Clinical Quality Monitor

Civia Health

1d•Remote

About The Position

Civia Health operates a next-generation SMO model designed for predictable, high-quality clinical trial delivery. Our approach depends on seamless alignment across specialized functions, supported by disciplined governance, transparency, and performance accountability. Within this model, the Operational Compliance Specialist (OCS) serves as the site-level quality expert and compliance bridge between site operations, quality assurance, and data management. The OCS ensures that every chart, every source document, and every data point meets sponsor expectations and regulatory standards before they ever reach an auditor. The OCS provides hands-on, site-level quality oversight for assigned clinical trial sites. This role fills a critical gap between enterprise-level QA and day-to-day site operations by embedding compliance expertise directly into the site workflow. The OCS conducts ongoing chart quality reviews, identifies documentation gaps and protocol deviations in real time, and works with site staff to resolve issues before they become audit findings. Where the VP of Quality sets organizational standards and manages enterprise compliance programs, the OCS executes quality at the ground level, ensuring that every participant record at every site reflects the rigor and accuracy Civia Health demands.

Requirements

Bachelor's degree in life sciences, nursing, health sciences, or related field
Minimum 3 years of clinical research experience with direct CRA, clinical monitoring, or site-level QC responsibilities
Demonstrated experience with source data verification, chart review, and regulatory compliance in Phase III/IV trials
Familiarity with FDA inspection and sponsor audit processes
Willingness to travel to assigned US sites (estimated 40-60%)
Prior CRA, clinical monitor, or site QC experience with demonstrated source data verification expertise
Strong working knowledge of GCP/ICH guidelines, FDA regulations, and sponsor audit expectations
Skilled in chart review methodology, deviation classification, and CAPA development
Comfortable with EDC/eCRF systems (CRIO experience a plus) and clinical trial management tools
Analytical mindset with the ability to identify patterns in deviation data and translate findings into actionable site improvements
Meticulous, detail-obsessed, and unflinching about documentation accuracy
Trustworthy and discreet when handling sensitive compliance matters
Resilient and composed under audit pressure
Collaborative, approachable, and effective at building trust with site staff

Nice To Haves

CCRC or CCRA certification preferred

Responsibilities

Full accountability for chart-level quality assurance and source data integrity across assigned US sites
Serve as the frontline quality checkpoint, catching compliance gaps before they surface in sponsor audits or monitoring visits
Maintain real-time visibility into protocol deviations, documentation deficiencies, and CRF/eCRF accuracy at the site level
Drive immediate corrective action when quality issues are identified, coordinating with site staff, data management, and QA
Ensure ongoing audit and inspection readiness through proactive chart reviews, regulatory binder checks, and compliance monitoring
Act as the operational bridge connecting site teams, quality assurance, and data compliance with clear accountability at every step
Conduct ongoing, systematic chart reviews across assigned sites to verify accuracy, completeness, and protocol compliance
Perform source data verification (SDV) to confirm that CRF/eCRF entries match source documentation
Identify and document discrepancies, missing data, and incomplete consent or eligibility documentation
Maintain a chart review tracker with findings, trends, and resolution status for each site
Monitor site activities for protocol deviations, GCP non-compliance, and documentation gaps in real time
Classify deviations by severity and ensure timely reporting, documentation, and corrective action
Track deviation trends across sites and escalate recurring patterns to QA and site leadership
Support root cause analysis and corrective/preventive action (CAPA) development at the site level
Maintain assigned sites in a state of continuous audit readiness through proactive compliance reviews
Conduct pre-audit preparation activities including mock chart reviews, regulatory binder walkthroughs, and staff readiness assessments
Support sponsor audits and regulatory inspections by serving as the site-level quality point of contact
Track and ensure timely closure of audit findings and CAPA commitments
Partner with the data management team to ensure timely and accurate query resolution at the site level
Review query aging trends and work with site coordinators to reduce open query backlogs
Verify data entry timeliness and accuracy, flagging systemic issues to site leadership and data compliance
Support clean patient database objectives by ensuring site-level data hygiene standards are met
Serve as the connective tissue between site operations, QA, and data management on all compliance matters
Participate in cross-functional quality meetings, providing site-level findings and trend analysis
Coordinate with the VP of Quality on enterprise QA initiatives, translating organizational standards into site-level execution
Communicate compliance status, risks, and recommended actions to the Head of US Delivery
Provide real-time coaching to site coordinators, investigators, and research staff on documentation standards and GCP requirements
Support training initiatives by identifying knowledge gaps revealed through chart reviews and deviation trends
Reinforce a culture of quality and accountability at every site through consistent engagement and follow-through