Clinical Research QA Specialist

Saratoga Ascend

. Develop and maintain monitoring SOPs and quality management documents .

Posted 11/5/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality assurance and clinical research, with a strong focus on Good Clinical Practice (GCP) and regulatory compliance. Proficient in developing SOPs, conducting audits, and delivering training to ensure adherence to NIH and FDA standards.

Highest-signal resume keywords

Quality Assurance CertificationGCP Quality FunctionsRegulatory ComplianceClinical Research ExperienceAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ManagementMonitoring SOP DevelopmentCAPA TrackingInternal AuditsGCP TrainingDocumentation ReviewRegulatory File ReviewCorrective Action EffectivenessClinical Research ProtocolsMultidisciplinary Team Collaboration

Soft Skills

Analytical SkillsCommunication SkillsDocumentation Skills

Certifications & Qualifications

QA CertificationCQARQAP-GCPCurrent GCP Training

Industry Keywords

Good Clinical PracticeNIH-Regulated StudiesFDA-Regulated Studies21 CFR Parts 11, 50, 54, 56, 312, 81245 CFR Part 46HIPAAHuman Subjects Protections

About the role

Key responsibilities & impact

Develop and maintain monitoring SOPs and quality management documents
Conduct quality review of monitoring reports, essential documents and regulatory files
Track and verify CAPA and the effectiveness of corrective actions
Conduct or support internal audits and inspection readiness activities
Deliver GCP and protocol training for clinical research staff

Requirements

What you’ll need

Bachelor's degree in a life science or related field
QA certification (e.g., CQA, RQAP-GCP) preferred
Minimum of 5 years of quality assurance or clinical research experience
At least 3 years in GCP quality functions for NIH- or FDA-regulated studies
Strong analytical, documentation and communication skills
Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs
Working knowledge of Good Clinical Practice (ICH E6)
Working knowledge of 21 CFR Parts 11, 50, 54, 56, 312 and 812, as applicable
Working knowledge of 45 CFR Part 46 and HIPAA
Current human subjects protections and GCP training (e.g., CITI or equivalent)
Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials

Benefits

Comp & perks

Competitive rate
Benefit options
Equal opportunity employment