Clinical Research Associate Ii

2 weeks ago

Toronto, Canada Sunnybrook Health Sciences Centre Full time

**Clinical Research Associate II; Sunnybrook Research Institute, Clinical Trials, PMT Initiative**

**Regular Full-time**

**Sunnybrook Research Institute**

**Fully Affiliated with the University of Toronto**

**Vacancy Exists For: Clinical Research Associate II**

**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 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 2 pan-Canadian initiatives: Personalize My Treatment (PMT) & The Canadian Cancer Clinical Trials Network (3CTN).

The Personalize My Treatment (PMT) initiative is seeking an experienced and highly motivated individual to work as a Clinical Research Associate (CRA) II on all aspects of Phase I, II and III clinical trials. The CRA II will report to the Principal Investigator(s) and be responsible for activating new clinical trials and for the maintenance of several complex ongoing clinical trials with a strong 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, liaising with internal departments, research collaborators, ethics boards, and industry sponsors; data entry and resolving sponsor queries; completing forms and maintaining supportive documentation; and requesting/processing specimens.

The CRA II may dedicate part of their time to supporting Protocol Activation activities, completing REB submissions, conducting impact assessments with internal hospital departments, coordinating with the budget coordinator, liaising with legal teams, Contract Research Organizations (CROs), and Sponsor organizations to manage the trial master documents, SIV coordination, and other activation-related activities. The CRA II may also support PIs in organizing and facilitating meetings, or other research-related activities as necessary within the role.

The CRA II will be based on-site and will report to the PMT Site Lead and PIs of each trial, 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
- At least 3 years of site-level interventional clinical trial-related experience or equivalent combination of education and experience
- Oncology clinical trial experience a strong asset
- SoCRA/CCRP certification, preferred
- 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 site clinical trial protocol activation process
- 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
- 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 interventional clinical trials

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 Institu

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