Clinical Research Associate II

hace 1 día

Barcelona, Barcelona, España Fortrea A tiempo completo

Summary Of Responsibilities

  • Site management for clinical studies is conducted in accordance with Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans, and sponsor requirements. This includes verifying that study training records are complete and accurate.
  • Site monitoring responsibilities cover all phases of a clinical trial—Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits—ensuring compliance with regulatory and protocol standards.
  • Project plans related to clinical monitoring are prepared and implemented to align with study timelines and deliverables.
  • Subject protection is ensured through eligibility reviews and verification that informed consent procedures and protocol requirements are followed in accordance with regulatory expectations.
  • Data integrity is safeguarded through thorough source document review, source data verification, query generation and resolution, all performed using Fortrea or sponsor data management systems.
  • Site regulatory documentation and eTMF/Sponsor files are maintained to be complete and current throughout the trial duration, ensuring audit readiness.
  • Investigational Product inventory and accountability are confirmed to be accurate, with secure storage and handling per protocol. Additional responsibilities include supporting CRA performance metrics, acting as Lead CRA when assigned, and collaborating with study teams to meet project goals.

Qualifications (Minimum Required)

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
  • Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
  • Thorough knowledge of monitoring procedures.
  • Fluent in local office language and in English, both written and verbal.

Experience (Minimum Required)

  • MANDATORY experience of minimum 1 year already as independent CRA with Spanish sites.
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
  • Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.
  • Therapeutic area' expertise required: expertise in oncology and hematology, and expertise in CAR-T is a plus.

Preferred Qualifications Include

  • Good understanding of the principles of ICH GCP, ISO if applicable) and local regulatory requirements.
  • Good analytical and negotiation skills.
  • Experience using e-clinical systems [e.g., clinical trial management system (CTMS)].

Physical Demands/Work Environment

  • Will involve outside of normal office hours as required by the role.
  • Travel Requirement is 60% of the time (traveling to study sites).

Learn more about our EEO & Accommodations request here.

  • Clinical Research Associate 1

    hace 2 semanas

    Barcelona, Barcelona, España IQVIA A tiempo completo

    Clinical Research Associate Your responsibilities will include:Performing site selection, initiation, monitoring and close-out visits after completing training periodSupporting the development of a subject recruitment planEvaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and...

  • Clinical Research Associate II

    hace 3 días

    Barcelona, Barcelona, España Fortrea A tiempo completo

    Summary of Responsibilities:Site management for clinical studies is conducted in accordance with Fortrea's Standard Operating Procedures, ICH GCP Guidelines, applicable project plans, and sponsor requirements. This includes verifying that study training records are complete and accurate.Site monitoring responsibilities cover all phases of a clinical...

  • Clinical Research Associate 2

    hace 5 días

    Barcelona, Barcelona, España IQVIA A tiempo completo

    Clinical Research AssociateIQVIA Spain is looking for talented and motivated team member to join our Sponsor dedicated team as junior CRA. At this position you will have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas, and build a meaningful, strong career within our...

  • Clinical Research

    hace 2 semanas

    Barcelona, Barcelona, España Vall d'Hebron Institute of Research (VHIR) - Vall d'Hebron Institut de Recerca A tiempo completo

    VHIR offers 2 vacancies position for a Clinical researcher specializing in endocrinology within the Diabetes and Metabolism Research Group.Education and qualifications:Required:Medical Specialist in Endocrinology and NutritionFluency in Catalan, Spanish, English (business level)Experience and knowledge:Required:Experience in Clinical Research.Experience in...

  • Clinical Research Associate

    hace 2 semanas

    Barcelona, Barcelona, España TFS HealthScience A tiempo completo

    CRA Barcelona - Single sponsor - Recognized Biotech CompanyAbout this roleTFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service...

  • PCOR Research Associate

    hace 2 semanas

    Barcelona, Barcelona, España Bayer Crop Science A tiempo completo

    PCOR Research Associate Purpose:The Patient-Centered Outcomes Research Associate (RA) plays a crucial role in supporting scientific coordination and project management related to clinical outcome assessments (COAs, including patient- reported outcomes, PROs) within and beyond the scope of clinical trials. The role involves close collaboration within the...

  • Clinical Site Manager II

    hace 2 semanas

    Barcelona, Barcelona, España ICON plc A tiempo completo

    Clinical Site Manager / Senior CRA Home based SpainICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Senior Clinical Research...

  • Clinical Site Manager II

    hace 2 semanas

    Barcelona, Barcelona, España ICON plc A tiempo completo

    Clinical Site Manager / Senior CRA Home based SpainICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Senior Clinical Research...

  • Clinical Research

    hace 2 semanas

    Barcelona, Barcelona, España Vall d'Hebron Institut de Recerca A tiempo completo

    VHIR offers 2 vacancies position for a Clinical researcher specializing in endocrinology within the Diabetes and Metabolism Research Group.Education and qualifications:Required:Medical Specialist in Endocrinology and NutritionFluency in Catalan, Spanish, English (business level)Experience and knowledge:Required:Experience in Clinical Research.Experience in...

  • Clinical Research Associate Junior

    hace 1 día

    Barcelona, Barcelona, España K ACCESS HEALTH PROJECTS A tiempo completo

    Sobre K ACCESS HEALTH PROJECTSK ACCESS HEALTH PROJECTS es una empresa enfocada en la gestión y monitorización deestudios clínicos y proyectos de investigación en salud, ofreciendo soluciones de alta calidad para promover innovación clínica y garantizar la excelencia operativa en ensayos clínicos en fase de crecimiento. Nos enorgullece trabajar con...