Call For The Recruitment Of A Coordinator/Manager Of Clinical Trials For The Foundation For La [...]

buscojobs España; Asturias; Presencial; EUR 25.000; Jornada completa

Descripción de la vacante

La Fundación para la Investigación Biomédica del Hospital Universitario Puerta de Hierro busca un coordinador de ensayos clínicos para un proyecto sobre una vacuna de influenza. El puesto requiere un título en enfermería y experiencia en ensayos clínicos. Se ofrece un contrato a tiempo completo con una dedicación de 37.5 horas a la semana y un salario de €24,038 anuales.

Formación

• Experiencia previa en la coordinación de ensayos clínicos con fármacos.
• Capacitación específica en Buenas Prácticas Clínicas.
• Nivel mínimo de inglés B2 o equivalente.

Responsabilidades

• Coordinar todos los documentos regulatorios para el proyecto de investigación.
• Asegurar la comunicación efectiva entre el equipo investigador.
• Mantener la documentación esencial del proyecto actualizada.

Conocimientos

Cumplimiento de Buenas Prácticas Clínicas

Comunicación efectiva

Colaboración

Educación

Grado en Enfermería

Descripción del empleo

Organisation / Company Instituto de Investigación Sanitaria Puerta de Hierro – Segovia de Arana (IDIPHISA) Research Field Medical sciences » Other Researcher Profile First Stage Researcher (R1) Positions Bachelor Positions Country Spain Application Deadline 3 Jul 2025 - 15 : 00 (Europe / Madrid) Type of Contract Temporary Job Status Full-time Hours Per Week 37.5 Offer Starting Date 19 Jun 2025 Is the job funded through the EU Research Framework Programme? Other EU programme Reference Number 2025-22 Is the Job related to staff position within a Research Infrastructure? No

Offer Description

The Foundation for Biomedical Research of the Puerta de Hierro University Hospital is the managing body of the Research Institute of the Puerta de Hierro University Hospital, IDIPHISA.

Being part of IDIPHISA means having the opportunity to develop biomedical research activities under conditions of quality and excellence, in the field of clinical and translational research, at national and international level. IDIPHISA currently has 5 research areas and 43 research groups.

JOB OFFER

The Fundación para la Investigación Biomédica del Hospital Universitario Puerta de Hierro announces a vacancy for a clinical trials coordinator / manager for the clinical trials / clinical pharmacology research area, with the category of professional group III, for the functional area 2 scientific-technical.

The clinical trials-clinical pharmacology research area is formed by 5 researchers and is mainly dedicated to the development of new drugs and has published 60 articles.

This contract is funded by the grant / project “A Phase 1 randomized, observer-blind, dose escalation study to evaluate the safety, reactogenicity and immunogenicity of an mRNAbased monovalent influenza vaccine candidate in healthy younger and older adults” (FLU SV MRNA-003),” funded by GSK with file number 83 / 22, whose objective is to evaluate the safety and reactogenicity of the seasonal influenza mRNA vaccine.

Being part of this project will provide experience in clinical research.

The activities to be developed are those established in the report of the mentioned project.

TASKS / FUNCTIONS TO BE PERFORMED :

o Coordinate all regulatory documents for the research project and ensure compliance with Good Clinical Practice standards, current applicable legislation and Standard Operating Procedures.

o Work with the project sponsor to ensure that the project is completed according to the established budget plan, timelines and commitments.

o Ensure effective communication between the investigator / promoter team and act as the primary contact for the promoter, if so designated.

o Coordinate, together with the Principal Investigator, the practical conduct of the study.

o Maintain essential project documentation up to date and properly archived in the project Master File.

o Perform compliance monitoring of the study procedures.

o Maintain updated information in the project management tools. o Actively collaborate in the study's practical development.

o Actively collaborate in the quality assurance of data, documentation and process.

o Preparation and conduct of study initiation, monitoring and closeout visits.

o Preparation of audits and inspections together with the principal investigator of the project.

o Pharmacovigilance support for the notification and follow-up of adverse events and reactions.

o and in general as many as necessary for the development of the project in accordance with the required nursing degree.

CANDIDATE REQUIREMENTS

• Nursing Degree
• Specific training in Good Clinical Practice standards
• Previous experience in the coordination of clinical trials with drugs.
• Minimum level of English B2 European level or equivalent.

Other merits to be valued :

• Knowledge in clinical research will be especially valued.
• Work experience in the health environment of more than 2 years will be a requirement.
• Academic training and professional experience abroad will be valued.

CONTRACT CONDITIONS

The type of contract is indefinite term scientific-technical.

The duration of the tasks to be performed is 3 years.

The duration of the contract is subject to :

a) The completion or termination of the project or phase / work package to which the contract is linked.

b) The completion or termination of the economic resources assigned to said project.

c) The termination or extinction of the specific line of financing assigned to the contracting of personnel within said project.

The salary is €24,038 gross per year, as established in the Collective Agreement of the Group of Companies of the Biomedical Research Foundations of the II.SS. of the Sermas.

The dedication will be 37.5 hours per week and it will not be possible to participate in another project.

The place of work is at the Hospital Universitario Puerta de Hierro de Majadahonda.

SUBMISSION OF APPLICATIONS

Those interested should send their Curriculum Vitae and the qualifications required in the call for applications by e-mail to the Fundación para la Investigación Biomédica del Hospital Universitario Puerta de Hierro Majadahonda at the following address : .

The subject of the e-mail should include the reference “Convocatoria de contratación Ref. 2025-22”.

Candidates must have the required qualifications on the date of publication of this call for applications.

Candidates with degrees obtained abroad must accredit the homologation of the degree or, if applicable, the corresponding certificate of equivalence issued by the competent body.

The deadline for submission of applications will be July 3, 2025, at 15 : 00 hours.

Submission of the application implies acceptance of the terms and conditions of the call for applications.

EVALUATION AND SELECTION PROCESS

Applications that meet the requirements and are within the deadline of the call will be examined by an evaluation committee composed of three members (a president and two members), who must have at least the same qualifications as those required in the call. One of the members may be replaced by HR personnel, if so considered by the PI.

Following the recommendation of the Equality Plan, the participation in the tribunals must be balanced between men and women, as far as possible, and its members will follow the recommendations and measures contained in said Plan to reduce the gender impact, having received the appropriate training for its application.

In accordance with the European Commission's OTMR code of conduct for the recruitment of researchers, the recruitment process follows the general principles and requirements in order to ensure respect for values, as well as transparency of the recruitment process and equal treatment of all applicants.

The Curriculum Vitae will be evaluated together with the merits indicated above. Only candidates who meet the minimum requirements established in the call for applications will be admitted for processing.

The selective system will consist of the following phases :

Phase A- Evaluation of Merits (maximum 60 points) :

The maximum score that may be awarded for the assessment of the different merits will be 60 points, which will be given by the sum of the score obtained in each of the sections :

• Training : Up to a maximum of 20 points
• Experience : Up to a maximum of 20 points
• Specific Requirements : Up to a maximum of 20 points.

The selection body may request from the interested parties any clarification it deems appropriate on the merits claimed.

The merits claimed must be possessed at the date of the deadline for submission of applications and must be duly documented in order to be assessed if deemed necessary.

In order to pass Phase A, and move on to Phase B interviews, it will be necessary to obtain an evaluation equal to or higher than 30 points.

Phase B of Aptitude Assessment and interview (maximum 40 points) : The interview will deal with any aspect related to the applicant's curriculum vitae and the position to be filled.

To pass phase B, it will be necessary to obtain an evaluation equal to or higher than 20 points.

Subjective parameters, such as a potentially valuable contribution to the candidate's professional development, especially in the case of researchers, towards a multidimensional career path, such as career breaks or chronological variations in the curriculum vitae, etc., must also be considered during the evaluation.

Once the deadline for the admission of applications has ended, the provisional list of applicants admitted in Phase A and who pass to Phase B of the interview will be made public by publishing the corresponding list on the FIBHUPH website : . Once the interviews have been carried out, the final decision of the selected candidate will be published in the same medium.

In the event that the candidate does not provide part of the required documentation, a period of 3 calendar days will be established for its correction, counting from the date of the request.

A period of 5 calendar days will be established for the presentation of allegations by the candidates. This period will not apply in the event that only one candidate applies.

The position may become vacant in the event that the candidates presented do not meet the requirements requested in this call.

If the selected candidate resigns before formalizing the contract, the PI may propose the next candidate on the list who meets the essential requirements and has obtained the score established in the call for applications.

In the case of incidents, the evaluation committee will submit to the Board of Trustees the results of the evaluation and the proposed resolution.

DATA PROTECTION

We inform you that your data will be processed, in accordance with the provisions of the Organic Law 3 / 2018 on the Protection of Personal Data and guarantee of digital rights and EU Regulation 679 / 2016, and will be incorporated into the processing system “RRHH- selección de personal”.

The person responsible for the processing of your data is the Foundation for Biomedical Research of the University Hospital Puerta de Hierro-Majadahonda, located at Calle Joaquín Rodrigo nº 2, Edifico Laboratorio, Ground Floor, 28222 Majadahonda-Madrid.

The purpose of the processing of your data is the management of personal data of candidates participating in the recruitment process. Your data will be kept while the selection process is being carried out and once it is finished, it will be securely deleted.

The legal basis that legitimizes the processing of your data lies in the consent that you have given at the time of joining the personnel selection process, in a free, unequivocal and specific manner. You will have the right to withdraw your consent at any time, in the same way you gave it, without affecting the lawfulness of processing prior to its withdrawal.

personal data and may exercise their rights of access, rectification or deletion, limitation of processing, opposition, portability, as well as not to be subject to decisions based solely on the automated processing of their data.

You may exercise your rights by sending an e-mail to or by writing to the following address : Joaquín Rodrigo nº 2, Edifico Laboratorio, Ground Floor, 28222 Majadahonda-Madrid.

MONITORING

The scientific follow-up will be carried out by means of the corresponding periodic and / or final reports to be submitted annually and at the end of the contract.

Candidates participating in this selection process accept all the terms of this call.

Where to apply

E-mail

Requirements

Research Field Medical sciences » Other Education Level Bachelor Degree or equivalent

Skills / Qualifications

TASKS / FUNCTIONS TO BE PERFORMED :

o Coordinate all regulatory documents for the research project and ensure compliance with Good Clinical Practice standards, current applicable legislation and Standard Operating Procedures.

o Work with the project sponsor to ensure that the project is completed according to the established budget plan, timelines and commitments.

o Ensure effective communication between the investigator / promoter team and act as the primary contact for the promoter, if so designated.

o Coordinate, together with the Principal Investigator, the practical conduct of the study.

o Maintain essential project documentation up to date and properly archived in the project Master File.

o Perform compliance monitoring of the study procedures.

o Maintain updated information in the project management tools. o Actively collaborate in the study's practical development.

o Actively collaborate in the quality assurance of data, documentation and process.

o Preparation and conduct of study initiation, monitoring and closeout visits.

o Preparation of audits and inspections together with the principal investigator of the project.

o Pharmacovigilance support for the notification and follow-up of adverse events and reactions.

o and in general as many as necessary for the development of the project in accordance with the required nursing degree.

Specific Requirements

CANDIDATE REQUIREMENTS

• Nursing Degree
• Specific training in Good Clinical Practice standards
• Previous experience in the coordination of clinical trials with drugs.
• Minimum level of English B2 European level or equivalent.

Other merits to be valued :

• Knowledge in clinical research will be especially valued.
• Work experience in the health environment of more than 2 years will be a requirement.
• Academic training and professional experience abroad will be valued.

The salary is €24,038 gross per year, as established in the Collective Agreement of the Group of Companies of the Biomedical Research Foundations of the II.SS. of the Sermas.

Selection process

CANDIDATE REQUIREMENTS

• Nursing Degree
• Specific training in Good Clinical Practice standards
• Previous experience in the coordination of clinical trials with drugs.
• Minimum level of English B2 European level or equivalent.

Other merits to be valued :

• Knowledge in clinical research will be especially valued.
• Work experience in the health environment of more than 2 years will be a requirement.
• Academic training and professional experience abroad will be valued.

Number of offers available 1 Company / Institute FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO PUERTA DE HIERRO Country Spain State / Province MAJADAHONDA City MADRID Postal Code 28222 Street Joaquin Rodrigo, 2 – Edificio Laboratorios – Planta Baja

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