Clinical Research Lead

JOB DESCRIPTION, CLINICAL RESEARCH LEAD

STATUS: Contracted Position

JOB START DATE: 01 August 2026

LOCATION: Virtual position

1.0. COMPANY

Changemark Research + Evaluation is a women-owned, social-purpose Contract Research Organization (CRO) specializing in clinical research, substance use, mental health, and Indigenous health and wellness. We are committed to conducting ethical, participant-centred, and scientifically rigorous research that creates meaningful impact for communities.

Our work is guided by values of integrity, equity, collaboration, and respect for lived experience. We partner with sponsors, sites, communities, and participants to deliver high-quality clinical trials while ensuring participant safety, data quality, and operational excellence.

At Changemark, we believe the best research is built through diverse expertise and strong relationships. Our team-based approach brings together skilled professionals who are passionate about advancing evidence-based solutions and improving health outcomes through research.

2.0 JOB SUMMARY

We are seeking an experienced Clinical Research Lead to oversee and support the delivery of clinical trials across a range of therapeutic areas, including psychedelics, cannabis, opioids, stimulant use, depression, post-traumatic stress disorder (PTSD), anxiety disorders, and substance use disorders.

As a key member of our growing social-purpose CRO, the Clinical Research Lead will be responsible for leading trial operations, supporting sponsors and study teams, and ensuring the successful execution of high-quality, participant-centred research. In addition to study oversight, this role will work closely with the CEO and QA Lead to help build and strengthen Changemark’s clinical research infrastructure, systems, processes, and operational capabilities as we continue to expand our clinical trials program.

2.0 KEY RESPONSIBILITIES

1. Clinical Operations Leadership

• Provide operational oversight across all active clinical trials and clinical research projects.
• Serve as the primary escalation point for Project Managers.
• Monitor study performance, timelines, budgets, risks, and resource utilization.
• Lead portfolio review meetings and ensure alignment across projects.
• Support study start-up, execution, and close-out activities.
• Ensure consistent operational standards across all studies.

2. Clinical Infrastructure Development

• Design, implement, and maintain Changemark’s clinical operations infrastructure.
• Develop and optimize Standard Operating Procedures (SOPs), templates, tools, and workflows.
• Continue the development of scalable systems for:
• Study start-up
• Site management
• Monitoring
• Risk management
• Vendor oversight
• Trial master file management
• Quality management
• Study close-out
• Lead implementation and optimization of technology infrastructure for the clinical program.

3. Project Manager Oversight

• Supervise and mentor all Project Managers.
• Establish project management standards and best practices.
• Review project workplans, timelines, budgets, and risk registers.
• Ensure Project Managers are appropriately resourced and supported.
• Conduct regular performance coaching and professional development.
• Promote consistency in sponsor communications and project delivery.

4. Quality and Compliance

• Collaborate with Quality Assurance leadership to maintain compliance with:
• ICH-GCP
• FDA regulations
• Health Canada regulations
• Sponsor requirements
• Internal SOPs
• Support audit and inspection readiness.
• Lead operational CAPA implementation when required.
• Monitor protocol deviations, quality metrics, and operational risks.
• Ensure documentation standards are consistently maintained.
• Oversee and monitor vendor performance

5. Business Development Support

• Participate in proposal development and bid defense meetings.
• Review operational feasibility and study execution plans.
• Develop clinical operations budgets and staffing models.
• Support sponsor relationship management activities.
• Identify opportunities for service expansion and process improvement.

6. Vendor and Partner Oversight

• Oversee operational relationships with:
• Monitoring vendors
• Data management vendors
• Regulatory vendors
• Laboratories
• Pharmacy and IMP providers
• Technology vendors
• Ensure vendor performance meets contractual and operational expectations.
• Support vendor selection and qualification activities.

7. Strategic Leadership

• Contribute to Changemark’s strategic growth as a leading social-purpose CRO.
• Identify opportunities to improve efficiency, quality, and scalability.
• Support development of new service offerings.
• Champion participant-centered, trauma-informed, and equity-focused approaches to clinical research.
• Foster a culture of collaboration, accountability, innovation, and continuous improvement.

3.0 QUALIFICATIONS

· Bachelor’s degree in health sciences, clinical research, nursing, public health, or related discipline.

· Minimum 5-7 years of clinical research experience.

· Experience managing multi-site clinical trials.

· Experience supervising project teams.

· Strong knowledge of ICH-GCP, FDA, and Health Canada requirements.

· Experience with CRO and sponsor environments.

· Experience implementing operational systems and processes.

· Training in Good Clinical Practice (GCP) and Ethical Conduct for Research Involving Humans (TCPS-2)

· Certified Clinical Research Professional (CCRP) or Association of Clinical Research Professionals (ACRP) certification an asset

· Knowledge and/or experience working alongside people with lived experience

· Knowledge and/or experience working in partnership with Indigenous Peoples and understanding of cultural humility, anti-racism, and OCAP principles.

· Excellent interpersonal, organizational, and written communication skills

4.0 COMPENSATION

This is a contracted position 30 hours per week at $6500 per month. The term of this position is 12 months. No fixed work hours, flexible as per needs of the project.

Start date: 01 August 2026

End date: 30 July 2027

5.0 REPORTING STRUCTURE

Reports to: Chief Executive Officer and Direct Reports, Project Managers, and clinical operations contractors and employees

CONTACT:

c/o Changemark Research + Evaluation Ltd.

Email: admin@changemark.ca

APPLICATION DEADLINE: 10 July 2026

To apply for this position, please e-mail your CV to admin@changemark.ca and include "Changemark- Clinical Research Lead" in the subject line. Please save any attachments as one file and be named: "Your Full Name – Clinical Research Lead, Changemark". We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.

Work Location: Remote