Women's Health Centre of BC Campus.

Work Performed

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