Research Coordinator I Clinical Research Program

Research Coordinator I

The Research Institute is currently looking for a dynamic team player with excellent skills and experience in regulated clinical trials to fill an exciting new position as a Research Coordinator I.

Working within a newly established central clinical research unit, the position supports the efficient start-up, execution, and close-out of industry-sponsored clinical trials in compliance with Good Clinical Practice, Health Canada regulations, Division 5 of the Food and Drug Regulations, and institutional policies. The position will initiate new and support ongoing studies, including screening and recruiting eligible patients, obtaining informed consent, performing protocol-defined procedures, and accurately record study data in accordance with regulatory and quality standards.

The successful candidate will coordinate study activities across multiple investigators and clinical teams, standardizing workflows, supporting ethics and regulatory submissions, and ensuring accurate data collection and reporting. The position collaborates closely with sponsors and internal stakeholders to facilitate timelines, recruitment, and protocol adherence, while contributing to the development of streamlined processes and quality oversight within a growing centralized research infrastructure.

Additionally, the candidate will be responsible for providing administrative support including tracking and administering study related payments, maintaining appropriate inventory for study supplies, maintaining current lab licenses, freezer/drug logs and training certificates.

This position is full-time onsite with the option for occasional remote work.

Don’t meet every single requirement? Studies have shown that people in underrepresented communities are less likely to apply to jobs when they don’t meet every single qualification. We are dedicated to building an inclusive workplace, so if you’re excited about this role but your past experience doesn’t align perfectly, we still welcome you to apply.

Duties & Responsibilities:

Administrative Duties (50% of work time)

• Creates trainings, manuals, e-learning content as needed.
• Organizes, facilitates, and runs meetings with internal teams, and external stakeholders.
• Facilitates the communication plan for internal and external stakeholders. Disseminates information as needed.
• Ensures maintenance, collection, transcription, and entry of study related data, in accordance with hospital and privacy regulations.
• General office duties e.g., filing, mailings, courier services, ensuring stocked and maintained inventory /supplies/equipment/software.
• Designs all source documents (templates, tracking files, forms, guidance documents) for the collection, and management of information/data.
• Organizes, sets up, and maintains equipment used in clinical research studies.
• Provides high quality customer service experience when working with sponsors and external parties.

Research Specific Tasks (40% of work time)

• Assists Principal Investigators and Research Program Manager in the initiation of new industry sponsored clinical trials and:
• Coordinates and conducts screening, recruitment, and follow-up visits with participants.
• Manages, prepares, and oversees monitors/audits.
• Monitors, and controls research regulations, quality, and guidelines, including ethical (e.g., REB submissions), and safety protocols.
• Writes and administers informed consent forms.
• Arranges timely payments to participants.
• Plans, organizes, directs, controls, and evaluates the activities and operations of research trials.
• Liaises with multiple internal and external stakeholders at local and international levels, navigates stakeholder relationships, and responds proactively to anticipated challenges.
• Helps develop processes, tools (workflow, Gantt charts), and resources to support team members, and projects.
• Troubleshoots/solves logistical and technical obstacles.
• Biological sample collection (Phlebotomy, dry blood spot testing etc.), processing and shipping according to Transportation of Dangerous Goods (TDG) and International Air Transport Association (IATA)
• Maintains awareness of health and research news, events, and current high-profile research activities.

Day to day project and staff guidance tasks (10% of work time)

• May train, coordinate, and/or delegate tasks (including overseeing quality control of submitted assignments) to Research Assistants, casual staff, students and internal/external collaborators.
• May develop and implement policies, standards and procedures for the clinical trials and research operations in the department.

Performs cross functional and other duties as assigned and/or requested.

• All staff are expected to carry out their assigned duties and responsibilities in a manner which prioritizes patient and employee safety, and confidentiality. Key accountabilities in this regard include:
• Strict compliance with patient/employee confidentiality practices and policies.
• Strict compliance with patient/employee safety practices and standards.
• Appropriate identification, reporting and response to patient/employee confidentiality breaches in accordance with established policies and procedures.
• Appropriate identification, reporting and response to patient/employee safety risks and incidents/events in accordance with established policies and procedures.

Qualifications:

• Undergraduate Degree (Health Sciences preferred) and 2 years of relevant experience, OR demonstrable equivalent combination of specialized education and experience.
• Experience with regulated clinical drug trials is preferred.
• TCPS CORE 2, Good Clinical Practice and Health Canada Div 5 certificates are an asset. (Completed within first 2 weeks of hire)
• Experienced phlebotomist with workshop certificate is an asset.
• Completed a Clinical Research Academic Certificate Program is preferred
• Clinical research professional designation is an asset (e.g., SOCRA, ACRP etc.).
• Basic understanding of science, including applicable theories, frameworks, and models.
• Excellent project coordination and problem solving skills.
• Experience working with a diversity of stakeholders is an asset.
• Empathy and ability to cope with emotionally difficult situations participants may be facing.
• Basic computer skills with Microsoft Office experience, and database software (electronic data capture such as REDCap or Medidata).
• Ability to work independently and as part of a team
• Organization skills and ability to manage multiple projects simultaneously.
• Excellent communication skills and strong interpersonal agility is an asset

Unity Health Toronto is committed to creating an accessible and inclusive organization. We strive to provide a recruitment process that is barrier-free and in compliance with the Accessibility for Ontarians with Disabilities Act (AODA) and the Ontario Human Rights Code. We understand that you may require an accommodation at any stage of the recruitment process. When you are contacted, please inform the Talent Acquisition Specialist and we will work with you to meet your accommodation needs. We want to emphasize that all accommodation requests are handled with the utmost confidentiality, respecting your privacy and dignity.

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