Clinical Research Coordinator

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 Research & Innovation team. The Clinical Research Coordinator is an on-site role and will report to the Manager, Research Operations 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 the study related activities throughout the lifespan of research studies and clinical trials
- Coordinate and oversee the day-to-day research operations under the direction of the Manager, Research Operations and Principal Investigator (PI) including planning, implementing and coordinating all aspects of the study visit as per the study protocol and ICH/GCP guidelines.
- 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.
- Securely handle study data
- Collaborate with internal and external program stakeholders on the preparation of grant applications, reports, manuscripts, abstracts, posters, and presentations for internal and external promotion of research activities.

KEY REGULATORY AND COMPLIANCE RESPONSIBILITIES
- Health Canada Division 5 Compliance: Ensuring all clinical trials involving human subjects for drugs comply with Health Canada Food and Drug Regulations, Division 5.
- REB Submissions: Preparing, submitting, and maintaining documentation for Research Ethics Boards (REBs) and other regulatory bodies.
- Informed Consent Process: Ensuring the informed consent process is properly executed, documented, and that participants fully understand the research, risks, and their rights.
- Adverse Event Reporting: Documenting and reporting adverse events (AEs) and Serious Adverse Events (SAEs) to sponsors and REBs within required timelines.
- Study Documentation: Maintaining accurate and detailed source documentation (electronic files and hard copy documents), electronic regulatory binders, and case report forms (CRFs).
- Audit Readiness: Preparing for and assisting with monitoring visits, audits, and regulatory inspections.
- Investigational Product Management: Tracking study medication/device dispensing, accountability, and storage according to regulations

EDUCATION

• - Masters’s degree in a health or science-related field preferred. Applicants with Bachelor’s degrees may be considered.
  - Society of Clinical Research Associates (SOCRA) certification required.

QUALIFICATIONS

• - 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
  - Demonstrated skill in performing academic literature searches, completing grant applications, professional and academic writing, 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 for contributing 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.

EMPLOYMENT EQUITY & ACCESSIBILITY STATEMENT

Michael Garron Hospital (MGH) champions accessibility, diversity and equal opportunity through the creation of an inclusive and diverse work environment. At Michael Garron Hospital, we strive to be an equitable and inclusive employer. We encourage candidates from Black, First Nations, Métis and Inuit, racialized and LGBTQ2S+ communities, people of colour, women, people with disabilities and individuals who identify with the diverse communities that we serve, to join the MGH team.

Through our values of Compassion, Respect, Integrity, Inclusion and Courage, Michael Garron Hospital is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA) and Ontario Human Rights Code (OHRC). Should you require an accommodation at any stage of the recruitment process, please let us know how we can work with you to meet your needs.

This job posting is a confirmed, active vacancy for which we are currently seeking a qualified candidate.

MGH is committed to leveraging new technologies and working efficiently. As a result, artificial intelligence systems may be used as part of our process to screen, assess, and or select applicants for this position.