Position Details

Type Not Specified

Experience mid

Exp. Years 1-3 years

Education Bachelor's degree

Category Healthcare & Medical

About this role

Quality Assurance Specialist role focused on ensuring clinical study compliance with GCP, SOPs, and Federal/applicable regulations. The position performs document reviews and audits across trial materials and procedures, and supports corrective/preventive actions while helping train new staff.

Key Responsibilities

Review protocols, informed consents, and case report forms (CRFs) prior to study initiation and revisions
Conduct audits of study materials receipt/return/destruction and in-clinic procedures
Audit clinical trial master files, source data, and procedures for protocol/SOP/GCP/ICH compliance
Document non-conformities with corrective actions and preventive actions (CAPA)
Assist in auditing training files and train new departmental staff

Technical Overview

The work centers on GCP/ICH/GLP compliance for clinical trials: reviewing protocols, informed consents, CRFs, auditing clinical trial master files and source data, and verifying monitoring plan and SOP adherence. It also includes training support and documentation of non-conformities, CAPA, and final reporting review.

Ideal Candidate

The ideal candidate is a QA Specialist with a Bachelor’s degree and 1-3 years of relevant experience in clinical trial quality assurance. They have strong knowledge of Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and ICH/GLP guidelines, and can perform audits of clinical trial master files, source data, and study documentation with high attention to detail.

Must-Have Skills

Good Clinical Practices (GCP)Standard Operating Procedures (SOP)Federal and applicable regulationsDemonstrated ability to understand clinical studiesKnowledge of GCP ICH/GLP guidelines and Federal Regulations related to the conduct of Clinical TrailsNIH trainingBachelor's and min 1-3 years of relevant experienceExcellent organizationalattention to detailinterpersonal skillshigh level of multi-tasking capacities

Required Skills

Good Clinical Practices (GCP)Standard Operating Procedures (SOP)Federal and applicable regulationsclinical studiesinformed consentscase report forms (CRFs)auditclinical trial master filessource datamonitoring planFinal Reporttraining files auditingnon-conformitiescorrective actionspreventive actionslab safety

Hard Skills

Good Clinical Practices (GCP)Standard Operating Procedures (SOP)ICHICH complianceGLPFederal Regulationsclinical studies reviewinformed consentscase report forms (CRFs)audit of study material receipt and return/destructionin clinic audit of study proceduresclinical trial master filessource datamonitoring planFinal Reporttraining files auditingnon-conformities documentationcorrective actions (CAPA)preventive actions (CAPA)lab safetyequipment safetyhealth and safety reporting

Soft Skills

excellent organizational skillsattention to detailinterpersonal skillsmulti-tasking capacitiesstrong organizational skillsinterpersonal skillsability to work with all involved partiesprompt corrective actionencourage prompt reportingcommunication with international coordinators

Industry & Role

Industry Healthcare IT

Job Function Ensure clinical trial quality and compliance through documentation review and GCP/ICH/GLP audits.

Role Subtype QA Lead

Keywords for Your Resume

Quality Assurance SpecialistQA SpecialistGood Clinical Practices (GCP)GCPStandard Operating Procedures (SOP)SOPFederal RegulationsICHICH complianceGLPNIH trainingclinical studiesinformed consentscase report forms (CRFs)clinical trial master filessource datamonitoring planauditcorrective actionspreventive actionsnon-conformities

Deal Breakers

Bachelor's degree and minimum 1-3 years of relevant experience, Demonstrated ability to understand clinical studies, Knowledge of Good Clinical Practices (GCP) and ICH/GLP guidelines and Federal Regulations, Ability to perform audits of clinical trial master files and source data

Apply for this Position →

Get matched to jobs like this

Luna finds roles that fit your skills and career goals — no endless scrolling required.

Create a Free Profile