Summary of Duties and Responsibilities:
The Odette Cancer Center (OCC) Clinical Research program is part of Sunnybrook Research Institute’s (SRI) ongoing commitment to participate in innovative and high quality clinical research.
Within OCC Clinical Research, the Clinical Trials Manager, Operations Team Lead, and Budget & Operations Coordinator, work with 35+ physicians actively participating in clinical research and 55+ OCC clinical research disease site-specific staff. Our program is comprised of 12 disease site groups; Breast, CNS, NETS, GI, GU medical, GU radiation, Gynecology, Head & Neck, Hematology, Lung, Melanoma and Early Phase I-II trials; as well as the pan-Canadian initiative, Canadian Cancer Clinical Trials Network (3CTN).
The goal of this position is to assist the Heme Oncology Disease Site Group with the maintenance of their active oncology clinical research studies, databases, and trials. This position is for a full-time position working weekdays on-site at Sunnybrook, Bayview campus. This position is entitled to health benefits plan, pension, and paid time off/sick days. The CRA I will report to the team Physician Site Lead, team Supervisor, and PIs. The CRA I may also work closely with an interdisciplinary team including the Clinical Trials Manager, Operations Manager, and all other OCC Clinical Research Program staff.
Primary responsibilities include but are not limited to:
- Maintaining documentation as part of the trial master file, creating source documents
- Consenting patients, reviewing trial eligibility criteria and medical records
- Applying clinical trial protocol requirements into patient & data activities such as documenting medical history, medications and adverse events from patients; reporting Serious Adverse Events
- Scheduling and conducting patient appointments, completing qualify of life questionnaires with patients
- Conducting measurements on patients including vital signs, ECGs, height/weight measurements
- Requesting, handling, and/or processing laboratory specimens (blood, urine, tissue)
- Data entry and resolving sponsor queries
- Communication with various hospitals and health service facilities to obtain medical information
- Understanding requirements of ethics review process and supporting in submissions and documentation updates
- Scheduling and participating in monitoring visits, sponsor audit visits
- Communication with internal hospital departments or liaising with Contract Research Organizations (CROs) and Sponsors/Trial Lead hospitals
- Tracking of trial metrics, and other research-related activities within the needs of the team
- Supporting the activation activities of new clinical trials and the closure of completed trials
The successful candidate will be an eager team player who meets the following qualifications/skills:
