Clinical Research Associate II (SRI) - Odette Cancer Centre Clinical Trials -

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 Clinical Trials 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 GU Med 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 II will report to the team Physician Site Lead, team Supervisor, and PIs. The CRA II may also work closely with an interdisciplinary team including the Clinical Trials Manager, Operation Leads, and all other OCC Clinical Research Program staff.

Primary responsibilities include but are not limited to:

• Independently lead the management of several complex Health Canada-regulated interventional clinical trials, academic clinical trials, and other research projects
• Requesting, handling, and/or processing laboratory specimens (blood, urine, tissue)
• 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
• Communication with various hospitals and health service facilities to obtain medical information
• Understanding requirements of the ethics review process, completing REB submissions and documentation updates
• Data entry and resolving sponsor queries
• Scheduling and participating in monitoring visits, sponsor audit visits, regulatory inspections
• Maintaining documentation as part of the trial master file, creating source documents
• Communication with internal hospital departments or liaising with Contract Research Organizations (CROs) and Sponsors/Trial Lead hospitals on behalf of your principal investigators
• Tracking of trial metrics, and other research-related activities within the needs of the team
• Leading the activation activities of new clinical trials with external sponsors and CROs, and the closure of completed trials

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 3-5 years of related professional or practical experience, including at least 3 years in clinical research, or the equivalent combination of education and professional experience; Health Canada-regulated clinical trial experience preferred
• SoCRA/CCRP certification an asset; oncology clinical trial experience 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 and experience in the ethics review and submission 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
• Experience or familiarity with research contracts and budget management an asset
• May be involved in training new team members or assisting junior staff on team

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 complex problem solving independently
• Reliable attendance and punctuality
• Strong accountability for independent workload; maintain multiple projects with minimal direct supervision; develop and maintain tools or trackers to enhance task performance
• Demonstrated professional behaviours and ethical integrity
• Strong cultural competency and ability to work respectfully in diverse team environments

Interested candidates please apply online and complete all screening questions in the online portal.

Last day for applications: Until Filled