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

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 Clinical Trials Manager Operations 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 12 disease site groups; Breast CNS NETS GI GU medical GU radiation Gynecology Head & Neck Hematology Lung Melanoma and Early Phase I-II trials; as well as the pan-Canadian initiative Canadian Cancer Clinical Trials Network (3CTN).

The goal of this position is to assist the Hematology Oncology Disease Site Group with the maintenance of their active oncology clinical research studies databases and trials. This position is for a full-time position working weekdays on-site at Sunnybrook Bayview campus. This position is entitled to health benefits plan pension and paid time off/sick days. The CRA I 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.

Primary responsibilities include but are not limited to:

• Consenting patients reviewing trial eligibility criteria and medical records
• Applying clinical trial protocol requirements into patient & data activities such as documenting medical history medications and adverse events from patients; reporting Serious Adverse Events
• Scheduling and conducting patient appointments completing qualify of life questionnaires with patients
• Conducting measurements on patients including vital signs ECGs height/weight measurements
• Requesting handling and/or processing laboratory specimens (blood urine tissue)
• Data entry and resolving sponsor queries
• Supporting the activation activities of new clinical trials and the closure of completed trials
• Understanding requirements of ethics review process and supporting in submissions and documentation updates
• Communication with various hospitals and health service facilities to obtain medical information
• Maintaining documentation as part of the trial master file creating source documents
• Scheduling and participating in monitoring visits sponsor audit visits
• Communication with internal hospital departments or liaising with Contract Research Organizations (CROs) and Sponsors/Trial Lead hospitals
• Tracking trial metrics and other research-related activities within the needs of the team

The successful candidate will be an eager team player who meets the following qualifications/skills:

Research Qualifications/Skills:

• Requires the successful minimum completion of a Community College Diploma/Certificate or University Degree in a health related discipline
• A minimum of 2-3 years of related professional or practical experience including at least 1 year in clinical research or the equivalent combination of education and professional experience; Health Canada-regulated oncology clinical trial experience an asset
• SoCRA/CCRP certification an asset
• In-depth knowledge of ICH guidelines Good Clinical Practice and transportation of dangerous goods
• Proven experience in processing and shipping blood samples
• Experience in the informed consent process and working directly with research participants
• Ability to understand and apply clinical trial protocols and laboratory manuals
• Knowledge of the ethics review process
• Strong working capability of MS Office and ability to quickly adapt to new online systems and applications accurately entering data and resolving queries (EDC databases document portals)
• Experience maintaining clinical trial documentation in a Trial Master File creating source documentation
• Experience in patient-facing communication including obtaining AE/SAE or other trial-related medical information
• Familiarity with medical terminology or experience reviewing patient health records

Interpersonal Qualifications/Skills:

• Well-developed organizational and time management skills
• Excellent team work with a strong can-do attitude to build working relationships
• Excellent oral and written communication skills; using professional communication tactics across multidisciplinary teams and external stakeholders
• Ability to follow verbal instruction written procedures and apply trainings in practice
• Demonstrated accurate and efficient work habits with close attention to detail and high quality of work
• Strong analytical skills and ability to apply critical thinking for problem solving
• Reliable attendance and punctuality
• Strong accountability for independent workload
• Demonstrated professional behaviours and ethical integrity
• Strong cultural competency and ability to work respectfully in diverse team environments