Associate Director, Clinical Research Operations

Title: Associate Director, Clinical Research Operations

Company: McMaster University
Location: Hamilton, ON
Job Type: FlexTime, FullTime, PartTime, Weekdays

Description:

McMaster University is seeking an Associate Director, Clinical Research Operations to provide strategic leadership in the health research services department. The ideal candidate will have a graduate degree in a related field and 8-10 years of experience in clinical research administration or regulatory affairs. The position involves overseeing regulatory compliance, developing policies, managing staff, and fostering a culture of continuous improvement.

The Associate Director will be responsible for ensuring institutional compliance with various regulations and standards governing human participant research. They will provide expert advice to senior leadership, researchers, and external stakeholders, and oversee the University's clinical research operations portfolio. The role involves strategic leadership, operational management, and collaboration with research ethics boards and regulatory agencies.

Key responsibilities include developing the University's strategic vision for clinical research operations, providing leadership and management for compliance staff, ensuring compliance with regulatory requirements, and overseeing quality assurance, audit, and risk management activities. The ideal candidate will have a degree in a related discipline, 8-10 years of experience, and professional certifications in research compliance or related fields.

The successful candidate will have expert knowledge of various regulations and standards, strong leadership and management skills, and the ability to interpret complex legislation. They will also possess excellent communication, problem-solving, and stakeholder engagement skills. The position offers a competitive salary range and the opportunity to contribute to McMaster University's health research enterprise.

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Title: Associate Director, Clinical Research Operations
Company: McMaster University
Location: Hamilton, ON
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  
FullTime  
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, MondayFriday, 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 810 years of progressively responsible experience in clinical research administration, research compliance, regulatory affairs, or a related field.

Job Description

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 highimpact 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, TriAgency 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 investigatorinitiated, industrysponsored, and multisite 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, serviceoriented 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

ICHGCP

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 decisionmaking.

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 closeout.
 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

ICHGCP

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 professional designation is considered an asset.

Experience

Minimum 810 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
 ICHGCP
 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 problemsolving 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 decisionmaking 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 selfidentification in relation to equityseeking 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 9055259140 ext. 222HR (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 onsite 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 inperson, 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 thirdparty 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.

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