Cancer Research Study Coordinator

Queen's University; Eastern Ontario; On-site; CAD 65,000 - 85,000; Full time

Job summary

A leading educational institution is seeking a Study Coordinator to oversee and coordinate multi-centre clinical trials in cancer therapy and supportive care. The role involves developing trial protocols, maintaining databases, and ensuring compliance with regulations. Ideal candidates should have a strong understanding of clinical trials methodology and excellent data management skills, contributing to critical research in the oncology field.

Qualifications

• Understanding of clinical trials methodology and cancer treatment.
• Experience in coordinating clinical trial processes and compliance.
• Skilled in data management and analysis.

Responsibilities

• Coordinate and oversee multi-centre clinical trials in cancer research.
• Develop trial protocols and oversee database maintenance.
• Monitor trial integrity and data accuracy.

Skills

Clinical trials methodology

Data collection and analysis

Cancer biology

Computer systems in clinical trials

Protocol compliance

Job description

Job Summary

The Study Coordinator works within a team based structure to coordinate and oversee national, international and cooperative oncology group, multi-centre, multi-modality clinical trials in cancer therapy, prevention and supportive care. Design, develop clinical trials protocols and data collection modules. Establish and maintain a coherent database. Work collaboratively with participating centres (cancer treatment centres) and trial committees (including investigators, clinical research associates, pharmacists), industry partners and others in an evolving international clinical trials environment. Promote an awareness and understanding of trial design, goals, and procedures in compliance with ICH- GCP and other relevant guidelines. Critical evaluation of incoming information, including medical data, for accuracy, relevance and prioritization. Orchestrate trial analyses leading to the dissemination of results and eventual publications.

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.