285 Posti di lavoro per Research And Development in Italia
Research And Development Manager
Novara, Piemonte
Emmi Dessert Italia S.P.A.
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Overview
Emmi Dessert Italia (EDITA) è leader nella produzione di dessert freschi e parte del gruppo Emmi, multinazionale svizzera con 40 sedi in tutto il mondo. In Italia, EDITA conta più di 450 dipendenti suddivisi fra le 3 sedi produttive e l’Headquarter di Gattico-Veruno (NO). Siamo una realtà in forte crescita, dinamica ed innovativa, determinata a creare valore per i clienti e la comunità che ci circonda. In EDITA le persone sono il punto di partenza e anche il punto di arrivo di tutto ciò che facciamo. Stiamo cercando un R&D Manager che guidi la Funzione R&D di EDITA nell’individuare e perseguire opportunità di sviluppo del portfolio prodotti in linea con le strategie e gli obiettivi di crescita dell’Azienda. La persona che stiamo cercando riporterà all’Head of Supply Chain e sarà basata presso l’Headquarter di Gattico-Veruno (NO).
Principali responsabilità- Collaborare con le aree Marketing Innovation e Sales nello sviluppo creativo di nuove idee a supporto della crescita del business aziendale (private label / branded).
- Guidare il Team R&D nelle attività di progetto e realizzazione delle innovazioni di prodotto, sostenendo l’eccellenza tecnica e la Quality culture.
- Operare in sinergia con le altre funzioni di Supply Chain e Operations per verificare la fattibilità tecnico-produttiva ed individuare le soluzioni migliori per l’implementazione delle innovazioni.
- Assicurare competitività ai prodotti aziendali mantenendosi costantemente aggiornato sulle attività della concorrenza e sulle tendenze di mercato e del settore (es. nutritional trends) che impattano sulle scelte dei consumatori.
- Sviluppare contatti con i fornitori di materie prime, imballaggi e tecnologie al fine di mantenersi continuamente aggiornato sulle possibili innovazioni o miglioramenti da implementare nel processo produttivo.
- Contribuire alla crescita professionale del Team R&D attraverso la definizione del migliore assetto organizzativo e delle competenze necessarie;
- l’implementazione di piani di formazione e sviluppo;
- promuovere la collaborazione e lo spirito di squadra.
- appassionata, curiosa, aperta al confronto.
- dotata di visione strategica, pensiero creativo e forte spinta all’innovazione.
- con esperienza consolidata di Product Development e Project Management.
- con eccellenti doti comunicative e capacità di leadership integrativa.
- Laurea in Scienze e Tecnologie Alimentari o Biologia / Chimica.
- Almeno 5 / 8 anni di esperienza pregressa nel settore alimentare / chimico.
- Buona conoscenza della lingua inglese.
Thanks to everyone who will take the time to respond to our job posting. We truly appreciate your interest in joining EDITA team. Please be aware that we will directly contact only those candidates whose profiles match role's requirements.
Thanks in advance to all the recruiting agencies who will offer their support but Emmi Dessert Italia will follow this recruiting process firsthand.
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0
Research and Development Specialist
Roma, Lazio
beBeeMathematics
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Job Title: Research and Development Specialist
Overview:
We are seeking a highly skilled Research and Development Specialist to join our team. As a key member of our organization, you will be responsible for designing and implementing cutting-edge research projects in the field of mathematics and statistics.
Responsibilities:
- Design and implement advanced math problems to test AI performance
- Collaborate with researchers to refine benchmarks across undergraduate to PhD-level math topics
- Utilize mathematical and analytical skills to fine-tune large language models
Requirements:
- PhD (pursuing or completed) in Mathematics, Applied Math, Statistics, or related field
- Ability to communicate complex ideas clearly in writing and provide structured feedback
Benefits:
- Fully remote work environment with flexible weekly hours
- Opportunity to work on cutting-edge AI projects with leading LLM companies
Assessment:
Shortlisted experts will complete an evaluation before selection.
Company Overview:
Our organization is a leading research accelerator for frontier AI labs and a trusted partner for global enterprises deploying advanced AI systems. We support customers by accelerating frontier research and applying expertise to help enterprises transform AI from proof of concept into proprietary intelligence with systems that perform reliably, deliver measurable impact, and drive lasting results.
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1
Research Associate
Toscana, Toscana
Philogen S.p.A.
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a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies, is expanding its clinical activities and will be opening a new office in Milan .
would like to hire a CLINICAL RESEARCH ASSOCIATE for the development of clinical experimental activity. The successful candidate will have responsibility for the management of Philogen's Phase I, II and III clinical trials in oncology and inflammatory diseases.
He/she will be expected to make frequent visits to European and US centres involved in clinical trials.
Site initiation, monitoring, and close-out in accordance to GCP.
Monitoring visits and site management of national and European centres.
Evaluating integrity and quality of patient data and investigator study file.
An excellent level of English, both written and spoken is a mandatory requirement
A basic level of German language would be preferable
The ability to travel frequently.
A contract and salary proportional to the experience of the successful candidate.
We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003.
would like to hire a CLINICAL RESEARCH ASSOCIATE for the development of clinical experimental activity. The successful candidate will have responsibility for the management of Philogen's Phase I, II and III clinical trials in oncology and inflammatory diseases.
He/she will be expected to make frequent visits to European and US centres involved in clinical trials.
Site initiation, monitoring, and close-out in accordance to GCP.
Monitoring visits and site management of national and European centres.
Evaluating integrity and quality of patient data and investigator study file.
An excellent level of English, both written and spoken is a mandatory requirement
A basic level of German language would be preferable
The ability to travel frequently.
A contract and salary proportional to the experience of the successful candidate.
We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003.
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2
Clinical Research Associate
Siena, Toscana
Philogen S.p.A.
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Descrizione Del Lavoro
Philogen S.p.A., a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies, is expanding its clinical activities and will be opening a new office in Milan . Philogen S.p.A. would like to hire a CLINICAL RESEARCH ASSOCIATE for the development of clinical experimental activity. The successful candidate will have responsibility for the management of Philogen’s Phase I, II and III clinical trials in oncology and inflammatory diseases. He/she will be expected to make frequent visits to European and US centres involved in clinical trials. In particular the successful candidate will take care of: Site initiation, monitoring, and close-out in accordance to GCP. Monitoring visits and site management of national and European centres. Tracking patient recruitment and enrollment. Evaluating integrity and quality of patient data and investigator study file. The ideal candidate should have: A good scientific background. An excellent level of English, both written and spoken is a mandatory requirement A basic level of German language would be preferable The ability to travel frequently. A high level of attention to detail. The ability to work independently. We offer: A contract and salary proportional to the experience of the successful candidate. Job location: Siena/Milano - Italy We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196/2003. Our recruitment adheres to the provisions of Legislative Decree 198/2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.
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3
Clinical Research Associate
ICON Strategic Solutions
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ICON 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 development. The Field CRA is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines. We are currently looking for a Clinical Research Associate to join one of our Sponsor-dedicated teams. Principal Responsibilities: Act as liaison between the in-house team, vendors, and multiple clinical sites. Develop strong site relationships, maintaining close contact with sites by telephone, correspondence, and remote and on-site visits. Apply SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, other study materials as applicable. Help identify and qualify potential investigators. Perform Pre-Study Site Visits. Assist with start-up activities, including essential document review and collection as requested. Perform Site Initiation Visits, Interim Monitoring Visits, Close Out visits as assigned. Provide initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements. Monitor site compliance with study protocol and GCP. Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP. Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines. Perform drug accountability and ensure adequate drug supply. Review research specimen sample documentation, storage and processing, and ensure shipments are sent to central lab as required. Assist study team as necessary in resolving lab queries and other issues. Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements. Ensure adequacy of clinical supplies to the site. Collect and review site essential documents and ensure site regulatory files are complete and accurate. Monitor site compliance with IRB policies/processes and ensure timely reporting, submissions, and approvals. Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance. Prepare and complete visit trip reports, confirmation and follow up letters within timelines outlined in the CMP. Track, report, and follow all action items to resolution. Maintain CTMS in a timely fashion, utilizing available reports and study tools. Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to PL/PI per CMP. Assist data management as required. Provide co-monitoring support as requested or as necessary to develop additional skills Qualifications: Minimum of 2-3 years of independent monitoring experience is mandatory. A minimum of a Masters degree is required. A degree in a health or science related field is preferred Proficient in speaking and writing in Italian and English. Valid drivers license Knowledge of and ability to apply CFR and GCP/ICH is required. Experience on global clinical trials is preferred. Proficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint (preferred). Previous experience with EDC and CTMS systems. Requires effective organizational and time management skills. Able to manage multiple and varied tasks with enthusiasm under limited direction and on own initiative. Ability to prioritize workload with attention to detail. Strong communication and interpersonal skills. Ability to discuss scientific, medical and therapeutic area information within small and large groups of medical professionals. Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location. Responsive and proactive, a team player. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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4
Clinical Research Associate
Veeda Lifesciences
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Veeda Lifesciences is seeking a Clinical Research Associate (CRA) based in Italy for its growing international hematology/oncology Clinical Trials program. This is a full-time job. Job overview: The CRA is responsible for ensuring that the conduct of a clinical trial at selected Investigational Sites is according to the currently approved protocol/amendments, ICH GCP guidelines, the applicable Standard Operating Procedures (SOPs) and the applicable laws and regulations. He/she is the primary responsible person for communication on operational study related activities between the Sponsor, the Investigator and other study personnel to build and maintain successful working relationships. The most important responsibility is to ensure that the subjects’ rights are respected and that all collected clinical trial data are accurate, complete, and verifiable from source documents. Main responsibilities: -Acknowledges, follows& ensures compliance with the Company’s Quality and Information Security Management Systems, ICH GCP guidelines, applicable local and international legislation, including data protection legislation, as well as any amendments or updates the above -In case of deviation from the approved protocol, ICH GCP guidelines and/or applicable legislation during the study conduct, the CRA is responsible for reporting it to the Line Manager and other applicable roles according to SOPs -Conducts pre-study visits at potential investigational sites, to perform the study related feasibility and/or selection activities and evaluate their resources and facilities -Collaborates with the Regulatory Affairs Department and concerned Clinical Operations staff for clinical submissions and contracts respectively for: Managing Hospital IEC study submissions and approvals with follow through to ensure successful outcome Preparation of study contracts & relevant files to be submitted for the study financial management acceptance, as required by the applicable local legislation -Fully explains the purposes, set-up, and procedures of the clinical trial to the Investigators and is responsible for training and assisting them in the conduct of clinical trials -Prepares and updates the Clinical Trial Files throughout the study and ensures the proper collection of essential documents and other study-related documents during the trial -Ensures that the Sites are supplied with adequate study medication, verifies that drug accountability is performed correctly and ensures the drug’s safe shipment, storage, dispensing, return and destruction, as applicable -The CRA is responsible for adequate monitoring of the clinical trial conduct at the Investigational Sites (e.g., performs monitoring visits at the Sites) during which he/she: Ensures Investigators’ knowledge and compliance with the clinical protocol and ICH GCP guidelines Verifies that Investigators’ qualifications and resources remain adequate throughout the trial period Reviews and verifies the data reported in the eCRF against source data, according to the monitoring plan which determines the depth and extend of source data verification Ensures that written informed consent has been obtained from all subjects prior to any study related screening activity or requirement Fully verifies subject consent procedures against ICH GCP guidelines and legislation Checks and discusses recruitment and timelines with the Investigators Checks the storage and adequacy of clinical trial supplies Maintains and updates the Investigator’s Files as required to confirm completeness Co-ordinates the proper reporting of Safety Information to the Sponsor according to the Safety Reporting Plan, where applicable. CRA is also responsible for making sure that the Investigators are adequately trained in identifying and reporting AEs/SAEs Checks that all submissions, reports, notifications and applications to the IEC/IRB or Regulatory Authorities have been made by the Investigator in a timely manner Performs drug accountability and ensures the proper dispensing of study drug to the patient -Prepares reports to document all discussions, measures and actions made during a monitoring visit, telephone contact or remote monitoring. The CRA also sends summary of these reports to the Investigators -Participates in study specific conference calls and meetings to review progress of ongoing clinical trials; provides feedback to the CRA Manager -In case of an audit or regulatory inspection, the CRA is responsible for informing and preparing the Site and facilitating the procedure. The CRA works with the appropriate study team members and Quality (QA) in order the corrective actions are in place and performed as soon as possible -Collaborates with the CRA Manager and Clinical Operations Manager to develop feasibility evaluation questionnaires, contact the Investigators to collect feasibility-related information, perform site screening and selection -Supports financial issues of the study, including Investigators’ payments -Manages timely subject enrolment and quality data collection -Ensures that procedures are in place for appropriate optimization of patients into the study: evaluates patients’ recruitment and determines if it is according to the operational plan & patients’ target -Closes down study sites on completion of the trial -Participates in departmental planning sessions, and SOP development, if required -Provides coaching, mentoring and management to the newly appointed and/or inexperienced CRAs to ensure that their role and contribution is optimized Job Requirements: -Bachelor’s and/or master’s degree (preferably in Health Sciences) -Certified CRA -Previous Work Experience: 6-12 months’ work experience as a CRA -Excellent command of English and Italian both oral and written -Attendance of an ICH GCP training course (desirable) -Good computer skills -Good general communication skills -Good organizational skills -Ability to work independently and be a good team player at the same time -Ability to communicate diplomatically, but also effectively with study Site personnel -Ability to deal adequately with stressful situations, flexible timelines and work pressure -Ability to maintain complete overview and deal with several issues at the same time -Ability to work according to specific SOPs, guidelines, regulations & ethical principles in the daily practice -Ability for frequent international and local travelling, including evenings and overnight stays Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment. Competitive remuneration package comes on top.
Siamo spiacenti, questo lavoro non è disponibile nella tua regione
5
Clinical Research Associate
Veeda Lifesciences
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Descrizione Del Lavoro
Veeda Lifesciences is seeking a Clinical Research Associate (CRA) based in Italy for its growing international hematology/oncology Clinical Trials program. This is a full-time job. Job overview: The CRA is responsible for ensuring that the conduct of a clinical trial at selected Investigational Sites is according to the currently approved protocol/amendments, ICH GCP guidelines, the applicable Standard Operating Procedures (SOPs) and the applicable laws and regulations. He/she is the primary responsible person for communication on operational study related activities between the Sponsor, the Investigator and other study personnel to build and maintain successful working relationships. The most important responsibility is to ensure that the subjects’ rights are respected and that all collected clinical trial data are accurate, complete, and verifiable from source documents. Main responsibilities: -Acknowledges, follows& ensures compliance with the Company’s Quality and Information Security Management Systems, ICH GCP guidelines, applicable local and international legislation, including data protection legislation, as well as any amendments or updates the above -In case of deviation from the approved protocol, ICH GCP guidelines and/or applicable legislation during the study conduct, the CRA is responsible for reporting it to the Line Manager and other applicable roles according to SOPs -Conducts pre-study visits at potential investigational sites, to perform the study related feasibility and/or selection activities and evaluate their resources and facilities -Collaborates with the Regulatory Affairs Department and concerned Clinical Operations staff for clinical submissions and contracts respectively for: Managing Hospital IEC study submissions and approvals with follow through to ensure successful outcome Preparation of study contracts & relevant files to be submitted for the study financial management acceptance, as required by the applicable local legislation -Fully explains the purposes, set-up, and procedures of the clinical trial to the Investigators and is responsible for training and assisting them in the conduct of clinical trials -Prepares and updates the Clinical Trial Files throughout the study and ensures the proper collection of essential documents and other study-related documents during the trial -Ensures that the Sites are supplied with adequate study medication, verifies that drug accountability is performed correctly and ensures the drug’s safe shipment, storage, dispensing, return and destruction, as applicable -The CRA is responsible for adequate monitoring of the clinical trial conduct at the Investigational Sites (e.g., performs monitoring visits at the Sites) during which he/she: Ensures Investigators’ knowledge and compliance with the clinical protocol and ICH GCP guidelines Verifies that Investigators’ qualifications and resources remain adequate throughout the trial period Reviews and verifies the data reported in the eCRF against source data, according to the monitoring plan which determines the depth and extend of source data verification Ensures that written informed consent has been obtained from all subjects prior to any study related screening activity or requirement Fully verifies subject consent procedures against ICH GCP guidelines and legislation Checks and discusses recruitment and timelines with the Investigators Checks the storage and adequacy of clinical trial supplies Maintains and updates the Investigator’s Files as required to confirm completeness Co-ordinates the proper reporting of Safety Information to the Sponsor according to the Safety Reporting Plan, where applicable. CRA is also responsible for making sure that the Investigators are adequately trained in identifying and reporting AEs/SAEs Checks that all submissions, reports, notifications and applications to the IEC/IRB or Regulatory Authorities have been made by the Investigator in a timely manner Performs drug accountability and ensures the proper dispensing of study drug to the patient -Prepares reports to document all discussions, measures and actions made during a monitoring visit, telephone contact or remote monitoring. The CRA also sends summary of these reports to the Investigators -Participates in study specific conference calls and meetings to review progress of ongoing clinical trials; provides feedback to the CRA Manager -In case of an audit or regulatory inspection, the CRA is responsible for informing and preparing the Site and facilitating the procedure. The CRA works with the appropriate study team members and Quality (QA) in order the corrective actions are in place and performed as soon as possible -Collaborates with the CRA Manager and Clinical Operations Manager to develop feasibility evaluation questionnaires, contact the Investigators to collect feasibility-related information, perform site screening and selection -Supports financial issues of the study, including Investigators’ payments -Manages timely subject enrolment and quality data collection -Ensures that procedures are in place for appropriate optimization of patients into the study: evaluates patients’ recruitment and determines if it is according to the operational plan & patients’ target -Closes down study sites on completion of the trial -Participates in departmental planning sessions, and SOP development, if required -Provides coaching, mentoring and management to the newly appointed and/or inexperienced CRAs to ensure that their role and contribution is optimized Job Requirements: -Bachelor’s and/or master’s degree (preferably in Health Sciences) -Certified CRA -Previous Work Experience: 6-12 months’ work experience as a CRA -Excellent command of English and Italian both oral and written -Attendance of an ICH GCP training course (desirable) -Good computer skills -Good general communication skills -Good organizational skills -Ability to work independently and be a good team player at the same time -Ability to communicate diplomatically, but also effectively with study Site personnel -Ability to deal adequately with stressful situations, flexible timelines and work pressure -Ability to maintain complete overview and deal with several issues at the same time -Ability to work according to specific SOPs, guidelines, regulations & ethical principles in the daily practice -Ability for frequent international and local travelling, including evenings and overnight stays Join us to be part of a multidisciplinary team of highly skilled scientists and healthcare professionals in the forefront of Clinical Research within a friendly work environment. Competitive remuneration package comes on top.
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6
Clinical Research Associate
ICON Strategic Solutions
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Descrizione Del Lavoro
ICON 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 development. The Field CRA is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines. We are currently looking for a Clinical Research Associate to join one of our Sponsor-dedicated teams. Principal Responsibilities: Act as liaison between the in-house team, vendors, and multiple clinical sites. Develop strong site relationships, maintaining close contact with sites by telephone, correspondence, and remote and on-site visits. Apply SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, other study materials as applicable. Help identify and qualify potential investigators. Perform Pre-Study Site Visits. Assist with start-up activities, including essential document review and collection as requested. Perform Site Initiation Visits, Interim Monitoring Visits, Close Out visits as assigned. Provide initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements. Monitor site compliance with study protocol and GCP. Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP. Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines. Perform drug accountability and ensure adequate drug supply. Review research specimen sample documentation, storage and processing, and ensure shipments are sent to central lab as required. Assist study team as necessary in resolving lab queries and other issues. Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements. Ensure adequacy of clinical supplies to the site. Collect and review site essential documents and ensure site regulatory files are complete and accurate. Monitor site compliance with IRB policies/processes and ensure timely reporting, submissions, and approvals. Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance. Prepare and complete visit trip reports, confirmation and follow up letters within timelines outlined in the CMP. Track, report, and follow all action items to resolution. Maintain CTMS in a timely fashion, utilizing available reports and study tools. Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to PL/PI per CMP. Assist data management as required. Provide co-monitoring support as requested or as necessary to develop additional skills Qualifications: Minimum of 2-3 years of independent monitoring experience is mandatory. A minimum of a Masters degree is required. A degree in a health or science related field is preferred Proficient in speaking and writing in Italian and English. Valid drivers license Knowledge of and ability to apply CFR and GCP/ICH is required. Experience on global clinical trials is preferred. Proficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint (preferred). Previous experience with EDC and CTMS systems. Requires effective organizational and time management skills. Able to manage multiple and varied tasks with enthusiasm under limited direction and on own initiative. Ability to prioritize workload with attention to detail. Strong communication and interpersonal skills. Ability to discuss scientific, medical and therapeutic area information within small and large groups of medical professionals. Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location. Responsive and proactive, a team player. What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Siamo spiacenti, questo lavoro non è disponibile nella tua regione
7
Clinical Research Associate
10128
ICON Strategic Solutions
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Lavoro visualizzato
Descrizione Del Lavoro
ICON 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 development.
The Field CRA is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines.
We are currently looking for a Clinical Research Associate to join one of our Sponsor-dedicated teams.
Principal Responsibilities:
- Act as liaison between the in-house team, vendors, and multiple clinical sites.
- Develop strong site relationships, maintaining close contact with sites by telephone, correspondence, and remote and on-site visits.
- Apply SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, other study materials as applicable.
- Help identify and qualify potential investigators. Perform Pre-Study Site Visits.
- Assist with start-up activities, including essential document review and collection as requested.
- Perform Site Initiation Visits, Interim Monitoring Visits, Close Out visits as assigned.
- Provide initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements.
- Monitor site compliance with study protocol and GCP.
- Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP.
- Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines.
- Perform drug accountability and ensure adequate drug supply.
- Review research specimen sample documentation, storage and processing, and ensure shipments are sent to central lab as required.
- Assist study team as necessary in resolving lab queries and other issues.
- Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements.
- Ensure adequacy of clinical supplies to the site.
- Collect and review site essential documents and ensure site regulatory files are complete and accurate.
- Monitor site compliance with IRB policies/processes and ensure timely reporting, submissions, and approvals.
- Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance.
- Prepare and complete visit trip reports, confirmation and follow up letters within timelines outlined in the CMP.
- Track, report, and follow all action items to resolution.
- Maintain CTMS in a timely fashion, utilizing available reports and study tools.
- Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to PL/PI per CMP.
- Assist data management as required.
- Provide co-monitoring support as requested or as necessary to develop additional skills
Qualifications:
- Minimum of 2-3 years of independent monitoring experience is mandatory.
- A minimum of a Masters degree is required. A degree in a health or science related field is preferred
- Proficient in speaking and writing in Italian and English.
- Valid drivers license
- Knowledge of and ability to apply CFR and GCP/ICH is required. Experience on global clinical trials is preferred.
- Proficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint (preferred). Previous experience with EDC and CTMS systems.
- Requires effective organizational and time management skills.
- Able to manage multiple and varied tasks with enthusiasm under limited direction and on own initiative. Ability to prioritize workload with attention to detail.
- Strong communication and interpersonal skills.
- Ability to discuss scientific, medical and therapeutic area information within small and large groups of medical professionals.
- Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location.
- Responsive and proactive, a team player.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON:
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Siamo spiacenti, questo lavoro non è disponibile nella tua regione
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Clinical Research Associate
ICON Strategic Solutions
Oggi
Lavoro visualizzato
Descrizione Del Lavoro
ICON 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 development.
The Field CRA is responsible for monitoring and management of clinical sites. This position focuses on all activities required to evaluate, initiate, monitor and close clinical sites in compliance with the Code of Federal Regulations and ICH/GCP Guidelines.
We are currently looking for a Clinical Research Associate to join one of our Sponsor-dedicated teams.
Principal Responsibilities:
- Act as liaison between the in-house team, vendors, and multiple clinical sites.
- Develop strong site relationships, maintaining close contact with sites by telephone, correspondence, and remote and on-site visits.
- Apply SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, other study materials as applicable.
- Help identify and qualify potential investigators. Perform Pre-Study Site Visits.
- Assist with start-up activities, including essential document review and collection as requested.
- Perform Site Initiation Visits, Interim Monitoring Visits, Close Out visits as assigned.
- Provide initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements.
- Monitor site compliance with study protocol and GCP.
- Perform source data review and verify adequacy of clinical data through comparison of case report forms to source documents per CMP.
- Ensure the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines.
- Perform drug accountability and ensure adequate drug supply.
- Review research specimen sample documentation, storage and processing, and ensure shipments are sent to central lab as required.
- Assist study team as necessary in resolving lab queries and other issues.
- Collaborate with the drug safety group to ensure site compliance with serious adverse event reporting requirements.
- Ensure adequacy of clinical supplies to the site.
- Collect and review site essential documents and ensure site regulatory files are complete and accurate.
- Monitor site compliance with IRB policies/processes and ensure timely reporting, submissions, and approvals.
- Track and report progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance.
- Prepare and complete visit trip reports, confirmation and follow up letters within timelines outlined in the CMP.
- Track, report, and follow all action items to resolution.
- Maintain CTMS in a timely fashion, utilizing available reports and study tools.
- Work proactively with sites to address site issues and action items to obtain swift resolution and escalate to PL/PI per CMP.
- Assist data management as required.
- Provide co-monitoring support as requested or as necessary to develop additional skills
Qualifications:
- Minimum of 2-3 years of independent monitoring experience is mandatory.
- A minimum of a Masters degree is required. A degree in a health or science related field is preferred
- Proficient in speaking and writing in Italian and English.
- Valid drivers license
- Knowledge of and ability to apply CFR and GCP/ICH is required. Experience on global clinical trials is preferred.
- Proficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint (preferred). Previous experience with EDC and CTMS systems.
- Requires effective organizational and time management skills.
- Able to manage multiple and varied tasks with enthusiasm under limited direction and on own initiative. Ability to prioritize workload with attention to detail.
- Strong communication and interpersonal skills.
- Ability to discuss scientific, medical and therapeutic area information within small and large groups of medical professionals.
- Travel requirements will vary depending on study requirements, site assignments, site remote monitoring capabilities, and geographical location.
- Responsive and proactive, a team player.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON:
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Siamo spiacenti, questo lavoro non è disponibile nella tua regione
9