Job Description

Location : US-based, supporting Civia Health US sites (travel required)

Job Type:  Full-Time

Reports To : Head of US Delivery

Internal Team Title: Operational Compliance Specialist

 

Join Us at Civia Health

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.

Purpose of the Job

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.

Core Accountability

• 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

Key Responsibilities

1. Chart Quality Assurance and Source Data Verification

• 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

2. Protocol Deviation and Compliance Monitoring

• 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

3. Audit and Inspection Readiness

• 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

4. Data Integrity and Query Resolution Support

• 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

5. Cross-Functional Compliance Coordination

• 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

6. Site Staff Coaching and Compliance Education

• 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

Performance Measures (KPIs)

• Chart Review Completion Rate: 100% of assigned charts reviewed per cycle
• Source Data Verification Accuracy: Zero undetected discrepancies at audit
• Protocol Deviation Detection: Identified and documented within 24 hours of discovery
• Query Aging: Support site-level resolution within 7 days or less
• CAPA Closure: On-time closure of all assigned corrective actions
• Audit Findings: Zero critical findings attributable to chart quality or documentation gaps
• SAE Reporting Compliance: 100%

Ideal Phenotype

Mindset

• Quality-first orientation with a deep personal commitment to getting every detail right
• Proactive and investigative, naturally inclined to look for what others might miss
• Ownership mentality that treats compliance gaps as personal accountability, not someone else's problem

Behaviour

• Conducts thorough, methodical chart reviews without cutting corners
• Raises issues early and directly, providing clear documentation and recommended corrective actions
• Moves fluidly between site operations, quality, and data conversations with credibility in all three
• Coaches site staff with patience and clarity rather than policing from a distance

Capabilities

• 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

Personal Traits

• 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

Qualifications and Experience

• 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
• CCRC or CCRA certification preferred
• 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%)

Role Differentiation

The Operational Compliance Specialist is distinct from the VP of Quality (enterprise-level QA leadership) and from the Clinical Trial Manager (study delivery ownership). The OCS operates at the site and chart level, providing the hands-on quality oversight that ensures every participant record, every source document, and every data entry meets the standard before it reaches a monitor or auditor. This role fills the critical gap between organizational quality strategy and daily site execution.

Executive One-Liner

The OCS is Civia Health's site-level quality expert, ensuring every chart, every source document, and every data point is audit-ready before anyone outside the site ever sees it.

CIVIA HEALTH VALUES IN ACTION

• Empathy: Approach site staff with understanding, meeting them where they are to elevate quality together.
• Integrity: Hold the line on compliance, even when it means flagging uncomfortable findings.
• Trust: Build confidence through thoroughness, consistency, and follow-through on every review.
• Community: Collaborate across QA, data, and site ops to strengthen the collective standard.
• Relentless Self-Improvement: Stay current on regulatory changes, refine review methodologies, and continuously raise the bar.

WHY CIVIA HEALTH

Join a purpose-driven organization redefining clinical research by connecting science with humanity. As part of our quality and operations team, you will play a direct role in ensuring the integrity of clinical trial data, protecting patient safety, and maintaining the standards that earn and sustain sponsor confidence.

Job Tags

Full time, Immediate start

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