Cra Ii Madrid. Sponsor Dedicated

hace 1 semana

Fuenlabrada, Madrid, España Grabjobs Spain A tiempo completo
Clinical Research Associate II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do.

We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with.

Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Job responsibilities

  • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
  • Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
o Assesses site processes
o Conducts Source Document Review of appropriate site source documents and medical records
o Verifies required clinical data entered in the case report form (CRF) is accurate and complete
o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
o Verifies site compliance with electronic data capture requirements

  • May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
  • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.
  • May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
  • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
  • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
  • For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II

Additional responsibilities include:
o Site support throughout the study lifecycle from site identification through close-out
o Knowledge of local requirements for real world late phase study designs
o Chart abstraction activities and data collection
o Collaboration with Sponsor affiliates, medical science liaisons and local country staff
o The SMA II may be requested to train junior staff
o Identify and communicate out of scope activities to Lead CRA/Project Manager
o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
Qualifications What we're looking for

  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills
  • Ability to manage required travel of up to 75% on a regular basis

Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Learn more about Syneos Health .

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.

Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

  • Expendedor/a Gasolinera Vacaciones/incremento de

    hace 2 semanas

    Fuenlabrada, Madrid, España PLENOIL A tiempo completo

    Descripción:¿Tienes experiência en puestos de Atención al Cliente? ¿Te gustaría formar parte de un proyecto en plena expansión? Si es así, esto te interesaDesde Plenoil, empresa líder en venta de combustible, estamos buscando perfiles de expendedores para nuestra Estación de Servicio ubicada en FUENLABRADA Y LEGANES para cubrir ausencias por...

  • Expendedor/A Gasolinera Vacaciones/Incremento De

    hace 2 semanas

    Fuenlabrada, Madrid, España Plenoil A tiempo completo

    Descripción:¿Tienes experiência en puestos de Atención al Cliente? ¿Te gustaría formar parte de un proyecto en plena expansión? Si es así, esto te interesaDesde Plenoil, empresa líder en venta de combustible, estamos buscando perfiles de expendedores para nuestra Estación de Servicio ubicada en FUENLABRADA Y LEGANES para cubrir ausencias por...

  • Mecánico electrónico

    hace 1 mes

    Fuenlabrada, Madrid, España Madrileña de Mantenimiento CAR S.L. A tiempo completo

    Somos MADRILEÑA DE MANTENIMIENTO CAR S.L., una empresa modesta, prospera y en constante crecimiento, especializada en la venta y asistencia técnica de carretillas elevadoras y todo tipo de máquinas de interior. Desde nuestra creación en 1995 buscamos la excelencia, implementando los avances técnicos más punteros en el sector y garantizando el mejor...

  • Mecánico electrónico

    hace 4 semanas

    Fuenlabrada, Madrid, España Madrileña de Mantenimiento CAR S.L. A tiempo completo

    Somos MADRILEÑA DE MANTENIMIENTO CAR S.L., una empresa modesta, prospera y en constante crecimiento, especializada en la venta y asistencia técnica de carretillas elevadoras y todo tipo de máquinas de interior. Desde nuestra creación en 1995 buscamos la excelencia, implementando los avances técnicos más punteros en el sector y garantizando el mejor...

  • Expendedor/a Gasolinera Fin de Semana Fuenlabrada

    hace 2 semanas

    Fuenlabrada, Madrid, España PLENOIL A tiempo completo

    Descripción:¿Tienes experiência en puestos de atención al cliente? ¿Te gustaría encontrar un puesto de FINES DE SEMANA? Si buscas un empleo para compaginar con estudios u otras actividades, esto te interesaDesde Plenoil, empresa líder en el sector de los hidrocarburos, estamos buscando un perfil de expendedor/a a jornada parcial con 20 horas semanales...

  • Mecánico /a Itinerante - Madrid

    hace 2 semanas

    Fuenlabrada, Madrid, España Tesla A tiempo completo

    Tesla participates in the E-Verify ProgramWhat to Expect¿Quieres ayudar a acelerar la transición del mundo hacia la energía sostenible?En Tesla, esta es nuestra misión.En Tesla, nuestros/as Mecánicos/as son la espina dorsal de nuestras operaciones de servicio, apoyando nuestra misión de acelerar la transición del mundo hacia la energía sostenible....

  • Principal Clinical Trial Manager

    hace 2 semanas

    Fuenlabrada, Madrid, España Grabjobs Spain A tiempo completo

    Principal Clinical Trial Manager - Oncology or Ophtlamology experience required Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model...

  • Mecánico /a - Service Technician , Madrid

    hace 2 semanas

    Fuenlabrada, Madrid, España Tesla A tiempo completo

    What to Expect En Tesla, nuestros/ as Técnicos son la espina dorsal de nuestras operaciones de servicio, apoyando nuestra misión de acelerar la transición del mundo hacia la energía sostenible. Hemos creado la flota de vehículos más innovativa de la historia, y tú, como Técnico Service, ayudarás a prestar un servicio igualmente innovativo a...

  • Cra Ii Madrid. Sponsor Dedicated.

    hace 4 semanas

    Fuenlabrada, España Grabjobs Spain A tiempo completo

    Clinical Research Associate II Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  Our Clinical Development model brings the customer and the patient to the center...

  • Cra Ii Madrid. Sponsor Dedicated.

    hace 4 semanas

    Fuenlabrada, España Grabjobs Spain A tiempo completo

    Clinical Research Associate II Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  Our Clinical Development model brings the customer and the patient to the center...

  • Expendedor/a Gasolinera Vacaciones/incremento de

    hace 3 semanas

    Fuenlabrada, España PLENOIL A tiempo completo

    **Descripción**: ¿Tienes experiência en puestos de Atención al Cliente? ¿Te gustaría formar parte de un proyecto en plena expansión? Si es así, ¡esto te interesa! Desde Plenoil, empresa líder en venta de combustible, estamos buscando perfiles de expendedores para nuestra Estación de Servicio ubicada en FUENLABRADA Y LEGANES** **para cubrir...

  • Expendedor/A Gasolinera Vacaciones/Incremento De

    hace 4 semanas

    Fuenlabrada, España Plenoil A tiempo completo

    **Descripción**:¿Tienes experiência en puestos de Atención al Cliente? ¿Te gustaría formar parte de un proyecto en plena expansión? Si es así, ¡esto te interesa!Desde Plenoil, empresa líder en venta de combustible, estamos buscando perfiles de expendedores para nuestra Estación de Servicio ubicada en FUENLABRADA Y LEGANES** **para cubrir ausencias...

  • Expendedor/A Gasolinera Vacaciones/Incremento De

    hace 1 mes

    Fuenlabrada, España Plenoil A tiempo completo

    **Descripción**:¿Tienes experiência en puestos de Atención al Cliente? ¿Te gustaría formar parte de un proyecto en plena expansión? Si es así, ¡esto te interesa!Desde Plenoil, empresa líder en venta de combustible, estamos buscando perfiles de expendedores para nuestra Estación de Servicio ubicada en FUENLABRADA Y LEGANES** **para cubrir ausencias...

  • Expendedor/A Gasolinera Vacaciones/Incremento De Actividad. Fuenlabrada

    hace 2 meses

    Fuenlabrada, España Plenoil A tiempo completo

    Descripción¿Tienes experiencia en puestos de Atención al Cliente? ¿Te gustaría formar parte de un proyecto en plena expansión? Si es así, ¡esto te interesa!Desde Plenoil, empresa líder en venta de combustible, estamos buscando perfiles de expendedores para nuestra Estación de Servicio ubicada en FUENLABRADA Y LEGANESpara cubrir ausencias por...

  • Mecánico electrónico

    hace 4 semanas

    Fuenlabrada, España Madrileña de Mantenimiento CAR S.L. A tiempo completo

    Somos MADRILEÑA DE MANTENIMIENTO CAR S.L., una empresa modesta, prospera y en constante crecimiento, especializada en la venta y asistencia técnica de carretillas elevadoras y todo tipo de máquinas de interior. Desde nuestra creación en 1995 buscamos la excelencia, implementando los avances técnicos más punteros en el sector y garantizando el mejor...

  • Mecánico electrónico

    hace 1 mes

    Fuenlabrada, España Madrileña de Mantenimiento CAR S.L. A tiempo completo

    Somos MADRILEÑA DE MANTENIMIENTO CAR S.L., una empresa modesta, prospera y en constante crecimiento, especializada en la venta y asistencia técnica de carretillas elevadoras y todo tipo de máquinas de interior. Desde nuestra creación en 1995 buscamos la excelencia, implementando los avances técnicos más punteros en el sector y garantizando el mejor...

  • Mecánico /a Itinerante - Madrid

    hace 3 semanas

    Fuenlabrada, España Tesla A tiempo completo

    Tesla participates in the E-Verify Program What to Expect - ¿Quieres ayudar a acelerar la transición del mundo hacia la energía sostenible? En Tesla, esta es nuestra misión. En Tesla, nuestros/as Mecánicos/as son la espina dorsal de nuestras operaciones de servicio, apoyando nuestra misión de acelerar la transición del mundo hacia la energía...

  • Mecánico /a - Service Technician , Madrid

    hace 5 días

    Fuenlabrada, España Tesla A tiempo completo

    What to Expect - En Tesla, nuestros/ as Técnicos son la espina dorsal de nuestras operaciones de servicio, apoyando nuestra misión de acelerar la transición del mundo hacia la energía sostenible. Hemos creado la flota de vehículos más innovativa de la historia, y tú, como Técnico Service, ayudarás a prestar un servicio igualmente innovativo a...

  • Field Service Engineer Madrid

    hace 5 días

    Fuenlabrada, España Beckman Coulter Life Sciences A tiempo completo

    .Wondering what's within Beckman Coulter Life Sciences (LS)? Take a closer look. At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates...

  • Technical Customer Support Madrid

    hace 5 días

    Fuenlabrada, España Beckman Coulter Diagnostics A tiempo completo

    At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward.Join a team where you can be heard, be supported, and always be yourself.We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates.Look again and you'll...