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Responsibilities (a) Site management • Study site selection, initiation (SIV) and clinical monitoring., • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience., • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations., • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP., • Track study recruitment to ensure recruitment target is achieved in all studies., • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating., • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study., • Assemble site specific EC submission dossier, and ensure submission to EC. Training • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements., • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files., • Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety • Ensure safety information is disseminated to all sites according SOP and applicable regulations., • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration • Finalize budget and obtain signed contract from site, prior to site initiation visit., • Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system • Update and maintain Study tools/systems in a timely manner. 1. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Responsibilities (a) Site management • Study site selection, initiation (SIV) and clinical monitoring., • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience., • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations., • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP., • Track study recruitment to ensure recruitment target is achieved in all studies., • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating., • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study., • Assemble site specific EC submission dossier, and ensure submission to EC. Training • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements., • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files., • Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety • Ensure safety information is disseminated to all sites according SOP and applicable regulations., • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration • Finalize budget and obtain signed contract from site, prior to site initiation visit., • Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system • Update and maintain Study tools/systems in a timely manner. 1. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Responsibilities (a) Site management • Study site selection, initiation (SIV) and clinical monitoring., • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience., • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations., • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP., • Track study recruitment to ensure recruitment target is achieved in all studies., • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating., • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study., • Assemble site specific EC submission dossier, and ensure submission to EC. Training • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements., • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files., • Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety • Ensure safety information is disseminated to all sites according SOP and applicable regulations., • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration • Finalize budget and obtain signed contract from site, prior to site initiation visit., • Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system • Update and maintain Study tools/systems in a timely manner. 1. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Responsibilities(a) Site management ¿Es este el siguiente paso en su carrera? Descubra si es el candidato adecuado leyendo la descripción completa a continuación. • Study site selection, initiation (SIV) and clinical monitoring., • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience., • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations., • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP., • Track study recruitment to ensure recruitment target is achieved in all studies., • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating., • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study., • Assemble site specific EC submission dossier, and ensure submission to EC.Training, • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements., • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.Documentation, • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files., • Prepare/complete study records' archiving according to protocol and sponsor requirements.(b) Drug Safety, • Ensure safety information is disseminated to all sites according SOP and applicable regulations., • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.(c) Finance and Administration, • Finalize budget and obtain signed contract from site, prior to site initiation visit., • Ensure Study Payment Schedule is executed and retain relevant documents/receipts.(d) Study Tools and system, • Update and maintain Study tools/systems in a timely manner. xcskxlj 3. Qualifications3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major.3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Responsibilities Cualquier información adicional que necesite para este trabajo se encuentra en el texto a continuación. Asegúrese de leerla detenidamente y luego envíe su solicitud. (a) Site management • Study site selection, initiation (SIV) and clinical monitoring., • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience., • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations., • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP., • Track study recruitment to ensure recruitment target is achieved in all studies., • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating., • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study., • Assemble site specific EC submission dossier, and ensure submission to EC. Training • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements., • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files., • Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety • Ensure safety information is disseminated to all sites according SOP and applicable regulations., • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration • Finalize budget and obtain signed contract from site, prior to site initiation visit., • Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system • Update and maintain Study tools/systems in a timely manner. xqbhyrx 1. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

pResponsibilities /pp(a) Site management /pp• Study site selection, initiation (SIV) and clinical monitoring. Las cualificaciones, habilidades y toda la experiencia relevante necesaria para este puesto se pueden encontrar en la descripción completa a continuación. /pp• Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience. /pp• Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations. /pp• Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP. /pp• Track study recruitment to ensure recruitment target is achieved in all studies. /pp• Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating. /pp• Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study. /pp• Assemble site specific EC submission dossier, and ensure submission to EC. /ppTraining /pp• Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements. /pp• Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. /ppDocumentation /pp• Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files. /pp• Prepare/complete study records’ archiving according to protocol and sponsor requirements. /pp(b) Drug Safety /pp• Ensure safety information is disseminated to all sites according SOP and applicable regulations. /pp• Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. /pp(c) Finance and Administration /pp• Finalize budget and obtain signed contract from site, prior to site initiation visit. /pp• Ensure Study Payment Schedule is executed and retain relevant documents/receipts. /pp(d) Study Tools and system /pp• Update and maintain Study tools/systems in a timely manner. xqbhyrx /p p3. Qualifications /pp3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. /pp3.2 At least 8 year of CRA experience; /pp3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; /pp3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc. /p

Responsibilities Cualquier información adicional que necesite para este trabajo se encuentra en el texto a continuación. Asegúrese de leerla detenidamente y luego envíe su solicitud. (a) Site management • Study site selection, initiation (SIV) and clinical monitoring., • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience., • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations., • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP., • Track study recruitment to ensure recruitment target is achieved in all studies., • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating., • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study., • Assemble site specific EC submission dossier, and ensure submission to EC. Training • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements., • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files., • Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety • Ensure safety information is disseminated to all sites according SOP and applicable regulations., • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration • Finalize budget and obtain signed contract from site, prior to site initiation visit., • Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system • Update and maintain Study tools/systems in a timely manner. xqbhyrx 1. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Responsibilities Cualquier información adicional que necesite para este trabajo se encuentra en el texto a continuación. Asegúrese de leerla detenidamente y luego envíe su solicitud. (a) Site management • Study site selection, initiation (SIV) and clinical monitoring., • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience., • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations., • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP., • Track study recruitment to ensure recruitment target is achieved in all studies., • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating., • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study., • Assemble site specific EC submission dossier, and ensure submission to EC. Training • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements., • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files., • Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety • Ensure safety information is disseminated to all sites according SOP and applicable regulations., • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration • Finalize budget and obtain signed contract from site, prior to site initiation visit., • Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system • Update and maintain Study tools/systems in a timely manner. xqbhyrx 1. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

ppbAbout Analog Devicesbr/ /bAnalog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at and on LinkedIn and Twitter (X). /p pbAbout Analog Devicesbr/ /bAnalog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible. Learn more at and on LinkedIn and Twitter (X). /p pStaff System Applications Engineerbr/Location: Limerick Ireland (alternate location Valencia, Spain)br/Manager: Mike Fergusonbr/Career grade level: P4br/The Automotive Audio Networking (ANN) team partner, with customers worldwide to deliver best in class technical solutions for the automotive market. Join a cutting-edge development team at Analog Devices, where you’ll help develop solutions which will be utilized in the next generation software defined vehicle architecture. The Automotive Networking Application Team have an opening for a highly motivated, energetic bSystem Applications Engineer /b who thrives on innovation and is passionate about delivering world class solutions. As a Staff System Applications Engineer, you will work on system development integration across the embedded architecture, addressing application-level challenges across the vehicle domains.br/Responsibilities include but not limited to:br/ /pulliCustomer engagements throughout the product development cycle—from concept to launch—debugging issues and resolving problems in our solution on silicon or FPGA. /liliCollaborate across multi-disciplinary teams (Marketing, Design, Software, Field Applications) and with external partners to deliver complete system solutions. /liliDeep understanding of domain area customer use cases to solve application-level challenges within the embedded vehicle architecture. /liliTranslate customer requirements and customer problem statements into solutions, thinking expansively and using a wide lens to capture both immediate and future requirements /liliSupport verification and validation efforts, including pre-silicon (FPGA systems) and post-silicon testing, to guarantee compliance with requirements /liliCreate compelling system demonstrators and proof of concepts for customer visits and tradeshow events. /liliProvide technical communication and support during customer engagements to ensure success /liliArchitect balanced system trade-offs between performance, power, complexity, and cost to meet demanding design goals /liliCreate tools that make it faster and easier for our customers to design-in our products. /liliIdentify emerging technology trends and translate these into product proposals that drive the development of ADI’s business and technology roadmaps. /liliProficient at programming in embedded C within a limited resource environment, C++ and Phyton /liliExperience with microcontrollers (e.g., ARM processors), and low-level communication peripherals (including SPI, I2C, TDM, UART, CAN, etc.) /liliOperation System knowledge, Linux, AutoSAR, real-time operating systems (RTOS) as well as bare metal implementations. /li /ul pDesired Requirements/Qualificationsbr/ /pulli8+ years of experience in Product Development roles within the Electronics industry /liliBachelor’s, Master’s or PhD degree in Electronic/Electrical Engineering, Embedded Firmware/Software Engineering, or a related field (or equivalent industry experience) /liliExcellent debugging / analytical skills, excellent communication skills essential, each day will bring new and differing challenges. /liliLove of learning and problem-solving and enthusiastic about all things to do with Technology /li /ul pTechnical Expertise (knowledge and experience)br/ /pulliSystem Engineering methodologies and HW/SW product development flows, including requirements capture (e.g., Jama), integration, verification, and validation /liliThe candidate is expected to employ solutions thinking and have demonstrated proficiency in electronic circuit design, embedded software development. A strong background of hands‑on technical applications work is preferred. /liliShowing an ability to solve complex problems, debug systems and replicate/deliver solutions on bench in hardware and software. For example driver development /liliExperience in developing/troubleshooting low-level drivers and hardware integration for interfaces such as I2C, SPI, UART, PWM, etc. /liliTesting and debugging techniques, with proficiency in tools such as oscilloscopes, Vector Network Analyzer, and automotive communication protocol analysers /liliKnowledgeable in best coding practices and quality attributes of embedded software. /liliYou don’t mind ambiguity and thrive in a multifaceted cross-functional team with a start‑up culture /liliKnowledge in one or more of the following areas will make you stand out, but isn’t required. /liliAutomotive or Industrial system design, processes, and platforms (ASPICE, AUTOSAR, etc.) /liliFunctional Safety (ISO 26262, or similar) /liliCyber Security (ISO/SAE 21434 or similar) /liliKnowledge of communication protocols interfaces (CAN, LIN, and Ethernet protocols, etc). /liliSystem modelling and simulations (Matlab, Simulink, Spice, etc..) /li /ul pFor positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S. Department of Commerce - Bureau of Industry and Security and/or the U.S. Department of State - Directorate of Defense Trade Controls. As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process. /p pAnalog Devices is an equal opportunity employer. We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group. /p pJob Req Type: Experiencedbr/Required Travel: Yes, 10% of the timebr/Shift Type: 1st Shift/Days /p /p #J-18808-Ljbffr

Kapres Technology está buscando un Especialista en Cumplimiento Normativo para el sector automotriz.Se valorará experiencia en cumplimiento normativo, seguridad de la información y auditorías en entornos técnicos.El puesto ofrece contrato indefinido y un modelo de trabajo híbrido con dos días