Clinical Research Associate
hace 5 meses
**Summary**:
Supervisa los datos de los pacientes y la información relacionada con el estudio relacionada con los sitios de estudio clínico y la participación en los ensayos clínicos. Garantiza que el investigador se adhiere a los protocolos de investigación, los requisitos reglamentarios y las buenas prácticas clínicas y proporciona información sobre el plan de validación de datos. Proporciona un monitoreo oportuno y preciso de los datos del paciente y la información relacionada con el estudio de los documentos de origen, los registros de investigación y las visitas al sitio cuando corresponda. Pueden monitorear los sitios de estudio y la selección de instalaciones de auditoría.
**About the Role**:
**Location: Sevilla, Spain, Hybrid Working, #LI-Hybrid**
This is a site relationship management role to ensure sustainable trial execution at Site. Performs on-site and remote monitoring activities related to initiation, conduct and timely completion of Phase I-IV Global Drug Development (GDD) trials within the country in adherence with monitoring procedures and processes in accordance with International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) / Good Clinical Practice (GCP), local regulations and Standard Operating Procedures (SOPs). Proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites. (From issue management to risk identification).
**Key Responsibilities**:
Your responsibilities include but are not limited to:
- Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
- Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
- Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
- Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol ICH / GCP, global and local regulation including Health Authorities, Institutional Review Board (IRB) / Ethics Committee (EC), data privacy requirements, global and local processes as applicable. Documentation according to Good Development Practice (GDP) and Novartis standards.
- Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow-up activity and archiving requirements.
- Proactively collaborates with the Site & Study Operations (SSO) Clinical Project Managers (CPM) and CRA Managers as well as Medical Science Liaisons, Clinical Research Medical Advisors (CRMA) and medical advisors to ensure optimal recruitment, site development and data quality.
- Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
**Key Performance Indicators (KPIs)**
- Next level of site collaboration measured by patient density at site, achievements of commitments and targets and deliver customer satisfaction results.
- Ensures the delivery of high-quality data according to agreed timelines with adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements.
- Quality and timeliness of updating the Novartis systems, monitoring reports, and communication efforts as defined by global KPIs and key quality indicators (KQIs)
**Essential Requirements**:
- Degree in scientific or healthcare discipline
- Fluent in both written and spoken English and Spanish
- 2 years pharmaceutical industry experience or other relevant experience
- Central/in-house monitoring or field monitoring experience
- Knowledge of international standards (GCP/ICH, Food & Drug Administration (FDA), European Medicines Agency (EMA)
- Understanding the purpose of the CRA (Patient Safety; Data Integrity; Principal Investigator (PI) Oversight; GCP/ICH & Protocol Compliance)
**Why Novartis?**
- **You’ll receive**:
- **Commitment to Diversity and Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
- **Join our Novartis Network**:
**Key Responsibilities**:
Your responsibilities include but are not limited to:
- Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset.
- Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
- Performs Site Initiation Visit, ensures site personnel is fully trained on all trial re
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