Locations:
Toronto, Ontario Company:
Clin Surge Research
Reports to:
COO Position Summary Clin Surge Research is a network of independent clinical research sites focused on cardiometabolic and primary care clinical research.
The Clinical Research Site Manager (Toronto - Phase 1-3) will oversee the operational performance, quality, compliance, and staff development of Clin Surge Research locations in Toronto .
This role will provide day-to-day leadership and support to Clinical Research Professionals (CRPs), ensure adherence to applicable SOPs and GCP requirements, identify and mitigate operational and quality risks, and promote consistent, efficient research practices across both sites.
The successful candidate will serve as a key operational partner to site leadership and investigators, balancing quality oversight and process improvement with hands-on operational support when required.
Key Responsibilities 1.
CRP Leadership, Supervision & Development Support the recruitment, interviewing, selection, and onboarding of CRP staff.
Provide day-to-day supervision, coaching, and performance support to CRPs across both locations.
Establish clear expectations for CRP performance, productivity, quality, and compliance.
Coordinate and deliver ongoing training and professional development for CRPs based on individual needs, study requirements, audit findings, and organizational priorities.
Monitor staff performance and identify opportunities for coaching, process improvement, and skills development.
Promote consistency in research practices and operational standards across both sites.
Support the development of training materials, competency assessments, and role-specific resources.
Quality Management & Regulatory Compliance Maintain oversight of site compliance with company SOPs, applicable GCP requirements, study protocols, and other relevant regulatory expectations.
Review IMV follow-up letters and identify recurring findings, trends, and areas requiring corrective action.
Oversee the identification, documentation, follow-up, and closure of CAPAs related to major protocol deviations (MPDs) and other quality issues.
Conduct internal audits and quality reviews as required.
Identify systemic trends and proactively implement process improvements to prevent recurrence.
Prepare sites and staff for sponsor/CRO audits, regulatory inspections, and other external quality assessments.
Lead or coordinate site responses to audit and inspection findings, including development and monitoring of corrective and preventive actions.
Continually review and improve company SOPs, workflows, forms, source templates, and other quality documentation.
Support the creation, review, and quality-checking of source documents and study-specific materials as required.
Promote a culture of quality, accountability, inspection readiness, and continuous improvement.
Research Operations Oversight Oversee CTMS visit tracking, scheduling, and operational workflows across the Hamilton and Mississauga sites.
Regularly review CTMS reports and operational metrics to identify trends, bottlenecks, workload concerns, and opportunities for improvement.
Use CTMS data to support CRP workload and performance evaluation.
Maintain oversight of the electronic Investigator Site File (eISF) and coordinate document review and cleanup activities as needed.
Monitor overall study and site operational health and escalate emerging concerns to leadership.
Identify operational, compliance, staffing, and quality risks and coordinate appropriate mitigation plans with site leadership.
Support study builds, configuration, and maintenance within the CTMS when required.
Promote consistent processes and workflows across both locations.
Assist with prioritization and resource…
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