Clinical Research Management Unit

The Clinical Research Management Unit plays an essential role in the proper conduct, oversight and regulatory compliance of clinical studies carried out within the Institute. Its activities focus on ensuring efficient, coordinated and regulation-compliant management, facilitating both the initiation and follow-up of research studies.

The Unit also ensures the effective operation of the Research Ethics Committee with Medicines (CEIm) by providing the administrative support required for the ethical review of research projects and acting as a liaison between investigators, sponsors and assessment bodies.

Through these activities, the unit contributes to ensuring the quality, safety and scientific rigor of clinical research, while promoting compliance with applicable regulations and the protection of study participants.

The Clinical Research Management unit is structured around three main areas of activity: Clinical research technical and administrative management, financial management of clinical research activities and Administrative Secretariat of the Research Ethics Committee with Medicines (CEIm).

Clinical Research Technical and Administrative Management

Functions

The main functions are:

• Administrative and operational management of clinical trials and observational studies.
• Ongoing coordination with investigators, sponsors and hospital departments involved in the studies.
• Preparation, review and submission of regulatory documentation required for study start-up.
• Feasibility assessment of study budgets, including evaluation of costs, resource requirements and overall study sustainability.
• Management, negotiation and review of clinical study agreements, ensuring their appropriate execution and formalisation.
• Comprehensive follow-up of ongoing studies, ensuring compliance with regulatory and administrative requirements.

Staff

Nieves Martínez García (nmartinez@iis-fjd.es; Ext 4492).

Cristina Blázquez Gómez (cristina.blazquezgom@iis-fjd.es; Ext 3194)

Ana Isabel Lopesino Badorrey (ana.lopesino@iis-fjd.es; Ext 3194)

María Florencia Spirito (florencia.spirito@iis-fjd.es; Ext 3194)

Clinical research financial management

This area plays an essential role in the financial management of activities related to clinical trials and other research projects. Its primary objective is to ensure accurate invoicing, income monitoring and efficient management of payments arising from research activities, while guaranteeing compliance with the contractual agreements established with sponsors and funding organisations.

Functions

The main functions are:

• Issuance and management of invoices related to clinical research activities in accordance with the terms established in the corresponding agreements and contracts.
• Verification of billable milestones and activities in accordance with the contractual arrangements agreed with study sponsors.
• Administrative registration and control of invoicing processes.
• Coordination with the financial management unit to ensure appropriate accounting integration and financial oversight.
• Monitoring and control of income generated through clinical trials and other research activities.
• Management of payments received, reconciliation of accounts, and resolution of financial discrepancies or issues.
• Coordination with sponsors and internal departments to ensure the timely and accurate receipt of research-related income.

Staff

Gema Navarrete Segade (gnavarrete@quironsalud.es; Ext 4707)

Sheila Belinchon Fernández: sheila.belinchon@iis-fjd.es; Ext 4707). (Until 01/10/2025)

Narcisa de Jesús Crofford Torres narcisa.crofford@iis-fjd.es; Ext 4707)

Carlos García González: carlos.garciagonza@iis-fjd.es; Ext 4708). (Until 22/09/2025)

David Martínez Cuenca: david.mcuenca@iis-fjd.es; Ext 4708)

Leonor Ramos Terreros: leonor.ramos@iis-fjd.es; Ext 4708)

José Carlos Sánchez Rodríguez: JCSanchezR@fjd.es; Ext 4708)

Administrative Secretariat of the CEIm

Functions

The main functions are:

• Administrative management of the Research Ethics Committee with Medicines (CEIm).
• Receipt, validation and processing of the documentation required for the ethical review of research studies.
• Organisation of CEIm meetings, including the preparation of meeting agendas, minutes and associated reports.
• Communication with investigators and sponsors regarding committee decisions, requests for additional information, and the follow-up of ethical aspects related to research studies.

Staff

Nieves Martínez García (nmartinez@iis-fjd.es; Ext 4492).

Tamara Oria Valero (tamara.oria@iis-fjd.es; Ext 4492)

Noemi Rodríguez Beas: (noemi.rodriguezbeas@iis-fjd.es; Ext 4492)

Contact: ceic@fjd.es; Ext 4492