Quality Specialist (Clinical Research QC Reviewer)
New
U
UniTriTeamClinical Research
Buenos Aires, Argentina, CST (Central Standard Time)ContractMiddle
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum three (3) years of clinical research experience
- Required Skills
- Quality Assurance
Requirements
- Minimum three (3) years of clinical research experience.
- Previous experience as a Clinical Research Coordinator (CRC), Regulatory Specialist, Clinical Research Associate (CRA), or similar role.
- Strong understanding of ICH-GCP, protocol compliance, and protocol deviations.
- In-depth knowledge of source documentation standards and ALCOA/ALCOA+ principles.
- Previous experience reviewing source documentation.
- Prior experience conducting Quality Control (QC) or Quality Assurance (QA) reviews in clinical research (strongly preferred).
- Experience with CRIO or other eSource platforms (preferred).
- Experience supporting sponsor audits or regulatory inspections (preferred).
- Associate's or Bachelor's degree in a healthcare, life sciences, or nursing field preferred.
- Extreme attention to detail and strong critical thinking skills.
- Ability to work independently in a structured, checklist-driven environment.
Responsibilities
- Review completed participant visits within the CRIO eSource platform using established quality control processes.
- Verify that all protocol-required procedures, assessments, and documentation have been completed accurately.
- Evaluate documentation against ALCOA and ALCOA+ principles to ensure data integrity.
- Identify missing documentation, inconsistencies, protocol deviations, and transcription errors.
- Complete standardized QC Checklists to ensure consistency across studies.
- Document findings thoroughly and escalate significant quality issues.
- Collaborate with site personnel to communicate findings and support timely resolution.
- Monitor corrective actions and follow-up activities as assigned.
View Full Description & ApplyYou'll be redirected to the employer's site
