Clinical Research Associate I

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, 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 one of our Gynecology 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:

- Requesting, handling, and/or processing laboratory specimens (blood, urine, tissue)
- Consenting patients, reviewing trial eligibility criteria and medical records
- Ongoing patient protocol requirements
- 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
- 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.
- Requires the successful minimum completion of a Bachelor’s 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