Cancer Research Study Coordinator

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Job Summary

The Canadian Cancer Trials Group (CCTG) at Queen’s University is seeking an individual who holds a graduate degree in the health sciences field to join our group as a Cancer Research Study Coordinator. Candidates must have some exposure to scientific research, which may have been obtained as part of their graduate degree, and/or through post-graduate employment. Ideal candidates will bring an enthusiasm to the CCTG team as they contribute to the development, data collection and analysis of Canadian and international clinical trials in cancer therapy, prevention and supportive care that inform cancer treatment.

This is a great opportunity for a recent graduate who is interested in work that has the potential to inform current medical practices and improve health outcomes for cancer patients. While working as a Cancer Research Study Coordinator you will have the opportunity to collaborate with participating centres (cancer treatment centres), trial committees (including investigators, clinical research associates and pharmacists), industry partners and others across Canada and around the world. The CCTG team is dedicated and passionate about the important work they do and balance their hard work by ensuring the environment is collaborative, inclusive and one that promotes effective relationships among team members.

If you hold a graduate degree in a health-related discipline and are looking for a rewarding career opportunity that will have a positive social impact, we encourage you to apply.

Job Description

KEY RESPONSIBILITIES:
• Apply an understanding of clinical trials methodology, data collection and analysis, and cancer biology, diagnosis and treatment in order to contribute to the design and development of multi-centre clinical trials in cancer therapy and supportive care. Research and write specific sections of protocols and trial specific grant applications. Develop familiarity with correlative study endpoints (including tumour banking, patient reported outcomes, and economic analysis) and logistics to ensure successful completion of these aspects of clinical trials. Develop written materials for general education, trial specific training for participating sites, and contribute to abstracts, presentations and eventual publication of study results.
• Apply an understanding of current computer systems and applications in clinical trials conduct to coordinate the establishment, testing and maintenance of a coherent and consistent database for each assigned trial. Create and/or utilize templates to develop trial specific paper or electronic case report forms, including system-based, SAS and manual edit checks that will ensure accuracy of the clinical database. Coordinate the process of computerized data retrieval by interacting with the computing and biostatistics teams. Contribute to the development of the statistical analysis plan where appropriate, preparation of annual reports.
• Assess and interpret data and reconcile against medical supporting documentation on participants entered on assigned trials with particular emphasis on ensuring protocol compliance, monitoring toxicity and verifying patient response to treatment. Using established metrics/reports, monitor all assigned trials for unexpected trends in patient accrual, eligibility, toxicity, response, deaths and patterns of practice which may compromise trial integrity. Query to ensure accurate reporting of complex endpoints, including response assessment, treatment modifications and adverse events. Stipulate and enforce documentation requirements, clarifying ambiguities and requesting missing or late data. Ensure compliance with relevant regulations including timely reporting of all serious adverse events and coordination/management/documentation of the investigational medicinal product supply.
• Provide guidance and support for study conduct to participating member centres, external committees (including investigators, clinical research associates, and pharmacists), industry partners and others, as required. Utilize current technologies to actively promote trials to participating sites; conduct site training, including development and presentation of training materials. Act as a resource for site questions about study design, conduct and data capture. Interact with internal departments (information technology, audit and monitoring, ethics and regulatory, finance) to ensure timely and efficient trial conduct; participate on internal committees to advance/improve internal processes. Roles may also include membership on disease site committees and opportunities for contribution to the international clinical trial enterprise.
• Study Coordinators delegate work and ensure its completeness and accuracy to team members including research associates, clinical trials assistants, and students. Participates in the training and mentoring of new study coordinators and others.

REQUIRED QUALIFICATIONS:
• Graduate degree in a relevant discipline.
• Two years experience in one or more of the following: clinical research, clinical trial methodology, oncology, or health sciences. This experience can come during completion of a graduate degree.
• Consideration will be given to an equivalent combination of education and experience.

SPECIAL SKILLS:
• Understanding of IT systems capabilities including evolving electronic data capture systems (e.g. Medidata Rave).
• Computer skills including WORD, Excel, Oracle, electronic data capture (e.g. RAVE).
• Knowledge of statistics, data checking and SAS.
• Excellent organizational skills.
• Strong task oriented work ethic; work to tight deadlines.
• Flexible with respect to ongoing evolution of work practices.
• Attention to detail.
• Superior communication skills both written and verbal.
• Ability to work both independently and as a team member to liaise effectively in a professional and cooperative spirit with colleagues within the central office and at national and international study sites.
• Proactive, consultative, collaborative.
• Proven problem solving and analytical skills, and the ability to conceptualize, assimilate and evaluate information from multiple sources.
• Manage stakeholder expectations.
• Ability/enthusiasm to learn new skills.
• Ability to prioritize competing demands.
• Ability to critically and accurately review and interpret medical data.
• Project management to monitor progress and ensure deliverables.
• Working knowledge of French is an asset.

DECISION MAKING:
• Make independent decisions in response to issues arising in trial development and ongoing management of active trials. These may include queries from cancer treatment centres and industry partners regarding interpretation of protocols, forms, patient eligibility and patient management.
• Determine when, how and to whom to report serious adverse events.
• Independent, ongoing assessment of workload priorities is essential to integrate the overall organization, day-to-day administration, medical review of data and analyses of many trials.

Employment Equity and Accessibility Statement

The University invites applications from all qualified individuals. Queen's 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+ persons. In 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.