PhD in Research

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PhD in Research

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Job description

Offer DescriptionFirst.- Start the selection process for the recruitment of 1 PhD in Research, in accordancewiththecriteria,requirements, and selection system that is set in the document hereto annexed.RequirementsResearch Field Biological sciences » Other Education Level PhD or equivalentSkills/QualificationsThe tasks to be performed include, among others:As project manager:– Project planning– Communication with regulatory bodies (AEMPS, CEIm…)– Resource management– Coordination of monitoring teams– Risk management and contingency plans– Ensuring regulatory and ethical compliance of the projects.– Ensuring the development of the project within the required quality standards.As a clinical trial monitor:– Conducting screening visits, initiation, monitoring and closure of research sites in accordance with the approved protocol.– Maintaining study files (ISF, pharmacy file)– Communicating with site staff, including coordinators, clinical research physicians and pharmacists– Verification of appropriate investigator qualifications, training and resources; verification of the suitability of facilities, laboratories, equipment and personnel for the conduct of the study.Verification of documentation of medical records and source documents against data collection notebooks, ensuring that good documentation practices are adhered to and reporting protocol deviations appropriately according to SOPs, GCP and applicable regulatory requirements;– Verification of patient selection criteria.– Review of regulatory documentation– Accounting and inventory of medical devices and/or investigational products/pharmaceuticals.– Verification and review of adverse events, serious adverse events, concomitant medications and corresponding diseases to confirm accurate reporting of data in accordance with the protocol.Evaluate the success of the clinical research site’s patient recruitment and retention and offer suggestions for improvement;– Conducting monitoring reports and follow-up letters, including summaries of significant findings, deviations, deficiencies and recommended actions to ensure accurate data compliance in accordance with the protocol.Specific Requirements1.Be a Spanish national, a national of a member country of the European Union or a foreigner with a residence and work permit in Spain.2. To Have a Doctorate Degree in Health Sciences.The minimum requirements must be accredited with those certificates that are valid in law, including all those that demonstrate the aforementioned professional experience, in line with the functions to be performed and the assessment criteria.In the case of qualifications obtained abroad, their homologation must necessarily be accredited.The conclusion of the contract is subject to the availability of the project’s budget and to the successful candidate’s compliance with the requirements of current employment legislation. In case of non-compliance with the requirements, the next candidate will be contacted in order of score.Languages ENGLISH Level GoodLanguages SPANISH Level Mother TongueResearch Field Biological sciences » Biology Years of Research Experience 1 – 4Additional InformationBenefitsType of contract:Indefinite-term contract (art 23. Bis of Law 14/2011 LCTI).Full time: 35 hours.– Financial remuneration:2,728.16 euros gross per month including the proportional part of two extraordinary payments.– Research project:ICI23/00027 – Allogeneic mesenchymal cells (MSC) in ocular injection as a therapy for graft-versus-recipient disease (GVHD) refractory to conventional treatments.– Work centre:Complejo Asistencial Universitario de Salamanca.Eligibility criteria1. Valoración curricular de méritos y capacidades (0-30 puntos)a) Experiencia demostrable como Gestor de Estudios de investigación clínicos, especialmente académicos (0-8 puntos).b) Experiencia demostrable en la monitorización de ensayos clínicos, especialmente académicos (0-8 puntos).c) Máster en investigación clínica (0-4 puntos).d) Certificado de Buenas Prácticas Clínicas (BPC) (0-2 puntos).e) Conocimientos sólidos de farmacovigilancia (0-2 puntos).f) Formación específica en productos sanitarios (0-2 puntos).g) Nivel intermedio-avanzado de inglés (0-2 puntos)h) Certificado de discapacidad (0-2 puntos)2. Entrevista personal: (0-20 puntos).Se valorará la disponibilidad para viajar.Se valorarán las siguientes competencias:− Buenas aptitudes de comunicación y expresión escrita− Fuerte pensamiento crítico, analítico y motivador.− Persona orientada a objetivos.− Capacidad de autogestión y de gestión de equipos.− Actitud proactiva y positiva.− Comprender la finalidad de la monitorización (asegurar la seguridad del paciente y la integridad de los datos; supervisión del investigador principal; cumplimiento de las BPC/ICH y del protocolo).− Capacidad para desarrollar numerosas tareas simultáneamente.− Capacidad de trabajo en equipo.− Alto grado de flexibilidad para adaptarse a condiciones cambiantes.Selection processThe selection process is governed by the principles of publicity, equality, merit, andability,constitutingtheeffect one selecting body composed of representatives of the group of research and oftheTechnical Unitofmanagement of IBSAL.The selection process will consist of two phases:1. Analysis phase and curricular value of all nominations received, classified on the basis ofbetteradaptationof the Curriculum Vitae to the profile established and compliance with the requirements.2. Personal interview: the three candidates with the highest marks in Phase 1 will be invitedtoapply,providedthat their marks in Phase 1 exceed one half plus one. The Selection Board may proposethatthecall forapplications be declared void if no candidate is suitable for the post.Additional commentsPublication of the resolution on the admission of applications with the list of persons admittedandnotadmittedaccording to minimum requirements and granting of a period of 5 calendar days forthepresentationofallegations.Publication of the resolution with the detailed provisional ranking and granting of a period of 5calendardaysforthe presentation of allegations.Publication of the final resolution with the final ranking and the Act of awarding of theplacewithinfifteenworking days from the deadline for submission of applications.*The publication will have the effect of notification, this publication will replace the individualnotificationtotheinterested parties and will have the same effects. Website for additional job detailsWork Location(s)Number of offers available 1 Company/Institute Instituto de Investigación Biomédica de Salamanca (IBSAL) Country Spain State/Province Salamanca City Salamanca Postal Code 37007 Street Paseo de San Vicente 58-182Where to apply WebsiteContact State/ProvinceSalamanca CitySalamanca WebsiteStreetPaseo de San Vicente 58-182 Postal Code37007 E-Mail[email protected]STATUS: EXPIRED

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Location

Salamanca

Job date

Fri, 31 May 2024 22:59:02 GMT

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