Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic
Florencia Ianco

Florencia Ianco

Clinical Research Specialist (Site Management/Engagement)
CABA

Summary

Highly motivated and detail-oriented Clinical Research Professional with nearly 16 years of comprehensive experience (since 2009) as a Study Coordinator, specializing in the comprehensive management of clinical studies from startup to closeout. Proven ability to optimize study start-up processes, manage complex site activation logistics, ensure rigorous regulatory compliance (GCP R3, ANMAT 6677/2010), and oversee study conduct for Phase II-III-IV trials. Expert in navigating intricate regulatory submissions (IRB/IEC, Health Authorities, ANMAT) and effectively coordinating site teams. Seeking to transition to Site Management or Site Engagement roles, leveraging up-to-date knowledge in GCP, ANMAI regulations, and the ethical principles of the WMA Declaration of Helsinki (2024 revision) to drive efficiency and contribute to impactful research within a growth-oriented organization.

Overview

17
17
years of professional experience
2001
2001
years of post-secondary education
3
3
Certifications
2
2
Languages

Work History

Sr. Clinical Research Coordinator

CARE - Centro de Alergia y Enfermedades Respiratorias
10.2012 - Current
  • - Led the comprehensive management of multiple simultaneous clinical studies across various therapeutic areas, ensuring adherence to research protocols, Good Clinical Practice (GCP), and local regulations (ANMAT).
  • - Expertly managed essential regulatory documentation (e.g., 1572 forms, investigator CVs, ethics committees approvals, amendments), maintaining complete and up-to-date study files for audits and inspections.
  • - Served as the primary point of contact between site investigators, sponsors, CROs, and ethics committees, facilitating smooth communication and proactively resolving operational and regulatory challenges.
  • - Coordinated sponsor monitoring visits, ensuring documentation and site personnel availability, and effectively addressing findings to maintain study data quality and integrity.
  • - Provided ongoing training to site staff on study protocols, Standard Operating Procedures (SOPs), and regulatory and ethical requirements, including the principles of the Declaration of Helsinki.
  • - Actively participated in the startup process for new studies, including site feasibility assessment, and preparation for initiation visits. Implemented strategies for patient retention and ensured the collection of high-quality data within established timelines.

Site Consultant

Independent
01.2018 - 01.2020
  • Managed site relationship teams, ensuring effective communication and collaboration between study sites and sponsors.
  • Collaborated with study start-up teams to ensure the achievement of timelines for site activation and study initiation.

Study Coordinator

IME - Instituto de Medicina Experimental
01.2009 - 01.2012
  • - Coordinated clinical studies, managing regulatory documentation and ensuring compliance with research protocols and ethical guidelines.
  • - Assisted in the communication between investigators, sponsors, and ethics committees.

Education

Attorney -

Universidad De Buenos Aires
09-2001

Clinical Research Training

Skills

Technical Skills — Clinical Study Management (Startup to Closeout) Regulatory Documentation Management CRF/EDC/CTMS Systems Adjudication Data Collection and Quality Control Patient Retention Strategies Monitoring Visit Coordination Site Feasibility Assessment Relationship Management Knowledge of healthcare, clinical trials & regulations Project Management

Certification

Good Clinical Practice (GCP) R3 - July 2025

Timeline

Site Consultant

Independent
01.2018 - 01.2020

Sr. Clinical Research Coordinator

CARE - Centro de Alergia y Enfermedades Respiratorias
10.2012 - Current

Study Coordinator

IME - Instituto de Medicina Experimental
01.2009 - 01.2012

Attorney -

Universidad De Buenos Aires

Clinical Research Training

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Florencia IancoClinical Research Specialist (Site Management/Engagement)