Job Description - CRA II - (Ontario/Regional/Oncology) (20003300)
CRA II - (Ontario/Regional/Oncology)-(20003300)
The Clinical Research Associate I (CRA I) will
perform monitoring and site management activities for Phase I-IV clinical
research projects to assess the progress of clinical projects at assigned
investigative/physician sites (either on site or remotely) and to ensure
clinical projects are conducted, recorded, and reported in accordance with the
protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP
and/or all applicable local and federal regulatory requirements. Requires
guidance and oversight, while developing an understanding of the drug
development and commercialization process.
qualification, site initiation, interim monitoring, site management activities and
close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP
and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.Uses judgment and experience to evaluate
overall performance of site and site staff and to provide recommendations
regarding site-specific actions; immediately communicates/escalates serious
issues to the project team and with guidance develops action plans.Maintains a working knowledge of ICH/GCP
Guidelines or other applicable guidance, relevant regulations, and company
·Verifies the process of
obtaining informed consent has been adequately performed and documented for
each subject/patient, as required/appropriate. Demonstrates diligence in
protecting the confidentiality of each subject/patient. Assesses factors that
might affect subject/patient’s safety and clinical data integrity at an
investigator/physician site such as protocol deviation/violations and
·For the Clinical
Monitoring/Site Management Plan (CMP/SMP):
oAssesses site processes
oConducts Source Document Review of appropriate site source documents and
oVerifies required clinical data entered in the case report form (CRF) is
accurate and complete
oApplies query resolution techniques remotely and on site, and provides
guidance to site staff as necessary, driving query resolution to closure within
oUtilizes available hardware and software to support the effective
conduct of the clinical project data review and capture
oVerifies site compliance with electronic data capture requirements
investigational product (IP) inventory, reconciliation and reviews storage and
security. Verifies the IP has been dispensed and administered to subjects/patients
according to the protocol. Verifies issues or risks associated with blinded or
randomized information related to IP. Applies knowledge of GCP/local
regulations and organizational procedures to ensure IP is appropriately
(re)labelled, imported and released/returned.
·Routinely reviews the
Investigator Site File (ISF) for accuracy, timeliness and completeness.
Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the
investigator/physician site is aware of the requirement of archiving essential
documents in accordance with local guidelines and regulations.
activities via confirmation letters, follow-up letters, trip reports,
communication logs, and other required project documents as per SOPs and Clinical
Monitoring Plan/Site Management Plan.Supports subject/patient recruitment, retention and awareness
strategies.Enters data into tracking
systems as required to track all observations, ongoing status and assigned action
items to resolution.
·For assigned activities,
understands project scope, budgets, and timelines; manages site-level
activities / communication to ensure project objectives, deliverables and
timelines are met.Must be able to
quickly adapt, with the oversight of the Lead CRA, to changing priorities to
achieve goals / targets.
·May act as primary
liaison with project site personnel, or in collaboration with another CRA or
Central Monitoring Associate (CMA).Ensures all assigned sites and project-specific site team members are
trained and compliant with applicable requirements.
·Prepares for and
attends Investigator Meetings and/or sponsor face to face meetings.Participates in global clinical monitoring/project
staff meetings (inclusive of Sponsor representation, as applicable) and attends
clinical training sessions according to the project specific requirements.
·Provides guidance at
the site and project level towards audit readiness standards and supports
preparation for audit and required follow-up actions.
QUALIFICATION REQUIREMENTS (please
indicate if ‘preferred’)
degree or RN in a related field or equivalent combination of education,
training and experience
of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
demonstrate good computer skills and be able to embrace new technologies
communication, presentation and interpersonal skills
to manage required travel of up to 50% on a regular basis
Tasks, duties, and responsibilities as listed in this job
description are not exhaustive. The Company, at its sole discretion and with no
prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and/or education will also be considered so
qualifications of incumbents may differ from those listed in the Job
Description. The Company, at its sole discretion, will determine what
constitutes as equivalent to the qualifications described above. Further,
nothing contained herein should be construed to create an employment contract.
Occasionally, required skills/experiences for jobs are expressed in brief
terms. Any language contained herein is intended to fully comply with all
obligations imposed by the legislation of each country in which it operates,
including the implementation of the EU Equality Directive, in relation to the
recruitment and employment of its employees.
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