Clinical Research Coordinator

3 months ago

Toronto, Canada Michael Garron Hospital Full time

Position Overview

For the East Toronto neighbourhoods we serve, Researchers at Michael Garron Hospital (MGH) are driven by an unrelenting imperative to make healthcare work better. Our research is rooted where our care is provided. We focus on the immediate and the pragmatic: health quality improvements that our team knows will make a difference.

We are seeking a full-time Clinical Research Coordinator to support the Thoracic Surgery research team. MGH is a level one Thoracic Surgery Centre that encompasses nearly all areas of chest surgical disease, benign and malignant. The Clinical Research Coordinator will report to the Division Head/Principal Investigator, and Manager of Research and Innovation and will coordinate and oversee efforts across the research continuum including protocol development, research ethics board submissions, project budgets, participant enrollment, data collection and management, and project close-out.

Primary Responsibilities

Coordinate and oversee the day to day research operations under the direction of the Principal Investigator (PI) including planning, implementing and coordinating all aspects of the study visit as per the study protocol and ICH/GCP guidelines.

Establish and maintain regulatory compliance of research activities. This includes the routine completion of education and training for research ethics compliance, the development and maintenance of study research ethics board submissions, the maintenance of study manuals of procedures, and other duties identified by the PI to support regulatory compliance.

Develop/implement and maintain data collection instruments, surveys, and project databases in support of the division’s active research protocols.

Participate in all aspects of study participant recruitment including identifying/screening research participants and performing and documenting informed consent procedures.

Report any study related abnormalities as per defined parameters (e.g., approved protocol or documented investigator instructions) to the PI.

Support the PI and department of Research and Innovation in management and monitoring of the program’s budget expenditures, including processing reimbursements/stipends as applicable, and preparing materials for monthly and quarterly invoicing.

Perform safe specimen handling and transport including sample collection, processing and shipment.

Prepare for study monitor visits, liaise with study monitors and work to resolve outstanding issues/problems in a timely manner

Securely handle study data

Decision Making

Required to work with a high degree of autonomy and possess strong analytical, interpersonal and problem solving abilities to strategize and implement projects and programs.

Decisions require keen judgment, careful consideration and intimate knowledge of hospital operations and organizational structure

There is extensive collaboration with external research collaborators and research coordinators.

Education

Bachelor’s degree in a health or science-related field

Certification as a Clinical Research Professional is an asset

Experience

Minimum 3 years’ experience in clinical research required.

Knowledge of research regulations and guidelines including TCPS 2, ICH/GCP, Declaration of Helsinki, Health Canada Division 5, FDA Code of Federal Regulations, required.

Knowledge and experience in obtaining informed consent for research studies.

Knowledge and experience in administering survey instruments.

Experience with computer data management and analysis software including REDCap, SPSS, preferred.

Knowledge of International Air Transportation Authority (IATA) shipping regulations relating to Transportation of Dangerous Goods (TDG) preferred

Venipuncture certification or a willingness to learn, preferred

Exceptional organizational skills and attention to detail.

Able to work independently, without immediate supervision, and as part of a team.

A high degree of professionalism and respect for colleagues.

Demonstrated ability to manage conflicting priorities and confidential data.

All employees of Michael Garron Hospital (MGH), a division of Toronto East Health Network (TEHN) [formerly Toronto East General Hospital (TEGH)] agree to work within the legislated practices of the Occupational Health and Safety Act of Ontario.

All employees of MGH are responsible to contribute to a transparent culture of patient and staff safety by adhering to and abiding by patient and staff safety policies and procedures set by MGH.

All employees are accountable for protecting the psychological health and safety of themselves and their co-workers through adherence to MGH's policies and practices.

Vaccines (COVID-19 and others) are a requirement of the job unless you have an exemption pursuant to the Ontario Human Rights Code.

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