Locations: Hamilton & Mississauga, Ontario
Company: ClinSurge Research
Reports to: COO
ClinSurge Research is a network of independent clinical research sites focused on cardiometabolic and primary care clinical research.
The Regional Clinical Research Site Manager (Hamilton & Mississauga) will oversee the operational performance, quality, compliance, and staff development of ClinSurge Research locations in Hamilton and Mississauga. 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.
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Support the recruitment, interviewing, selection, and onboarding of CRP staff.
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Provide day-to-day supervision, coaching, and performance support to CRPs across both locations.
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Establish clear expectations for CRP performance, productivity, quality, and compliance.
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Coordinate and deliver ongoing training and professional development for CRPs based on individual needs, study requirements, audit findings, and organizational priorities.
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Monitor staff performance and identify opportunities for coaching, process improvement, and skills development.
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Promote consistency in research practices and operational standards across both sites.
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Support the development of training materials, competency assessments, and role-specific resources.
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Maintain oversight of site compliance with company SOPs, applicable GCP requirements, study protocols, and other relevant regulatory expectations.
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Review IMV follow-up letters and identify recurring findings, trends, and areas requiring corrective action.
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Oversee the identification, documentation, follow-up, and closure of CAPAs related to major protocol deviations (MPDs) and other quality issues.
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Conduct internal audits and quality reviews as required.
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Identify systemic trends and proactively implement process improvements to prevent recurrence.
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Prepare sites and staff for sponsor/CRO audits, regulatory inspections, and other external quality assessments.
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Lead or coordinate site responses to audit and inspection findings, including development and monitoring of corrective and preventive actions.
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Continually review and improve company SOPs, workflows, forms, source templates, and other quality documentation.
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Support the creation, review, and quality-checking of source documents and study-specific materials as required.
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Promote a culture of quality, accountability, inspection readiness, and continuous improvement.
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Oversee CTMS visit tracking, scheduling, and operational workflows across the Hamilton and Mississauga sites.
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Regularly review CTMS reports and operational metrics to identify trends, bottlenecks, workload concerns, and opportunities for improvement.
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Use CTMS data to support CRP workload and performance evaluation.
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Maintain oversight of the electronic Investigator Site File (eISF) and coordinate document review and cleanup activities as needed.
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Monitor overall study and site operational health and escalate emerging concerns to leadership.
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Identify operational, compliance, staffing, and quality risks and coordinate appropriate mitigation plans with site leadership.
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Support study builds, configuration, and maintenance within the CTMS when required.
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Promote consistent processes and workflows across both locations.
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Assist with prioritization and resource allocation when competing study or site demands arise.
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Maintain regular communication with Principal Investigators (PIs) and Sub-Investigators (SIs) across both sites.
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Develop strong working relationships with investigators and incorporate their feedback into site processes and workflows.
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Identify and address operational barriers that may affect investigator engagement, study execution, or research referrals.
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Support the development and implementation of processes that facilitate efficient and frictionless research referrals.
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Support the identification and engagement of potential new research investigators.
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Assist with onboarding new investigators and provide foundational training regarding research processes, GCP, SOPs, and site expectations.
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Provide hands-on operational support as a backup CRC when required to maintain study continuity and site performance.
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Provide backup laboratory support, within applicable training and competency requirements.
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Assist with critical study activities during periods of increased workload, staffing shortages, or other operational needs.
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Maintain sufficient familiarity with site workflows to provide effective coverage when required.
The individual in this role will be expected to proactively identify opportunities to improve how ClinSurge Research operates. This includes:
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Identifying recurring operational or quality issues and addressing root causes rather than only individual findings.
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Establishing and monitoring action plans for identified risks.
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Using CTMS, audit, monitoring, and operational data to inform decisions.
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Standardizing processes between Hamilton and Mississauga where appropriate.
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Escalating significant risks, compliance concerns, staffing issues, and performance concerns to leadership in a timely manner.
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Supporting a culture in which quality and operational efficiency are viewed as shared responsibilities.
Leadership & People Management
Ability to coach, develop, motivate, and hold CRPs accountable to operational and quality standards.
Quality & Compliance
Strong commitment to GCP, SOP adherence, inspection readiness, and continuous quality improvement.
Operational Excellence
Ability to identify inefficiencies, establish effective workflows, and ensure consistent execution across multiple sites.
Problem Solving & Risk Management
Ability to recognize emerging risks, determine root causes, and implement practical corrective and preventive actions.
Communication & Collaboration
Ability to build effective relationships with investigators, research staff, sponsors, CROs, and leadership.
Adaptability
Comfortable balancing managerial responsibilities with hands-on clinical research support based on site needs.
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