||Dr. Amy Plint and Candice McGahern (ED Research Manager)
The Research Coordinator will play a vital role in the success of large clinical trials being led by the CHEO ED Research Group across Canada and other trials occurring within the Emergency Department of the Children’s Hospital of Eastern Ontario. The Research Coordinator will be responsible for coordinating and managing local, national and international clinical trials.
The Research Coordinator will require extensive knowledge in the management of Emergency Medicine Clinical Trials. The appropriate individual will have highly developed organizational, analytical, and problem-solving skills. This position requires technical proficiency with databases, data, statistics, and reporting. Must be able to manage effectively with complex issues and concerns and meet many stringent timelines.
Success in the role will require clear judgment and efficient and effective decision-making, creating and following procedures and guidelines set by the Principal Investigator, the CHEO ED Research Manager, and CHEO ED Research Team.
This position requires travel to multiple research study sites across Canada, as well to conferences, and investigator meetings.
- Leads, manages, or participates in projects as assigned
- Provides input into the day-to-day operational aspects of the project(s), including identifying and resolving issues and conflicts
- Supports the development and implementation of the planning and program development processes, including REB and Health Canada submissions
- Ensures support for the overall project vision
- Contributes to the formulation of policies, developing projects, and administering projects
- Responsible to plan work activities for independent action in controlling the quality of work performed
- Responsible for supporting and coordination of programs and projects
- In collaboration with the PI and ED Research Manager, develop the structure, objectives, and policies of the research project(s), evaluating research activities and recommending improvements when appropriate
- Monitor research funding and budgeting resources, collaborating with the PI and Research Accounting
- Responsible for overseeing the set up and execution of study legal contracts
- Develop project timelines, monitor and control of project deadlines, outcomes and closeout of projects
- Work closely with the PI in areas of analytics and reporting, in the development of documents and proposals for the purpose of presentation and publication
- Contribute to overall protocol development
- Develop and coordinate a variety of analytical processes using various systems required by the project(s)
- Develop, manage, and maintain complex databases for multiple projects.
- Manage project meetings, including investigator meetings (as scheduled) – may require travel
- Responsible for the coordination and administration of national and international clinical trials, as well as local programs and projects
- Coordination of the conduct of all study activities at multiple sites across the country
- May include being responsible for patient recruitment at a local level (including screening and obtaining consent)
- May include travel to study sites for monitoring and quality checks
- Analyzes issues, and defines project objectives, scope, implementation plans, resource requirements, and timelines
- Ongoing study status reports to all study team members (study sites, committees, etc.)
- Development of data collection tools, study procedure manuals, and relevant standard operating procedures
- Data collection, management, review, and cleaning
- Extraction of clinical data from medical records
- Understands and complies with all REB requirements and Health Canada requirements
- Oversee the work of multiple Research Assistants and Coordinators located at sites across the country
- Train site research coordinators/nurses/assistants on study policies and procedures
- Provide professional services to other team members, internal and external to the research, providing guidance and knowledge transfer in training, procedures, and policy development
· May be called upon by the Principal Investigator to act as their representative in the presentation of the research material to internal or external agencies, related publications, or journals
- Police Record Check (PRC) (Essential)
- University degree in a healthcare related field (Preferred)
- 3-5 years’ experience in an active clinical research program setting (Essential)
- 3 years or more of relevant planning and management experience (Preferred)
- 3 years or more of clinical trial specific experience (Essential)
- Able to speak, read, and write in both English and French (Preferred)
- Evidence of ongoing clinical research education and professional growth (Preferred)
- Knowledge of ICF/GCP Guidelines (Essential)
- Knowledge of Health Canada Regulations (Essential)
- TCPS2 Certification (Essential)
- Knowledge of research ethics and regulations for granting agencies (Essential)
- Leadership skills; demonstrate ability/comfort with decision making responsibilities (Essential)
- Proven ability to work independently, to set own priorities and deadlines (Essential)
- Ability to manage human, financial and physical resources within an operating environment (Essential)
- Advanced skills in statistical software and analysis programs (Preferred)
- Experience with professional writing, preparing reports, and conducting literature reviews (Essential)
- Advanced knowledge of REDCap database systems; ability to build and maintain a database (Preferred)
- Experience with protocol development; writing and contributing to the study protocol (Essential)
- Understanding of quality assurance procedures (Essential)
- Experience with Health Canada regulated clinical trials (Essential)
· Able to share information in an effective and collaborative manner
· Able to be creative, challenge and demonstrate initiative to generate improvements
· Able to work in a dynamic, often hectic environment and be able to multi-task
· Able to be flexible with working hours in order to meet deadlines
· Able to work under tight deadlines
· Able to work in a team as well as independently
Please forward all resumes and cover letters to Candice McGahern (email@example.com).
Should the applicant require any accommodations during the application process please notify CHEO RI Human Resources as per the Accessibility for Ontarians with Disabilities Act.
We thank all applicants for their interest. However, only those invited for an interview will be contacted.