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Clinical Research Associate Ii
2 weeks ago
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 55+ 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 Disease Site Groups with the maintenance of several complex ongoing clinical trials with a focus on patient-specific responsibilities. Primary responsibilities include but are not limited to, consenting patients, reviewing trial eligibility criteria; 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, and ECG tests, communication with various hospitals, and health service facilities to obtain medical information; data entry and resolving sponsor queries; completing forms and maintaining supportive documentation; and requesting/processing specimens.
In addition, the CRA II may dedicate part of their time to supporting Protocol Activation activities, complete REB submissions, conduct impact assessment and communication with internal hospital departments, coordinate with the budget coordinator, liaising with Contract Research Organizations (CROs) and Sponsors/Trial Lead hospitals to manage the trial master file and applicable documents, SIV coordination, and other activation-related activities.
The CRA II will be based on-site and will report to the Site Lead and PIs, also working closely with an interdisciplinary team including the Quality Assurance & Education Manager, Operations Assistant Manager, and all other OCC Clinical Research Program staff.
**Qualifications/Skills**:
- Requires the successful minimum completion of a Bachelor’s degree, or recognized equivalent, in a health or science-related discipline with 3-5+ years clinical and/or professional experience including at least 3 years clinical research-related experience or equivalent combination of education and experience
- Oncology clinical trial 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
- Knowledge and experience in the clinical trial protocol activation process, an asset
- Familiarity with the Trial Master File and management of trial-related documents
- Experience preparing and submitting research documents to or working with research ethics boards, an asset
- Excellent oral and written communication skills
- Ability to follow established trial protocols, guidelines, procedures, and standards
- Ability to effectively manage multiple projects with competing deadlines
- Demonstrates excellent team work and efficient independent work habits
- 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
