Clinical Research Associate - Oncology Academy

COVID 19 On-Campus Requirements

Prior to May 1 2022 the University required all students faculty staff and visitors (including contractors) to declare their COVID-19 vaccination status and provide proof that they were fully vaccinated or had an approved accommodation to engage in in-person University activities. These requirements were suspended effective May 1 2022 but the University may reinstate them at any point.

Queens University is the Canadian research intensive university with a transformative student learning experience. 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.

At Queens we are committed to helping people achieve their best. Disclaimer: As part of the application process at Queens University our recruitment system uses Artificial Intelligence (AI) as defined under the Ontario Employment Standards Act to ask job-related questions and confirm eligibility for hire. Reporting to the Team Lead the Clinical Trial Assistant (CTA) is responsible for administration within a trial team and provides support for communication and meetings trial coordination and conduct data management and quality as well as other key activities. Working within a collaborative team-based structure the CTA supports the conduct of national international cooperative oncology group multi-centre clinical trials in cancer therapy prevention and supportive care. Understands general clinical trials research principles regulations and guidelines and adheres to Group Standard Operating Procedures (SOPs) and Work Instructions (WKIs). CTAs facilitate network engagement through support of participating centres as well as network members and external partners.

The Clinical Trial Assistant (CTA) is the key individual responsible for administration in a trial team environment. Maintains trial websites including coordination of collection and dissemination of confidential trial information.

As the first point of contact from participating centres and other external partners builds and maintains relationships with key network stakeholders. Proactively participates in timely management of key trial milestones including site activation or data locks. Provides meeting support to trial teams and disease site committees using in-person and online formats and tools as required. Assists with preparation of agendas correspondence and drafts minutes. g Creates other materials for meetings if requested.

In partnership with the Study Coordinator monitors the trial (central and local) activation process to ensure key administrative steps have been completed and milestones are met. Identifies any risks or challenges to ensure they are resolved promptly to facilitate the activation process.

Data Management and Data Quality

Holds expertise in the use of computer systems and applications in clinical trials conduct (Mango OPEN Oracle and EDC Medidata Rave and REDcap). Accurately processes patient registration/randomization and incoming data in a time-sensitive manner.

Creates guidance documents for logistics of patient partnership with the Study Coordinator during database development supports formatting of mock case report forms for posting and distribution.

Supports oversight of data and query progress including form submission and query resolution processes to ensure quality. During data review and analysis supports investigation and resolution of data submission and query resolution issues noted. Additionally assists with complex logistics of platform trials (e.g. master protocol and patient matching steps) and supports CCTG-wide database maintenance and/or trial conduct activities (e.g. Electronic Data Capture Lab Database data tracking to ensure provision of funding to Participating Centres)

Completes quality assurance checks identifies gaps and reviews issues identified with the Study Coordinator/trial team. Follows up to ensure resolution of outstanding and/or inaccurate TMF content. Completes final quality assurance check prior to TMF transfer to external partners.

Completes quality assurance checks triages all documents received and identifies those that require further follow up for national and international clinical trials.

Correlative Science Activities

Supports clinical trial requirements for correlative science including liaising on behalf of the trial team with the Tumor Tissue Data Repository to ensure the required correlative kits are distributed to participating centres/groups. Conducts reconciliation on samples collected throughout the trial to ensure all is received for analysis.

Post-Secondary education in office administration in a medical / health related area or other relevant discipline.

Minimum 3-5 years of administrative experience in a research / medical setting.

Knowledge of clinical trials oncology and medical and scientific terminology would be considered assets.

Excellent time management and highly effective organizational/administrative skills to deal with volume of work and conflicting priorities ensuring deadlines are met and trial documentation is appropriately organized and filed. Sound knowledge of office procedures including filing systems.

Strong customer focus: ability to meet the needs of internal and external contacts professionally and effectively with a proven ability to establish and maintain effective working relationships with others.

Excellent writing skills to draft correspondence. Highly proficient in the use of word processing PowerPoint spreadsheets web authoring and database software as well as in-house applications. Ability to adapt readily to the implementation of new technologies.

Identify and bring forward issues that arise through meetings or daily interactions that need resolution or clarification by more senior staff.

Handle and refer incoming correspondence and phone calls to the appropriate individual for follow-up particularly those which are time or content sensitive.

Cancer Trial Support Unit) on administrative tasks (e.g. participant enrollments) understanding when additional information is required and when to involve other trial team members.

Determine when questions would be more appropriately answered by the Study Coordinator or Senior Investigator. Employment Equity and Accessibility Statement

Queens is strongly committed to employment equity diversity and inclusion in the workplace and encourages applications from Black racialized persons Indigenous people women persons with disabilities and 2SLGBTQI accordance with Canadian Immigration requirements priority will be given to those who are legally eligible to work in Canada.

The University provides support in its recruitment processes to all applicants who require accommodation due to a protected ground under the Ontario Human Rights Code including those with disabilities.