Site Monitor with Portuguese
hace 5 días
Spain, Remote
**Job ID** R0000019935
**Category** Clinical Trials
**ABOUT THIS ROLE**:
**Key Accountabilities**
- Ensuring regulatory, ICH-GCP 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 significant 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 Standard Operating Procedures (SOPs)/processes
- Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations
- Conducts source document review and verification of appropriate site source documents and medical records
- Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete
- Manages reporting of protocol deviations and appropriate follow up
- Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP
- Conducts follow up for escalated adverse event monitoring (AEM) report queries
- Collaborates with primary Site Manager who will act as the primary liaison with site personnel
**The Individual**
- A minimum of 1 year experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite)
- Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience
- Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice
- Proficiency in local language is required
- ** English proficiency is required plus fluent Spanish and Portuguese**
- Ability to manage required travel of on a regular basis
**Skills**
- Networking and relationship building skills
- Ability to communicate effectively and appropriately with internal and external stakeholders
- Ability to adapt to changing technologies and processes
- Effectively overcoming barriers encountered during the implementation of new processes and systems
- Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization
- Identifies and builds effective relationships with investigator site staff and other stakeholders
- Must demonstrate good computer skills and be able to embrace new technologies
LI-REMOTE
-
Data Centre Site Development Portfolio Manager
hace 2 días
En remoto, España Meta A tiempo completoMeta designs, builds, leases and operates the most innovative and efficient data centres in the world. Locating, developing and managing this data centre infrastructure the "right" way is synonymous with ensuring high uptime, capacity availability, flexibility and capital and operational cost efficiency. We are seeking an experienced and organised program...
-
Site Reliability Engineer
hace 7 días
En remoto, España Novatec Software Engineering España SL A tiempo completoAbout the job We are currently looking for a** Site Reliability Engineer with experience in Databases** to join our team based in Andalucia but not only, since we are open to remote applicants all over Spain. The Company Novatec Software Engineering España is a branch of Novatec Consulting GmbH, with headquarter in Stuttgart (Germany). We bring our passion...
-
Client Partner
hace 7 días
En remoto, España Shutterstock A tiempo completoThe Opportunity To support our continued growth in Southern Europe, Shutterstock is strengthening its sales team and seeking an Enterprise Client Partner for the Iberia territories. Your mission will be to focus on strategic Enterprise Corporate Customer relationships via expansion and acquisition of new Key Clients. This person will be located remotely in...
-
Site Manager Sr. Ed&cp Spain
hace 1 semana
En remoto, España Docs Global A tiempo completoOverview As a Clinical Research Associate (CRA) you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures. In this role you will be a decision maker, solving problems independently or as part of the client and ICON team. You will be...
-
Site Manager
hace 2 días
En remoto, España FieldCore A tiempo completo**Job Summary**: Site Manager - Outage is responsible for preparation, planning, leading execution, and close out of complex project/outages events for gas turbine, steam turbine and generator power plants while supporting the development of the business strategy for field fulfilment excellence in FieldCore. The Site Manager - Outage is a focal role, with...
-
Medical Monitor, Spain or Poland
hace 7 días
En remoto, España Innovaderm Research A tiempo completo**This role will be perfect for you if**: - You are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project - You skillfully balance the strict requirements of clinical research protocols with the realities of clinical trials - You are able to interpret high volumes of...
-
Site Contract Leader
hace 1 semana
En remoto, España Parexel A tiempo completoParexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep...
-
Site Reliability Engineer
hace 2 semanas
En remoto, España Fortexpro A tiempo completoWe are looking for SRE to work on a major international project. 100% remote work. Offer addressed to workers from any EEC country. Tasks - Implements Site Reliability Engineering and/or DevOPS practices. - Manages technology, infrastructure and software development projects in accordance with SRE and/or DevOPS principles. - Empowers development teams...
-
Site Reliability Engineer
hace 7 días
En remoto, España Landbot A tiempo completo**About Landbot** Operating in more than 40 countries, **Landbot** _(the most powerful No-Code Chatbot Builder)_ offers a platform that helps companies to create unbeatable chatbot conversations in different channels: Web, WhatsApp, and Messenger. With us, you will be working in a team of engineers, designers, PMs. A team with diverse and exciting...
-
Clinical Research Coordinator
hace 2 semanas
En remoto, España IQVIA A tiempo completoAre you looking for an opportunity in Clinical Research? Do you want to work for an industry leading company. If so, come and join us - IQVIA are looking for a Clinical Research Coordinator. This part-time (24 hours) role, is planned for 11 months and is to support the site in **Majadahonda** in conducting a clinical trial in the field of...