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Staff - Non Union
Non Union Technicians and Research Assistants
Non Union Salaried - Research Assistant /Technician 4
Lead Clinical Research Associate (Hem/Onc/BMT)
Human Resources and Administration | Department of Paediatrics | Faculty of Medicine
$4,558.75 - $5,354.67 CAD Monthly
Posting End Date
December 4, 2021
Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.
Job End Date
Jan 31, 2023
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.
This offer is conditional upon successful completion of a Criminal Record Check.
Lead Clinical Research Associate (CRA) for Cell Therapeutics and Transplantation in the Michael Cuccione Childhood Cancer Research Program.
This position will support clinical trials and research activities 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 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 the 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.
Acting as the Lead Clinical Research Associate (CRA) for the cellular therapeutics and blood and marrow transplantation (BMT) research program, the individual will support the program’s research activities, will be accountable for the development and start-up of clinical protocols within the allocated budget and timelines, and will bring operational knowledge to the translation of clinical research ideas into practice. The individual will be the primary liaison for CureWorks, PedCITN, CBMTG, PIDTC and PBMTC studies, will initiate and manage the execution of clinical trials, and provide support to the entire MC3RP unit.
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 RT4 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.
The RT4’s shared office is located in the BCCHRI of Children’s and Women’s Health Centre of BC Campus.
Manages and coordinates activities involved in UBC.CW Research Ethics Board (REB) applications, assists with contracts and finance, regulatory, departmental approvals, initiation and ethical maintenance of primarily but not limited to cellular therapy and bone marrow transplant clinical research studies with planned expansion into other programs of research within the Michael Cuccione Childhood Cancer Research Program:
- Develops and implements methodologies, policies, procedures and standards. Identifies scope of research.
- Mentors staff (RT3) and may make recommendations with respect to hiring and providing input into staff performance.
- Contributes to the development and finalisation of investigator-initiated protocols.
- Liaises with industry staff for protocol clarification and data management.
- Supervises the pre-site and site initiation and external audit and monitoring of all study activities for assigned protocols. Will be responsible for planning, preparing, participating in, addressing questions, resolving variances and writing summary reports.
- Designs and assists with the management of research budgets as well as cost projections of all study related trials.
- Liaise with funding agencies/foundation to coordinate financial reporting.
- Researches and identifies necessary partnerships with the various departments and individuals.
- Facilitates operational linkages within and among co-investigators, clinic directors, physicians and other health care professionals within the hospital and medical community.
- Oversees training of research personnel to align with GCP (Good Clinical Practice).
- Manages set up of and completes summary documents for the Research Oversight (ROC) and Phase I.II Developmental Therapeutics (DVL) Committee meetings.
- Attends meetings and conferences and performs other related duties.
- Supports clinical research by ensuring protocols will be conducted according to legal and ethical requirements.
- Responsible for the creation of study specific consents, assents and other required study documents.
- Writes, prepares, amends and submits ethics applications and research regulatory documents for specific protocols under the direction of responsible PIs.
- Monitors and assists the accuracy of Informed Consent Documents and related regulatory documents required by Health Canada and the FDA for studies assigned to the group as per protocol. Prepares regulatory documents to be sent to Sponsors.
- Responsible for the activities surrounding the finance and accounting for funded and unfunded research studies liaising with financial officers at both PHSA and UBC.
- Maintains accuracy, accessibility, and confidentiality of research records and reports.
- Maintains competency to assist with the implementation of general technical activities.
- Monitors clinical progress of studies by liaising with study assigned students, RT3s, or Research RNs.
- Organizes and assists with the management of contracts, purchasing of equipment and supplies, and overseeing necessary training for staff.
- Demonstrates communication and general behavior which facilitates positive attitudes toward participation in clinic research.
The RT4 will receive supervision and direction from the Clinical Research and CTU Managers within the Program. It is expected that the incumbent will demonstrate the ability to work independently once initial training has been successfully completed. It is expected, when assessed as performing successfully in the area of study start-up and maintenance, the incumbent will progress to further develop skills and experience in the area of overarching regulatory, contracts and finance matters. The incumbent will be required to problem solve on a continual basis. The overall supervision of the MC3RP is headed by the MC3RP Interim Director who is responsible to the Hematology/Oncology/BMT Division Head and Executive Director of the BCCHRI.
It is expected that the RT4 will demonstrate the ability to work independently and may assist in mentorship of RT3.
CONSEQUENCE OF ERROR/JUDGEMENT
The most important feature of the CTU is that it is essential in its role to provide children and young adults with access to innovative treatment options. The incumbent is expected to exercise a considerable amount of judgment, responsibility, and initiative in determining work procedures and methods. 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 Director of the MC3RP, and the candidate's governing professional organization.
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.
Completion of a university degree in a relevant discipline or technical program and a minimum four years of related experience or an equivalent combination of education and experience. Some positions may require a graduate degree. Experience with the UBC RISe application process or similar on-line applications a must.
- Knowledge of medical terminology
- Knowledge of ethical principles and research applications
Clinical research professional certification through the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP), Good Clinical Practice (GCP) and Health Canada Division 5 certification required. If not already obtained, the division will support training for clinical research professional certification through the Society of Clinical Research Associates (SoCRA).
- 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, Access and Excel
- Ability to learn new software programs and research platforms
- Excellent organizational and interpersonal skills a must
All positions in the Department of Pediatrics at BC Children's Hospital require a Criminal Record Check (CRC). A pre-employment CRC is required as part of the recruitment process and any offer of employment is contingent pending positive results of the CRC.
Equity and diversity are essential to academic excellence. An open and diverse community fosters the inclusion of voices that have been underrepresented or discouraged. We encourage applications from members of groups that have been marginalized on any grounds enumerated under the B.C. Human Rights Code, including sex, sexual orientation, gender identity or expression, racialization, disability, political belief, religion, marital or family status, age, and/or status as a First Nation, Metis, Inuit, or Indigenous person.
All qualified candidates are encouraged to apply; however Canadians and permanent residents will be given priority.