Summary
Overview
Work History
Education
Skills
Certification
Languages
Languages
Timeline
Christina Muntean

Christina Muntean

Conroe,TX

Summary

A foreign medical school graduate with over three years of hands-on experience as a medical resident in diverse healthcare settings (inpatient, outpatient, ER, OR).

Experience as a Senior Clinical Research Coordinator, specializing in study management and oversight while ensuring compliance with protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines.

Overview

7
7
years of professional experience

Work History

Senior Clinical Research Coordinator

DM Clinical Research
01.2022 - 03.2025

Managed and oversaw clinical trials from start-up to close-out, ensuring data quality, compliance with protocols, GCP, and regulatory requirements. GCP, and regulatory requirements. Coordinated and maintained regulatory documentation, handled patient safety monitoring, and addressed adverse events and deviations. Managed informed consent processes, internal audits, and EDC systems. Conducted study subject visits, ensured adherence to data collection guidelines, and resolved queries. Supported the Principal Investigator and research team with daily activities, and assisted with various trial-related tasks.

Medical Resident

University Emergency Hospital Bucharest - SUUB
Bucharest
01.2020 - 12.2020

Provided patient care by assessing, diagnosing, and treating under supervision, including physical exams, medical history collection, and treatment planning. Assisted with pre- and post-operative care, performed medical procedures like vital sign checks, blood draws, and suturing, and documented patient progress. Participated in daily rounds, conducted procedures in various settings, and educated patients and families on treatment plans. Collaborated with the healthcare team, participated in on-call shifts, and engaged in ongoing professional development. Contributed to quality improvement initiatives, and supervised medical students and junior residents.

Medical Resident

Arad County Clinical Hospital
Arad, Romania
11.2017 - 12.2019

As documented above

Education

M.D. - General Medicine

Vasile Goldis Western University
11.2017

Skills

  • Trial oversight and management (Start-up, maintenance, and close out)
  • Quality assurance (Data integrity, protocol/regulatory/GCP guideline adherence, CRFs, internal and external audit preparation)
  • Patient safety monitoring
  • Data management (Data entry and quality control, data cleanup, resolution of queries)
  • Source development and CTMS (Clinical Trial Maintenance Systems) maintenance
  • Regulatory compliance (TMF - Trial Master File)
  • Patient recruitment and retention
  • Patient safety monitoring
  • Informed consent processes
  • Internal auditing and external audit preparation
  • Creation and maintenance of trackers and spreadsheets
  • Interaction with CRA and monitors during onsite and remote visits
  • Query/findings resolution
  • Adverse event/deviation event reporting
  • CRF guidelines
  • Laboratory procedures (laboratory manuals, patient lab results, sample processing, and inventory maintenance)
  • Invasive and non-invasive medical procedures (surgical background, medical history, physical examinations, patient education, collection of vital signs, phlebotomy, EKGs/ECGs)

Certification

  • GCP Certification (Good Clinical Practice - U.S. FDA Focus)
  • CITI program Certifications (Biological Materials, OSHA Bloodborne Pathogens)
  • eSource Certification (CRIO)
  • Multiple CTMS Certifications (Rave, Veeva, etc)
  • EFS Certification
  • AAPC Medical Coding Course Certification (CPT and ICD-10)
  • ACLS Certification
  • CPR Certification
  • BLS/AED (Adult, child, infant)

Languages

  • English-Native, Bilingual
  • Romanian- Native, Bilingual

Languages

English
Native language
Romanian
Proficient (C2)
C2

Timeline

Senior Clinical Research Coordinator - DM Clinical Research
01.2022 - 03.2025
Medical Resident - University Emergency Hospital Bucharest - SUUB
01.2020 - 12.2020
Medical Resident - Arad County Clinical Hospital
11.2017 - 12.2019
Vasile Goldis Western University - M.D., General Medicine
Christina Muntean