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 Lung 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:
Maintaining documentation as part of the trial master file creating source documents
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 ethics review process and supporting in submissions and documentation updates
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 of trial metrics and other research-related activities within the needs of the team
Supporting the activation activities of new clinical trials 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 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
Interested candidates please apply online and complete all screening questions in the online portal.
We thank all applicants for their interest. However only candidates selected for an interview will be contacted. Sunnybrook Health Sciences Centre is an equal opportunity employer.
Required Experience:
IC
Summary of Duties and Responsibilities: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 Manag...
Summary of Duties and Responsibilities:
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 Lung 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:
Maintaining documentation as part of the trial master file creating source documents
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 ethics review process and supporting in submissions and documentation updates
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 of trial metrics and other research-related activities within the needs of the team
Supporting the activation activities of new clinical trials 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 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
Interested candidates please apply online and complete all screening questions in the online portal.
We thank all applicants for their interest. However only candidates selected for an interview will be contacted. Sunnybrook Health Sciences Centre is an equal opportunity employer.
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