Compliance Lead

Centricity Research•Columbus, GA

About The Position

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.

Requirements

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
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
Excellent communication skills (verbal and written)
Excellent computer skills (MS Word, Excel and Outlook)
Attention to detail
Ability to manage time efficiently
Self-directed
Teamwork & Collaboration
Proficient level of clinical, interpretive, and analytical skills with organizational skills for project planning
Flexible & Adaptable
Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines
Conflict resolution
Receptive to feedback
Empowering & Developing others
Empathy Skills
Planning and organizing skills
Excellent problem-solving skills
Achievement oriented
Analytical ability
Initiative
Decision making
Forward thinking
Innovative
Creative
Strategic thinking
Self confidence
Strong interpersonal skills

Nice To Haves

Hold or are working toward ACRP or SOCRA certification (preferred)
ACRP or SOCRA certified Clinical Research Coordinator, preferred
2 years of clinical research experience at Centricity

Responsibilities

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