Clinical Research Associate I

3 weeks ago

Toronto, Canada Sunnybrook Health Sciences Centre Full time

**Clinical Research Associate I; Sunnybrook Research Institute, Odette Cancer Centre Clinical Trials**

**Regular Full-time Position**

**Sunnybrook Research Institute**

**Fully Affiliated with the University of Toronto**

**Vacancy Exists For: 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, 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 Lung Disease Site Group with the maintenance of several ongoing clinical trials and research studies with a focus on data and 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, 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 and/or processing specimens.

In addition, the CRA I may dedicate part of their time to supporting their research team with other responsibilities such as communication with internal hospital departments, liaising with Contract Research Organizations (CROs) and Sponsors/Trial Lead hospitals to manage the trial master file and applicable documents, 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 Supervisor, Physician Site Lead, PIs, and will also work 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 years clinical and/or professional experience including 1 year clinical research-related experience or equivalent combination of education and experience
- 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

Sunnybrook Research Institute is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for disability during any stage of the recruitment process, please indicate this in your cover letter.

Sunnybrook Research Institute is strongly committed to inclusion and diversity within its community and welcomes all applicants including but not limited to: visible minorities, all religions and ethnicities, persons with disabilities, LGBTQ persons, and all others who may contribute to the further diversification of ideas.

Please be advised that in order to be eligible for employment at Sunnybrook, all new hires must have received the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada (e.g., two doses of a two-dose vaccine series, or one dose of a single-dose vaccine series); **AND** have re

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