Research Coordinator I, Clinical Research Program

Role Overview

This opportunity is for a Research Coordinator I to join a newly created central clinical research unit at St. Michael's Hospital. The role focuses on supporting industry-sponsored clinical trials from start-up through execution and close-out, with work carried out in line with Good Clinical Practice, Health Canada requirements, Division 5 of the Food and Drug Regulations, and internal institutional policies.

The coordinator will help launch new studies and keep active trials moving efficiently by screening and enrolling eligible participants, obtaining informed consent, carrying out protocol-driven procedures, and capturing study information accurately and on time. The role also involves working across investigators, clinical teams, sponsors, and internal partners to support study timelines, recruitment, ethics and regulatory submissions, and protocol compliance.

In addition to research coordination, the position includes administrative support such as managing study-related payments, keeping supplies and equipment stocked, and maintaining current lab licenses, freezer and drug logs, and training records. This is a full-time onsite role with the possibility of occasional remote work.

Administrative Duties

About half of the role is focused on administrative and operational work. This includes building training materials, manuals, and e-learning content when needed; arranging and leading meetings with internal and external stakeholders; supporting communication plans and information sharing; and ensuring study data is collected, transcribed, entered, and stored in accordance with hospital privacy rules.

Other duties include general office administration such as filing, mail handling, courier coordination, and maintaining adequate supplies, equipment, and software. The role also involves creating source documents such as templates, tracking tools, forms, and guidance materials, as well as setting up and maintaining clinical research equipment.

The coordinator is expected to provide a strong customer service experience to sponsors and outside partners.

Research-Specific Duties

Roughly 40% of the work centers on clinical research tasks. The coordinator will assist Principal Investigators and the Research Program Manager with launching new sponsored trials, coordinating participant screening, recruitment, and follow-up, and helping manage study monitors and audits.

The role also includes overseeing research quality, safety, and regulatory requirements, including ethics board submissions and safety-related procedures. Responsibilities extend to drafting and managing informed consent forms, arranging participant payments, planning and evaluating trial operations, and maintaining communication with local and international stakeholders.

The successful candidate will also contribute to process improvement by developing workflows, Gantt charts, and other resources, while resolving operational or technical issues. Biological sample handling may also be required, including phlebotomy, dry blood spot testing, processing, and shipping in compliance with TDG and IATA standards.

Staying informed about health and research developments, events, and notable research activity is also part of the role.

Team Guidance and Cross-Functional Support

About 10% of the position may involve mentoring, coordinating, or assigning work to Research Assistants, casual staff, students, and other collaborators, along with checking the quality of submitted work. The coordinator may also help build and roll out policies, standards, and procedures for clinical trials and research operations.

Safety, Confidentiality, and Organizational Expectations

All staff are expected to complete their assigned work with a strong focus on patient and employee safety as well as confidentiality. This includes strict adherence to confidentiality practices, following safety standards, and promptly reporting any breaches, risks, incidents, or events according to established procedures.

Qualifications

The preferred background is an undergraduate degree, ideally in Health Sciences, plus at least 2 years of relevant experience, or an equivalent combination of specialized education and experience. Experience in regulated clinical drug trials is preferred.

Helpful credentials include TCPS CORE 2, Good Clinical Practice, and Health Canada Division 5 certificates, which can be completed within the first 2 weeks after hire. An experienced phlebotomist with a workshop certificate is also an asset, as is completion of a Clinical Research Academic Certificate Program. A professional designation such as SOCRA or ACRP is considered an asset.

Candidates should have a working understanding of science and related frameworks, strong project coordination and problem-solving skills, and experience working with varied stakeholders. Empathy is important, along with the ability to handle emotionally difficult situations participants may be experiencing.

Solid computer skills are needed, including Microsoft Office and database or electronic data capture tools such as REDCap or Medidata. The role also calls for the ability to work both independently and as part of a team, manage multiple priorities at once, stay organized, and communicate clearly with strong interpersonal skills.

Inclusivity and Accommodation

The organization states that it is committed to an accessible and inclusive workplace and supports a recruitment process that is barrier-free and compliant with the Accessibility for Ontarians with Disabilities Act (AODA) and the Ontario Human Rights Code. Candidates who need accommodation at any stage of the hiring process are encouraged to let Talent Acquisition know, and requests will be handled confidentially with respect for privacy and dignity.

Additional Notes

Applicants are encouraged to apply even if they do not meet every listed qualification, as the employer values candidates from underrepresented communities and wants to support an inclusive hiring process.