Clinical Research Associate (Hem/Onc/BMT)

University of British Columbia - University of British Columbia (Vancouver campus), BC (il y a 30+ jours)

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Staff - Non Union

Job Category
Non Union Technicians and Research Assistants

Job Profile
Non Union Salaried - Research Assistant /Technician 3

Job Title
Clinical Research Associate (Hem/Onc/BMT)

Department
Schultz Laboratory | Department of Paediatrics | Faculty of Medicine

Compensation Range
$3,905 - $4,612 CAD Monthly

Posting End Date
February 3, 2021

Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.

Job End Date

Feb 14, 2022

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

JOB TITLE

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

JOB SUMMARY

This position is responsible for coordinating 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 around 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 MC3RP has a number of research affiliations that include the Children’s Oncology Group, Industry Sponsors, the C17 Childhood Cancers and Blood Disorders, National Cancer Institute of Canada (NCIC), Precision Oncology For Young people (PROFYLE), Canadian Cancer Trials Group (CCTG), Pediatric Blood and Marrow Transplant Consortium (PBMTC), Pediatric Cancer Immunotherapy Trials Network (PedCITN), Centre for International Blood and Marrow Transplant Research (CIBMTR), Canadian Bone Marrow Transplantation Group (CBMTG) as well as investigator-initiated research.

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 Division Head of Hematology/Oncology/Bone Marrow Transplant, and the candidate's governing professional organization.

ORGANIZATIONAL STATUS

The Research Technician (RT3) will report directly to the Clinical Trials Unit Manager (CTU Manager) who is under the supervision of the Division Head and Research Director, respectively. The incumbent will also report to and receive direction from the Principal Investigator of each assigned project.

The RT3 works with physicians and staff at BC Children’s Hospital in the Hem/Onc/BMT clinical research office with nine other CRAs. Coordination within the Hematology/Oncology/BMT Outpatient Clinic and Inpatient Ward, as well as outside physician offices is essential in order to complete study requirements and obtain the information for data submission. The RT3's office is located in B315 of the Shaughnessy Building.

WORK PERFORMED

To coordinate 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::

  • Ensuring adherence to and maintenance of protocols
  • Maintaining protocols and associated documents to ensure they are up-to date
  • Responsible for the day-to-day operation of multi-site investigator initiated project
  • Working closely with the clinical research staff
  • Identifying potential study participants
  • Reviewing and confirming eligibility criteria
  • Registration of patients on clinical studies
  • Creation of study specific documents
  • Accurate and timely completion and submission of paper and electronic data capture forms
  • Creating and maintaining research charts on registered subjects
  • Reporting adverse drug reactions in consultation with physician and in accordance with protocol-specific guidelines
  • Procuring and safely shipping as well as maintaining accurate documentation of study specimens from
various sources according to protocol guidelines and federal regulations
  • Acting as liaison with health care team and laboratory team, both on-site and outside the institution, for
project management and information exchange regarding clinical studies
  • Performing data entry and managing research databases with accuracy
  • Preparing and participating in audits and study monitoring visits from various regulatory bodies
  • Attending conferences and meetings, possibly involving travel
  • Timely completion of required regulatory certificates and tutorials
  • Maintaining clinical research education and regulatory certifications
  • Providing back-up for other team members while sick or on holidays
  • If not already obtained, the division will support training for clinical research professional certification
through the Society of Clinical Research Associates
  • Performing other related tasks and projects as deemed necessary
CONSEQUENCE OF ERROR

Consequences of error are high and this is a position with significant responsibility. The data submitted impacts the direction of future studies. 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 limited basis.

SUPERVISION GIVEN

The RT 3 will receive supervision and direction from the RT 4’s within the Program.

QUALIFICATIONS

Undergraduate degree in a relevant discipline or Graduation from a technical college or institute. Clinical research professional certification through the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP), transportation of Dangerous Goods Certificate preferred. Minimum of 3 years related experience or the equivalent combination of education and experience. Required: Knowledge of medical terminology and patient record systems.

Assets: Demonstrated knowledge and experience with Pediatric oncology, familiarity with database management programs. Knowledge of Good Clinical Practice. Attentive to detail, with the ability to work quickly and accurately. Medium to high degree of computer literacy including familiarity with Microsoft Word, Access and Excel. 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. Communicates effectively both orally and in writing. Ability to learn new software. Ability to work both independently and within a team environment. Physical ability to do the job.