Data Manager (SRI) Odette Cancer Centre Clinical Trials Regular Full-time

Summary of Position:

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 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 Medical 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.

General responsibilities include but are not limited to:

• Assisting in collection of data data entry on electronic data capture systems (EDCs) and databases
• Internal tracking of trial-related data and metrics (patient visits enrollment logs etc)
• Resolving sponsor queries
• Preparing for and participating in remote and on-site monitoring visits audits inspections
• Creation of or completion of trial-related forms; maintaining trial master file documentation
• Communicating with patients multidisciplinary hospital team members external hospitals and other health services to obtain medical information for study participants
• Communication with external partners such as sponsors and CROs
• Preparing processing and safe shipment of blood urine tissue specimens
• Supporting new trial activation activities such as sponsor communications departmental communication ethics submissions and administrative documentation
• Archiving trial records for completed studies
• May involve some patient-facing work such as administering questionnaires collecting medical information obtaining vital signs or consenting patients to research studies
• Maintain training and working knowledge of current regulations clinical trial-related guidance documents and institutional SOPs policies and working instructions
• Trial-related tasks and activities beyond what is listed on the posting as required by the trial team and as delegated by the Principal Investigator(s)
• May involve walking or pushing a cart of documents/supplies across Sunnybrook Bayview campus or lifting items less than 10kg

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 1-2 years of related professional or practical experience in clinical research preferred or the equivalent combination of education and professional experience
• 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 an asset
• Ability to understand 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 (EDC databases document portals etc)
• 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