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Clinical Research Associate

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Competition Number: J0522-1144
Position Title: Clinical Research Associate
Employee Group: Research, Grant & Contract
Job Category: Research
Department or Area: Canadian Cancer Trials Group
Location: Kingston, Ontario, Canada
Salary: $55,670.00/Year
Grade: 07
Hours per Week: 35
Job Type: Permanent (Continuing)
Shift: 7 Monday - Friday
Number Of Positions: 1
Date Posted: September 20, 2022
Closing Date: October 5, 2022

COVID 19 On-Campus Requirements

The Queen’s University Policy Regarding Mandatory Vaccination Requirements for In-person University Activities requires ALL Community Members, including employees, to be Fully Vaccinated against COVID-19 prior to participating in any In-person University Activities. This is a condition of employment for all employees who are required to attend University Property to perform their employment responsibilities. Individuals who cannot be vaccinated due to substantiated grounds (medical and other protected grounds under the Ontario Human Rights Code) may ask the University to validate the exemption and request an accommodation for these rare circumstances. If approved, they will be subject to additional health and safety measures.

About Queen's University

Queen’s University is the Canadian research intensive university with a transformative student learning experience. Here the employment experience is as diverse as it is interesting. We have opportunities in multiple areas of globally recognized research, faculty administration, engineering & construction, athletics & recreation, power generation, corporate shared services, and many more.

We are committed to employment equity and diversity in the workplace and welcome applications from individuals from equity seeking groups such as women, racialized/visible minorities, Indigenous/Aboriginal peoples, persons with a disability, persons who identify in the LGBTQ+ community and others who reflect the diversity of Canadian society.

Come work with us!

Job Summary

Reporting to the Manager, Office of Clinical Trials Management, the Clinical Research Associate will work within a team-based structure to support the conduct of national, international and cooperative oncology group, multi-centre, multi-modality clinical trials in cancer therapy, prevention and supportive care. Responsibilities include: critical evaluation of incoming information, including medical data, for accuracy, relevance and prioritization, assisting in the development of clinical trials protocols, case report forms and other trial related materials, communicating with participating centre staff (cancer treatment centres) to promote and understanding of the trial, and accurate data collection in accordance with ICH-GCP and other relevant guidelines.

Job Description

KEY RESPONSIBILITIES:
• In an evolving electronic environment, perform independent review of selected case report forms and reconcile against medical supporting documentation for patients entered on assigned trials. Stipulate and enforce documentation requirements, clarify ambiguities, query to ensure accurate reporting, and request missing or late data. Ensure compliance with relevant regulations.
• Participate in system-based, SAS and manual edit checking of data, including design of data-checking programs, implementation of checks, review of output and query/resolution of errors, to ensure accuracy of the clinical database.
• Communicate with cancer centre staff, as necessary, to promote an understanding of the protocol requirements, data capture, and adherence to relevant policies. Participate in finding solutions to problems in clinical trials conduct. May prepare charts for site monitoring visits/resolve findings. May assist in preparation of draft reports and materials for scientific meetings.
• Apply an understanding of clinical trial design, methodology and data collection to assist in study preparation processes including contributions to the study protocol, intergroup appendix, case report forms and educational materials (newsletters, guidebooks). Participate in trial activation, analysis meetings and other processes relating to ongoing study conduct.
• Contribute to the understanding and improvement of trial management processes by active participation on internal committees and in trial team meetings and processes.
• Undertake additional responsibilities as assigned in support of the unit.

REQUIRED QUALIFICATIONS:
• Bachelor's degree in health science preferred.
• Previous experience (minimum 1-2 years) in a clinical research setting.
• Consideration may be given to an equivalent combination of education and experience.

SPECIAL SKILLS:
• Respects diversity and promotes inclusion in the workplace.
• Well-organized with excellent attention to detail.
• Well-developed data evaluation skills within a medical context.
• Ability to work under pressure and to deadlines.
• Understanding of IT systems capabilities including evolving electronic data capture systems.
• Computer skills including Microsoft Word, Excel, Oracle, electronic data capture.
• Good judgment and problem-solving ability.
• Excellent verbal and written communication skills to interact with a diverse group of individuals, in a professional and concise manner.
• Consultative, collaborative, ability to work within a team.
• Multi-tasking abilities, ability to understand competing priorities.
• Flexible, willingness to learn, receptive to evolution in clinical trials environment.

DECISION MAKING:
• Respond to inquiries from cancer treatment centres regarding interpretation of protocols and forms, patient eligibility and patient management, understanding when additional information is required and when to involve other trial team members.
• Ongoing assessment of workload priorities to integrate the overall organization, day-to-day administration, medical review of data and analyses of assigned trials.

Employment Equity and Accessibility Statement

The University invites applications from all qualified individuals. Queen’s is committed to employment equity and diversity in the workplace and welcomes applications from women, visible minorities, Aboriginal Peoples, persons with disabilities, and persons of any sexual orientation or gender identity. In accordance with Canadian Immigration requirements, priority will be given to Canadian citizens and permanent residents.

The University provides support in its recruitment processes to applicants with disabilities, including accommodation that takes into account an applicant's accessibility needs. Candidates requiring accommodation during the recruitment process are asked to contact Human Resources at hradmin@queensu.ca.

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