Clinical Compliance Specialist

JenaValve Technology, Inc.

Specialist, Clinical Compliance managing audit logistics and compliance metrics. Collaborating across Clinical Affairs and Quality to support clinical compliance program.

Posted 7/28/2026full-timeRemote • California • 🇺🇸 United StatesJuniorMid-Level💰 $80,000 - $90,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical research and operations, with a strong focus on compliance with ICH E6 GCP guidelines and FDA regulations. Proficient in managing CAPAs, non-conformances, and audit corrective actions while supporting continuous process improvement initiatives.

Highest-signal resume keywords

Clinical Research ExperienceKnowledge of ICH E6 GCP GuidelinesCAPA ManagementStrong Organizational SkillsExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical OperationsAudit PlanningCompliance Metrics ManagementProcess ImprovementVendor Qualification

Soft Skills

Attention to DetailOrganizational SkillsWritten CommunicationVerbal Communication

Industry Keywords

FDA RegulationsISO 14155Clinical Quality AssuranceCAPANon-Conformance

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support audit planning and execution for internal and investigational site audits
Enter, track, and monitor CAPAs, non-conformances, and audit corrective actions
Support vendor qualification activities for CROs, core labs, and other clinical service providers
Maintain compliance metrics dashboards
Support continuous process improvement and other clinical affairs deliverables as needed

Requirements

What you’ll need

2+ years in clinical research, clinical operations, or clinical quality assurance
Bachelor's degree or higher in life sciences, health sciences, or a related field required
Working knowledge of ICH E6 GCP guidelines and FDA regulations
Familiarity with ISO 14155 preferred
Strong organizational skills and attention to detail
Excellent written and verbal communication skills

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options