Cancer Research Study Coordinator
2 months ago
Cancer Research Study Coordinator
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.
Come work with us
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.
**Job Description**:
**KEY RESPONSIBILITIES**:
- 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**:
- Master’s degree in Health Sciences or equivalent combination of education and experience in a medical, research or pharmaceutical setting.
- Minimum of 2-3 years relevant experience in one or more of the following: clinical research, clinical trial methodology, oncology, health sciences or 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 deli
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