Ethics and Regulatory Clinical Research Associate

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 Children’s 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 incumbent’s 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 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

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 one’s own

• Demonstrates a commitment to enhancing one’s 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.