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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 Research and Medical Directors, Quality Assurance and Education Manager, Operations Assistant Manager and Budget & Operations Coordinator, work with 35+ physicians actively participating in clinical research and 45+ OCC clinical research disease site-specific staff. Our program is comprised of 10 disease site groups; Breast, CNS/NETs, GI, GU, Gynecology, Head & Neck, Hematology, Lung, and Melanoma, in addition to Personalized Medicine.
The goal of this position is to assist one of our Breast Oncology Disease Site Group with the maintenance of several ongoing clinical trials or research studies with a focus on data, documentation, and patient-specific responsibilities.
Primary responsibilities include but are not limited to:
- Consenting patients, reviewing trial eligibility criteria and medical records
- Ongoing patient protocol requirements
- Reporting Adverse Events/Serious Adverse Events
- Scheduling patient appointments, communicating with patients,
- Conducting measurements on patients including vital signs, height/weight measurements
- Communication with various hospitals and health service facilities to obtain medical information
- Data entry and resolving sponsor queries, participating in monitoring visits
- Completing trial-related forms and maintaining documentation as part of the trial master file
- Requesting, handling, and/or processing laboratory specimens (blood, urine, tissue)
- 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
- Support activation of new clinical trials
- Manage, submit, review research ethics board submissions or other regulatory documents
The CRA I will be based on-site and 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 Quality Assurance & Education Manager, Operations Assistant Manager, and all other OCC Clinical Research Program staff.
The successful candidate will be an eager team player who meets the following qualifications/skills:
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- Requires the successful minimum completion of a Bachelor’s degree, or recognized equivalent, in a health or science-related discipline with 3 years clinical and/or professional experience including 1 year clinical research-related experience or equivalent combination of education and experience; oncology research experience an asset
- SoCRA/CCRP certification an asset
- Well-developed organizational and time management skills
- In-depth knowledge of ICH guidelines and Good Clinical Practice
- Proven experience in processing and shipping blood samples
- Familiarity with the Trial Master File and management of trial-related documents
- Ability to follow established trial protocols, guidelines, procedures, and standards
- Ability to effectively manage multiple projects with competing deadlines
- Excellent oral and written communication skills
- Demonstrates excellent team work and efficient independent work habits
- Proven experience taking initiatives and a strong customer service “can-do” attitude
- Strong analytical skills with close attention to detail
- Experience in data collection, data entry, and query resolution using electronic data capture systems
- Working knowledge of word processing, spreadsheet and database software packages such as MSOffice
- Familiarity with medical terminology and patient-facing communication, including obtaining AE/SAE or other trial-related medical information
- Familiarity with the informed consent process and experience consenting patients to clinical trials or research studies
Application screening will continue until a suitable candidate is identified. If your expertise qualifies you for this challenging full-time position, please apply below.
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