Job Summary The Associate Director, Clinical Research Operations provides strategic leadership, operational oversight, and institutional accountability for the University's Clinical Research Operations portfolio. Reporting to the Director of Health Research Services, the Associate Director is responsible for developing, implementing, and continuously improving the University's clinical health research compliance framework to ensure adherence to federal and provincial legislation, Tri-Agency requirements, Health Canada regulations, institutional policies, and international standards governing human participant research.

Key Responsibilities

Strategic Leadership

- Develop and implement the University's strategic vision for Clinical Research Operations.
- Provide expert advice to senior University leadership regarding emerging regulatory requirements, institutional risk, and compliance trends.
- Lead the continuous evaluation and enhancement of research compliance programs.
- Represent the University on institutional, provincial, and national committees.
- Develop strategic partnerships with affiliated hospitals, research institutes, government agencies, and external stakeholders.

Leadership and Management

- Provide leadership, supervision, coaching, mentoring, and performance management for professional compliance staff.
- Establish departmental goals, operational priorities, service standards, and performance metrics.
- Manage staffing plans, recruitment, succession planning, workload allocation, and professional development activities.
- Foster a cooperative, service-oriented culture.




- Lead organizational change initiatives and modernization efforts.

Research Ethics and Regulatory Collaboration

- Partner with REBs, affiliated hospitals, and institutional stakeholders.
- Lead resolution of complex compliance issues.
- Support harmonization of ethics review processes.
- Collaborate with legal counsel, privacy offices, risk management, and research administration.

Quality Assurance, Audit and Risk Management

- Develop and oversee the University's Quality Assurance and Research Compliance Monitoring Program.
- Lead preparation for inspections, audits, reviews, and accreditation processes.
- Direct internal audits and monitoring activities.
- Develop and oversee Corrective and Preventive Action (CAPA) plans.
- Report institutional compliance metrics and risk information to senior leadership.

Qualifications

Education

- Degree in Health Sciences, Regulatory Affairs, Bioethics, Law, Public Health, Clinical Epidemiology, or a related discipline.
- PhD or equivalent advanced professional designation is considered an asset.

Experience

- Minimum 8-10 years of progressively responsible experience in research compliance, clinical research administration, or regulatory affairs.




- Demonstrated experience leading multidisciplinary teams and managing complex compliance programs.
- Experience providing strategic advice to senior leadership and managing organizational risk.
- Significant experience interacting with Health Canada, Research Ethics Boards, sponsors, and regulatory agencies.
- Proven experience developing institutional policies, quality management systems, and compliance frameworks.
- Experience leading organizational change and continuous improvement initiatives.

Professional Certifications

- CCRP (SOCRA), CCRA (ACRP), or equivalent professional certification strongly preferred.
- Certification in Quality Management, Regulatory Affairs, Project Management, or Risk Management is considered an asset.

Skills and Abilities:

- Ability to interpret complex legislation and translate regulatory requirements into institutional policy.
- Strategic planning, organizational leadership, and change management expertise.
- Strong analytical, negotiation, and problem-solving abilities.
- Exceptional stakeholder engagement and relationship management skills.
- Demonstrated financial management, operational leadership, and resource planning experience.
- Ability to manage multiple priorities in a highly regulated environment.
- Ability to develop and implement operational procedures and process improvements.
- Strong leadership, team development, and coaching skills.
- Excellent verbal, written, interpersonal, organizational, and presentation skills.

How To Apply To apply for this job, please submit your application online.

📌 Associate Director, Clinical Research Operations (Canada)
🏢 McMaster University
📍 Canada