# MARIA DE LA FUENSANTA ESCALANTE ESCALANTE

MARIA DE LA FUENSANTA ESCALANTE ESCALANTE is a remote worker on Himalayas, Assistant Clinical Research Coordinator & Regulatory Affairs at Specialized Clinical Research Center (MF Escalante), based in Argentina.

Source: https://himalayas.app/@mariadelafuensantaes

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

| Detail | Value |
| --- | --- |
| Availability | Looking for a job |
| Location | Argentina |
| Authorized to work in | Argentina |
| Salary expectations | 60k+ USD |
| Job categories | Clinical Research Coordinator, Regulatory Affairs Specialist, Data Manager, Site Start Up Specialist |
| Skills | Clinical Research Coordination, Clinical Trial Management, ICH GCP, Clinical Trial Regulatory Affairs, ANMAT, COEIS Regulations, Regulatory Submissions, Site Start Up, Site Feasibility, Ethics Submissions, Informed Consent Forms, Pharmacovigilance, SAE Reporting, SUSARs, Clinical Data Management |

## About

```text
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

### Assistant Clinical Research Coordinator & Regulatory Affairs (current)

Specialized Clinical Research Center (MF Escalante). Jan 2026 - Present

```text
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.
```

Skills: Regulatory-Affairs, ICH-GCP, Investigational-Site-File-(ISF), SAE-SUSAR-Reporting, EDC, Medidata-EDC, Protocol-Management, Data-Management

### Clinical Research Coordinator (CRC) / Data Entry & Regulatory

Clínica de la Cañada. Apr 2024 - Aug 2024

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

Skills: Clinical-Research, Data-Management, Regulatory-Documentation, Ethics-Committees, Multi-Center-Trials

### Site Start-Up Specialist / Site Opening Coordinator

LOA Clinical Research. Feb 2024 - Aug 2024

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

Skills: Site-Start-Up, Feasibility, Regulatory-Affairs, COEIS, Investigator-Registration, Facility-Design, Calibration-Systems

### Clinical Research Coordinator (CRC) & Regulatory Specialist

Hospital Italiano de Córdoba. Jan 2020 - Aug 2024

```text
Coordinated clinical research protocols in Phases II-IV, managed study supplies and investigational product logistics, and supported participant recruitment and data entry.
```

Skills: Clinical-Research, ICH-GCP, Protocol-Compliance, IP-Accountability, Cold-Chain-Management, Participant-Recruitment, Informed-Consent-Forms, E-CRF, Data-Entry

### Clinical Research Coordinator (CRC)

Instituto de Investigaciones Clínicas Córdoba. Mar 2013 - Dec 2018

```text
Supervised clinical trials ensuring adherence to ICH GCP, ANMAT regulations, and sponsor protocols.
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Skills: Clinical-Research, ICH-GCP, ANMAT, Protocol-Compliance

### Clinical Research Coordinator / Regulatory Assistant

Sanatorio León S. Morra. Jan 2008 - Oct 2013

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

Skills: Patient-Management, Laboratory-Logistics, Pharmaceutical-Logistics, Regulatory-Support

## Education

### Sanatorio León S. Morra

Therapeutic Companion Training, Therapeutic Companion. 2012 - 2013

```text
Completed Therapeutic Companion Training at Sanatorio León S. Morra from 2012 to 2013.
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### National University of Córdoba

English Teaching Degree, English Teaching. 2008 - 2012

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

- Microsoft Excel

To contact MARIA DE LA FUENSANTA, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire).

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