Clinical Research Associate I (SRI) - Odette Cancer Centre Clinical Trials - Regular Full-time

Summary of Duties and Responsibilities:
The Odette Cancer Center (OCC) Clinical Research program is part of Sunnybrook Research Institutes (SRI) ongoing commitment to participate in innovative and high quality clinical research.

Within OCC Clinical Research the Research and Medical Directors Clinical Trials Manager Operations 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 our Hematology Oncology Disease Site Group with the maintenance of several ongoing research studies with a focus on data documentation sample processing and patient-specific responsibilities. This is an on-site position Monday-Friday at Sunnybrook Bayview campus.

Primary responsibilities include but are not limited to:
Consenting patients reviewing trial eligibility criteria and medical records
Review ongoing patient protocol requirements/ adherence
Reporting Adverse Events/Serious Adverse Events
Scheduling patient appointments & completing qualify of life questionnaires 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
Scheduling and participating in monitoring visits
Maintaining documentation as part of the trial master file
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
Requesting handling and/or processing laboratory specimens (blood urine tissue)

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 Clinical Trials Manager Operations Manager and all other OCC Clinical Research Program staff.

The successful candidate will be an eager team player who meets the following qualifications/skills:
Requires the successful minimum completion of a Bachelors degree or recognized equivalent in a health or science-related discipline with 2-3 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
Oncology patient experience preferred
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 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
Acceptable attendance