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MARIA DE LA FUENSANTA ESCALANTE ESCALANTE

@mariadelafuensantaes

Clinical Research Coordinator at Specialized Clinical Research Center, managing regulatory submissions and clinical trial data in Medidata Rave.

Argentina
Message

At Specialized Clinical Research Center (MF Escalante), I prepare and follow up on regulatory submissions to ethics committees and authorities, and maintain the Investigator Site File in line with GCP requirements.

I report SAEs and SUSARs and coordinate protocol visits, sample processing, and participant support. I also enter clinical data and resolve queries in Medidata Rave, supporting interim monitoring visits and source data verification.

Previously, at Hospital Italiano de Córdoba, I coordinated Phase II–IV protocols and managed study supplies, investigational product traceability, and participant consent and retention. My experience also includes site start-up, regulatory documentation, and clinical trial coordination at LOA Clinical Research, Clínica de la Cañada, Instituto de Investigaciones Clínicas Córdoba, and Sanatorio León S. Morra.

Experience

Work history, roles, and key accomplishments

SE
Current

Assistant Clinical Research Coordinator & Regulatory Affairs

Specialized Clinical Research Center (MF Escalante)

Jan 2026 - Present (10 months)

Manages regulatory dossiers before Ethics Committees and authorities, maintains the Investigator Site File, reports SAEs/SUSARs, coordinates protocol visits, and handles data entry in EDC platforms.

Regulatory AffairsICH GCP
Investigational Site File (ISF)
SAE SUSAR Reporting
EDC
Medidata EDC
Protocol ManagementData Management
CC

Clinical Research Coordinator (CRC) / Data Entry & Regulatory

Clínica de la Cañada

Apr 2024 - Aug 2024 (4 months)

Performed administrative, logistical, and data management activities in multicenter clinical trials, and managed regulatory documentation before the Ethics Committee.

LR

Site Start-Up Specialist / Site Opening Coordinator

LOA Clinical Research

Feb 2024 - Aug 2024 (6 months)

Led site start-up and feasibility processes, designed and adapted operational areas, and coordinated investigator registration with COEIS.

Site Start Up
Feasibility
Regulatory Affairs
COEIS
Investigator Registration
Facility Design
Calibration Systems
IC

Clinical Research Coordinator (CRC)

Instituto de Investigaciones Clínicas Córdoba

Mar 2013 - Dec 2018 (5 years 9 months)

Supervised clinical trials ensuring adherence to ICH GCP, ANMAT regulations, and sponsor protocols.

Clinical ResearchICH GCP
ANMAT
Protocol Compliance
SM

Clinical Research Coordinator / Regulatory Assistant

Sanatorio León S. Morra

Jan 2008 - Oct 2013 (5 years 9 months)

Managed patient care, laboratory and medication logistics, and provided regulatory administrative support at the research site.

Patient Management
Laboratory Logistics
Pharmaceutical Logistics
Regulatory Support

Education

Degrees, certifications, and relevant coursework

SM

Sanatorio León S. Morra

Therapeutic Companion Training, Therapeutic Companion

2012 - 2013

Completed Therapeutic Companion Training at Sanatorio León S. Morra from 2012 to 2013.

National University of Córdoba logoNC

National University of Córdoba

English Teaching Degree, English Teaching

2008 - 2012

Earned an English Teaching Degree from the National University of Córdoba, completing tertiary education from 2008 to 2012.

Tech stack

Software and tools used professionally

Availability

Looking for a job

Location

Argentina

Authorized to work in

Salary expectations

60k+ USD

Skills

Clinical Research CoordinationClinical Trial ManagementICH GCP
Clinical Trial Regulatory Affairs
ANMAT
COEIS Regulations
Regulatory Submissions
Site Start Up
Site Feasibility
Ethics Submissions
Informed Consent FormsPharmacovigilance
SAE Reporting
SUSARs
Clinical Data Management

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