Job ID
77938
Job Title
Associate Director, Clinical Research Operations
Regular/Temporary
Regular
Location
HSC- Central Campus
Open Date
2026/08/10
Job Type
Continuing
Close Date
2026/08/19
Employee Group
TMG
Favorite Job
Department
Health Research Services
Full/Part Time
Full-Time
Salary Grade/Band
Band M
Salary Range
$103826.00 - $155740.00 (annual)
Job Code
104863
Hiring Range
$103826.00 - $136142.00
Existing Vacancy
Yes - Newly Created Position
Target Number of Openings
1
Hours per Week
35
Posting Details
Schedule
35 hours per week, Monday-Friday, Hybrid Accommodation.
Education Level
Graduate degree in Health Sciences, Public Health, Regulatory Affairs, Bioethics, Law, Clinical Epidemiology, Health Administration, or a related field.
Career Level
Minimum 8-10 years of progressively responsible experience in clinical research administration, research compliance, regulatory affairs, or a related field.
Department Description
McMaster University, Faculty of Health Sciences is a leader in health research and innovation, providing a dynamic and collaborative environment for researchers and professionals.
The Associate
Director, Clinical Research Operations position is a high-impact leadership role requiring a strong strategic mindset, expertise in research, clinical research standard practices and application requirements, and exceptional leadership capabilities to support and advance McMaster's health research enterprise.
FHS Health Research Services provides leadership, counsel, and fundamental services to the health research community. These efforts help ensure the eligibility of McMaster's research community to obtain health research funding from federal and provincial governments, funding agencies, and sponsors by ensuring compliance with internal and external regulations and policies, particularly those relating to human and animal research ethics, biohazards, and environmental regulations. The result is the maximization of available project and program funding opportunities for McMaster's health researchers.
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.
The Associate Director provides leadership under the auspices of McMaster University, overseeing regulatory compliance for investigator-initiated, industry-sponsored, and multi-site clinical research. The position serves as the University's senior institutional resource for clinical research compliance matters, providing expert advice to senior leadership, researchers, research ethics boards, hospital partners, regulatory agencies, and external sponsors.
The Associate Director is responsible for establishing strategic priorities, managing operational resources, developing institutional policies and standard operating procedures, identifying and mitigating institutional risk, and fostering a culture of regulatory excellence and continuous quality improvement.
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 collaborative, service-oriented culture.
- Lead organizational change initiatives and modernization efforts.
Institutional Research Compliance Oversight
- Provide institutional oversight for all clinical research conducted under the auspices of McMaster University.
- Ensure institutional compliance with:
- TCPS 2
- Health Canada Food and Drugs Act and Regulations
- Division 5 Clinical Trial Regulations
- Medical Device Regulations
- ICH-GCP
- PHIPA
- Applicable provincial and federal privacy legislation
- Monitor evolving regulatory requirements and implement compliance strategies.
- Serve as the institutional authority for complex regulatory interpretation and compliance decision-making.
Clinical Research Regulatory Oversight
- Provide strategic oversight of Health Canada submissions and regulatory filings.
- Ensure institutional compliance with regulatory reporting requirements.
- Develop institutional procedures governing clinical trial initiation, monitoring, reporting, and close-out.
- Provide expert consultation to investigators and research teams throughout the clinical trial lifecycle.
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.
Policy Development and Continuous Improvement
- Lead development and review of institutional compliance policies, procedures, and SOPs.
- Ensure policies remain aligned with evolving legislation and standards.
- Identify opportunities to improve research administration processes.
- Champion quality improvement initiatives.
Education and Institutional Capacity Building
- Develop and implement education programs for faculty, staff, students, and administrators.
- Provide leadership for training related to:
- TCPS 2
- ICH-GCP
- Health Canada Regulations
- Responsible Conduct of Research
- Promote a culture of compliance, accountability, and continuous learning.
Operational Management
- Monitor resource utilization and identify efficiencies.
- Participate in strategic planning activities.
- Oversee compliance systems and technology implementation.
- Establish operational dashboards and performance indicators.
Qualifications
Education
- Degree in Health Sciences, Regulatory Affairs, Bioethics, Law, Public Health, Clinical Epidemiology, or a related discipline.
- PhD or equivalent advanced skilled 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.
Knowledge, Skills and Abilities
Expert Knowledge of:
- TCPS 2
- Food and Drugs Act and Regulations
- Health Canada Division 5 Clinical Trial Regulations
- ICH-GCP
- PHIPA and applicable privacy legislation
- Responsible Conduct of Research Framework
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.
- Sound judgment and decision-making capabilities.
- Ability to work independently with minimal supervision.
- Demonstrated diplomacy and a collegial approach.
- Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint.
- Knowledge of University policies and regulatory frameworks governing clinical research operations. Ability to organize and facilitate workshops, education sessions, and stakeholder engagement activities.
Pay Transparency Statement The posted hiring range represents McMaster's typical hiring range for this position. Actual starting salary will depend on factors such as relevant experience, qualifications, internal equity, and market conditions. Individuals with extensive experience, deep specialized expertise, and/or those who can demonstrate exceptional past performance, as applicable, may be hired at a higher rate within the full range, in accordance with the University compensation policies.
How To Apply To apply for this job, please submit your application online.
Employment Equity Statement
McMaster University is located on the traditional territories of the Haudenosaunee and Mississauga Nations and within the lands protected by the “Dish With One Spoon” wampum agreement.
The diversity of our workforce is at the core of our innovation and creativity and strengthens our research and teaching excellence. In keeping with its Statement on Building an Inclusive Community with a Shared Purpose, McMaster University strives to embody the values of respect, collaboration and diversity, and has a strong commitment to employment equity.
The University seeks qualified candidates who share our commitment to equity and inclusion, who will contribute to the diversification of ideas and perspectives, and especially welcomes applications from indigenous (First Nations, Métis or Inuit) peoples, members of racialized communities, persons with disabilities, women, and persons who identify as 2SLGBTQ+.
As part of McMaster’s commitment, all applicants are invited to complete a confidential Applicant Diversity Survey through the online application submission process. The Survey questionnaire requests voluntary self-identification in relation to equity-seeking groups that have historically faced and continue to face barriers in employment. Please refer to the Applicant Diversity Survey - Statement of Collection for additional information.
Job applicants requiring accommodation to participate in the hiring process should contact:
- Human Resources Service Centre at (phone hidden) ext. 222-HR (22247), or
- Faculty of Health Sciences HR Office at ext. 22207, or
- School of Graduate Studies at ext. 23679
to communicate accommodation needs. Vaccination Mandate - FHS
This position is located in a host hospital or other healthcare site that has an active vaccination mandate in place. Successful applicants will need to comply with these and any other health and safety measures necessary as part of their appointment.
Hybrid Work Language To ensure an ongoing and vibrant University community that meets the needs of our students, staff and faculty and supports the University mission, ability to work on-site continues to be a requirement for most University positions. The University is supportive of exploring flexible work arrangements that effectively balance operational needs and employee interests.
Interview Experience
At McMaster University, we believe in a comprehensive and inclusive interview process. Our interview methods encompass a variety of approaches that allow our hiring teams to provide a flexible and accessible experience for engaging with our candidates. Throughout your recruitment process at McMaster, you may be requested to participate in a variety of formats, that may include in-person, virtual or recorded interviews.
If you have any questions as you move through the hiring process, please reach out to
[email protected] or the HR contact associated with your position of interest.
AI Statement
McMaster and its third-party partners may use AI tools to screen, assess, or select applicants during the hiring process. Please note that currently our recruitment platform does not use AI nor is it part of our current recommended recruitment process.
📌 Associate Director, Clinical Research Operations (Canada)
🏢 McMaster University
📍 Canada