Join Us at Centricity Research!
Centricity Research is one of the largest clinical research networks in North America. We are a fully centralized Integrated Research Organization (IRO) specializing in conducting Phase I-IV clinical trials in over 35 therapeutic areas: inpatient and outpatient; pharmaceutical, biotechnology, and medical device trials.
About the Role
We are seeking a Compliance Lead to support the safety, rights, and well-being of study participants while ensuring the quality and integrity of clinical trial operations across assigned sites. This role provides oversight of compliance activities, mentors quality-support staff, and partners closely with Clinical Operations, Training & Development, and Research Management to proactively identify risk and maintain audit readiness.
The Compliance Lead plays a critical role in upholding adherence to study protocols, ICH/GCP, Centricity SOPs, and regulatory requirements, while driving continuous improvement across clinical trials.
What You’ll Do
- Ensure the safety and welfare of study participants by upholding ICH/GCP standards and regulatory requirements
- Maintain strong working knowledge of study protocols, Centricity SOPs/WPs, and applicable regulations
- Ensure completeness and compliance of study documentation, including source documents, CRFs, and the Investigator Site File (ISF)
- Confirm appropriate and consistent oversight by the Qualified Investigator
- Review protocol deviations for completeness and IRB reporting; determine CAPAs, additional training needs, and escalate systemic issues as needed
- Review AEs and SAEs for accuracy, completeness, and timely reporting
- Track and review monitoring follow-up reports to ensure appropriate risk assessment and timely closure of findings
- Liaise with CRAs, Sponsors, CROs, and external partners regarding site quality and study status
- Conduct internal audits using risk-based principles and support audit follow-up activities
- Lead preparation and readiness for inspections and audits (FDA, Health Canada, Sponsor/CRO, and internal)
- Perform mock emergency drills with key CPU staff and support real-time (“live”) QC for high-risk trials
- Support onboarding and ongoing training initiatives; complete new-hire quality check-ins and assigned quarterly check-ins
- Identify and escalate training needs to the Clinical Training Administrator
- Maintain and update Research SOPs and WPs in collaboration with Research Management and the Senior Quality Manager
- Support responses to FDA 483s or Health Canada observations, including documentation and procedure updates
- Perform vendor audits as required
- Assist CRCs with standardized Site Initiation Visit (SIV) preparation
- Partner cross-functionally to support quality standards, site performance, and continuous improvement initiatives
You Might Be a Great Fit If You:
- Have a bachelor’s degree in science or a related field, or equivalent experience
- Bring at least two years of clinical research experience (e.g., CRC, QA/QC, regulatory, monitoring, or similar)
- Possess strong knowledge of ICH/GCP, clinical trial processes, and regulatory requirements
- Have experience reviewing study documentation, deviations, AEs/SAEs, and monitoring follow-up reports
- Have prior exposure to audits, inspections, or quality assurance activities
- Hold or are working toward ACRP or SOCRA certification (preferred)
- Demonstrate a strong quality and compliance mindset with exceptional attention to detail
- Think critically, assess risk effectively, and recommend practical corrective actions
- Communicate clearly and professionally with site staff, monitors, regulators, and leadership
- Enjoy mentoring others and supporting staff development
- Are highly organized and able to manage multiple priorities and deadlines
- Work well independently while collaborating across Clinical Operations, Training, and Research Management
- Adapt easily to changing trial requirements and regulatory expectations
- Are motivated by continuous improvement and strengthening operational quality
Why Centricity Research?
Our Mission
We connect people to scientific advancements through groundbreaking research within a deeply human experience.
Our Core Values
- Quality: We aim for excellence and integrity in everything we do - because lives depend on it.
- Care: We show up for each other, our customers, and our mission - always going the extra mile.
- Be the Change You Seek: We're adaptable, forward-thinking, and constantly improving - for the betterment of all.
- One Team: We collaborate, support one another, and succeed together.
- Grow for Good: We grow with purpose - to expand access to research and improve global health.
- Own It: We take initiative, deliver results, and follow through - with passion and accountability.
Benefits
- Comprehensive health, dental, and vision insurance
- Enhanced EAP – mental health support
- Flexible PTO + paid holidays
- Continuing education reimbursement
- 401(k) / RRSP with company match and immediate vesting
Ready to Apply?
We’d love to hear from you – apply now!
We’re an equal opportunity employer committed to building a diverse and inclusive workplace. We welcome applicants from all backgrounds and will provide accommodations during the hiring process upon request.
