Clinical Research · Data · Vienna

Judith
Lavric

Clinical Research Associate transitioning into Clinical Data Management — combining 3+ years of hands-on GCP experience with growing expertise in data analysis and digital health systems.

View Experience Get in Touch
3+
Years in Clinical Research & Documentation
4
Clinical & Hospital Settings
100%
Audit & Inspection Readiness Record
About

Where Clinical Expertise
Meets Data

I am a detail-oriented healthcare professional with a background spanning clinical documentation, source data verification (SDV), regulatory compliance, and site coordination. My career has been built in high-stakes hospital environments where accuracy is non-negotiable.

Currently completing a BSc in Biotechnology (Sept 2026), I am actively transitioning into the intersection of clinical research and data — building skills in Python, SQL, and clinical data systems to complement my deep understanding of GCP workflows.

I am fluent in German (C2) and English (C1), remote- and travel-ready across Europe, and available immediately for CRA or Clinical Data roles.

ICH-GCP E6 R2/R3 ISO 14155 MDR EU 2017/745 FDA 21 CFR Part 11 GDPR Veeva Vault SAP / ELGA
Email [email protected]
Phone +43 699 1800 9026
Location Vienna, Austria
Availability Immediately available
Mobility Remote & travel-ready / Europe
Languages German C2 · English C1
Experience

Professional Timeline

Feb 2024
— Present
Clinical Research & Medical Documentation Assistant
Hospital of the Brothers of Mercy — Vienna, Austria
  • Performed source data verification (SDV) and QC reviews of patient records and anesthesia documentation, ensuring compliance with ICH-GCP, ISO 14155, and internal SOPs.
  • Executed structured data entry into SAP and ELGA (EHR) systems, mirroring EDC/eCRF workflows with focus on data integrity, traceability, and query resolution.
  • Maintained essential clinical documents within eTMF-equivalent archiving systems, ensuring 100% inspection and audit readiness.
  • Identified documentation discrepancies and protocol deviations; escalated findings in line with CRA-style monitoring workflows.
  • Ensured full GDPR-compliant handling of sensitive patient health information.
Oct 2023
— Feb 2024
Laboratory Assistant & Clinical Data Associate
Allergy Outpatient Clinic — Vienna, Austria
  • Processed, centrifuged, and documented biological samples (blood, serum) per laboratory SOPs, maintaining chain-of-custody standards consistent with clinical trial sample management.
  • Transcribed and verified laboratory results for clinical reporting, applying QC data entry checks analogous to EDC source data verification.
  • Maintained audit-ready sample tracking logs and supported preparation for internal quality audits.
Nov 2022
— Sep 2023
Ward Supervisor & Clinical Coordinator — Infectious Diseases
University Medical Center Mainz — Mainz, Germany
  • Coordinated interdisciplinary physician rounds and daily clinical briefings, ensuring procedural compliance and complete, timely documentation.
  • Supervised clinical workflows, delegated tasks, and monitored SOP adherence across a multidisciplinary team — aligned with CRA site-oversight responsibilities.
  • Onboarded and trained new clinical staff on documentation standards and internal procedures.
  • Performed venipuncture and managed related laboratory documentation and sample tracking.
Jun 2022
— Sep 2023
Emergency Medical Staff
University Medical Center Mainz — Mainz, Germany
  • Managed accurate, timely patient record documentation in high-pressure emergency settings, demonstrating composure and prioritization under clinical pressure.
Competencies

Core Skills

🔬
Clinical Research
  • ICH-GCP E6 R2/R3
  • Risk-Based Monitoring (RBM)
  • Site Initiation / Close-Out Visits
  • Source Data Verification (SDV)
  • AE/SAE Documentation
  • Protocol Deviation Management
  • ICF Review & Pharmacovigilance
📋
Regulatory & Compliance
  • ISO 14155 · MDR EU 2017/745
  • FDA 21 CFR Part 11
  • EMA Regulations · GDPR
  • SOP Development & QA/QC
  • Audit & Inspection Readiness
  • CAPA Awareness
  • eTMF / TMF Management
💻
Technical Systems
  • Veeva Vault (eTMF)
  • SAP · ELGA (EHR)
  • EDC / eCRF Platforms
  • CTMS (familiar)
  • MS Office 365
  • Python
  • SQL
Portfolio Project

Data Analysis Work

Clinical Data Analysis · Python · CDISC SDTM
Adverse Events Analysis — CARDIO-2024 Trial

A Python-based analysis of adverse event data from a simulated Phase II cardiovascular clinical trial, structured according to CDISC SDTM standards. Automated AE classification, severity distribution, SAE flagging, and patient review identification — replacing manual Excel-based review.

Python Pandas Matplotlib CDISC SDTM AE Classification Data QC
View Full Project →
AE SEVERITY DISTRIBUTION · N=23
Mild
12
Moderate
6
Severe
5
PATIENTS FLAGGED FOR REVIEW
PT-004
4 AEs
PT-002
3 AEs
PT-007
3 AEs
Education

Academic Background

Medical Specialist Training
Medizinische Fachangestellte (MFA)
Formal clinical training covering patient documentation, laboratory procedures, regulatory compliance, and healthcare workflows in medical settings.
ICH-GCP Certification
Good Clinical Practice · E6 R2/R3
In-depth knowledge of GCP guidelines governing the conduct of clinical trials, including subject protection, data integrity, and audit readiness standards.
Regulatory Frameworks
ISO 14155 · MDR · FDA 21 CFR Part 11
Practical working knowledge of EU and US regulatory requirements for clinical research, medical devices, and electronic record management.