1 017 Posti di lavoro per Clinical Trial in Italia
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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0
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.
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1
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
2
Clinical Research Associate
Veeda Lifesciences
Oggi
Lavoro visualizzato
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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3
Clinical Research Associate
BeOne Medicines
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Descrizione Del Lavoro
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description- The CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
- Performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region.
- The CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
- Identify gaps and areas for improvement and propose CAPA.
- Supports start-up and provides local expertise.
- SSU experience is considered a plus
- Perform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets
- Provides protocol and related study training to assigned sites.
- Conducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs
- Conducts co-monitoring visits, if required
- Completes monitoring visit reports in accordance with ICH-GCP, BeOne Medicines standards and SOP
- Manages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations
- Ensure inspection readiness of the study and sites
- Collaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)
- Attends disease indication project specific training and general CRA training as required
- Facilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required
- Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
- Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.
- BS in a relevant scientific discipline and minimum of 2 years of monitoring experience.
- Experience in oncology global trials preferred
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry
- Experience in oncology/hematology trials preferred
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English & Italian (writing and speaking)
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Travel: up to 60%
Global Competencies- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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4
Clinical Research Associate
Asti, Piemonte
JR Italy
Inserito 3 giorni fa
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CliniRx has a number of CRA positions available to support a global study in Q1 2025.
We are expanding rapidly and have multiple permanent opportunities to join us on a global study. Ideally, candidates will come from a CRO background with experience across multiple therapeutic areas.
As a global contract research organization (CRO), we offer diverse clinical development and resource solutions, reflecting both full-service CRO and functional service provider (FSP) models. We support clinical outsourcing needs for emerging biotech and pharmaceutical companies—particularly small to mid-size enterprises facing unique challenges. Our presence includes the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia.
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Primary Purpose:We are seeking skilled CRAs to ensure the timely and quality delivery of site monitoring activities in line with our Site Monitoring Plan (SMP).
Key Responsibilities:- Deliver on the Site Monitoring Plan: Understand the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality standards and timelines.
- Site Management Compliance: Manage sites according to the SMMP and relevant regulations to minimize Quality Assurance (QA) audit observations.
- Site Identification: Assist in identifying new potential sites across various therapeutic areas to expand our clinical network.
- Continuous Skill Development: Regularly enhance technical and soft skills to improve performance and project outcomes.
- Report to the Manager of Clinical Operations for project, functional, and administrative matters.
- Collaborate with the site monitoring team, site personnel, HR, site leads, and administrative staff.
Your commitment to quality and timeliness in monitoring activities is crucial for the efficient delivery of our projects and overall success.
Key Success Factors:- Timely, high-quality execution of site monitoring activities.
- Prompt report generation and submission to stakeholders.
- Education: Bachelor’s or Master’s degree in a scientific discipline.
- Experience: 1-4 years in site monitoring within clinical research.
- Skills: Strong understanding of ICH GCP and applicable clinical trial regulations; excellent communication skills; ability to multitask and work under demanding timelines.
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5
Clinical Research Associate
17100 Savona, Liguria
JR Italy
Inserito 3 giorni fa
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CliniRx CRA Positions - Global Study Support Q1 2025CliniRx has several CRA positions available to support a global study in Q1 2025. We are expanding rapidly and offer multiple permanent opportunities to join our team on a global scale. Ideally, candidates will have a CRO background with experience across various therapeutic areas.
As a global contract research organization (CRO), we provide diverse clinical development and resource solutions, including full-service CRO and functional service provider (FSP) models. We support clinical outsourcing for emerging biotech and pharmaceutical companies, especially small to mid-size enterprises facing unique challenges. Our presence spans key markets including the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia.
Primary PurposeWe are seeking skilled CRAs to ensure the timely and quality delivery of site monitoring activities in line with our Site Monitoring Plan (SMP).
Key Responsibilities- Deliver on the Site Monitoring Plan: Understand the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality and timelines.
- Site Management Compliance: Manage sites according to the SMMP and relevant regulations to minimize Quality Assurance (QA) audit observations.
- Site Identification: Assist in identifying new potential sites across various therapeutic areas to expand our clinical network.
- Continuous Skill Development: Regularly improve technical and soft skills to enhance performance and project outcomes.
- Report to the Manager of Clinical Operations regarding project, functional, and administrative matters.
- Collaborate with the site monitoring team, site personnel, HR, site leads, and administrative staff.
Your adherence to quality standards and timelines in monitoring activities is crucial for the efficient delivery and success of our projects.
Key Success Factors- Timely and high-quality site monitoring activities.
- Prompt report generation and stakeholder communication.
- Education: Bachelor’s or Master’s degree in a scientific discipline.
- Experience: 1-4 years in site monitoring within clinical research.
- Skills: Strong knowledge of ICH GCP and clinical trial regulations; excellent communication skills; ability to multitask and work under tight deadlines.
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6
Clinical Research Associate
66100 Tricalle, Abruzzo
JR Italy
Inserito 3 giorni fa
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Descrizione Del Lavoro
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CliniRx CRA Positions - Global Study 2025CliniRx has several CRA positions available to support a global study in Q1 2025. We are expanding rapidly and offer multiple permanent opportunities to join our team on a global study. Candidates with a CRO background and experience across multiple therapeutic areas are preferred.
As a global contract research organization (CRO), we provide a diverse range of clinical development and resource solutions, including full-service CRO and functional service provider (FSP) models. We support clinical outsourcing for emerging biotech and pharmaceutical companies, especially small to mid-size enterprises facing unique challenges. Our presence includes key markets such as the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia.
Primary PurposeWe are seeking skilled CRAs to ensure the timely and high-quality delivery of site monitoring activities in accordance with our Site Monitoring Plan (SMP).
Key Responsibilities- Deliver on the Site Monitoring Plan: Understand the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality and timelines.
- Site Management Compliance: Manage sites according to the SMMP and relevant regulations to minimize Quality Assurance (QA) audit observations.
- Site Identification: Assist in identifying new potential sites across various therapeutic areas to expand our clinical network.
- Continuous Skill Development: Regularly enhance technical and soft skills to improve performance and project outcomes.
- Report to the Manager of Clinical Operations regarding project, functional, and administrative matters.
- Collaborate with the site monitoring team, site personnel, HR, site leads, and administrative staff.
Your commitment to quality and adherence to timelines is vital for the successful delivery of our projects.
Key Success Factors- Timely and high-quality site monitoring activities.
- Prompt reporting and submission of reports to stakeholders.
- Education: Bachelor’s or Master’s degree in a scientific discipline.
- Experience: 1-4 years in site monitoring within clinical research.
- Skills: Strong understanding of ICH GCP and clinical trial regulations; excellent communication skills; ability to multitask under demanding timelines.
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7
Clinical Research Associate
Lecco, Lombardia
JR Italy
Inserito 3 giorni fa
Lavoro visualizzato
Descrizione Del Lavoro
Social network you want to login/join with:
CliniRx has a number of CRA positions available to support a global study in Q1 2025.
We are expanding rapidly and have multiple permanent opportunities to join us on a global study. Ideally, candidates will come from a CRO background with experience across multiple therapeutic areas.
As a global contract research organization (CRO), we offer a diverse range of clinical development and resource solutions, reflecting both full-service CRO and functional service provider (FSP) models. We support clinical outsourcing needs for emerging biotech and pharmaceutical companies, especially small to mid-size enterprises facing unique challenges. Our presence includes key markets such as the USA, UK, the Netherlands, Spain, Hong Kong, India, and Australia.
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Primary Purpose:We are seeking skilled CRAs to ensure the timely and high-quality delivery of site monitoring activities in accordance with our Site Monitoring Plan (SMP).
Key Responsibilities:- Deliver on the Site Monitoring Plan: Understand the Site Monitoring Master Plan (SMMP), study protocol, and project plan to ensure adherence to quality standards and timelines.
- Site Management Compliance: Manage sites according to the SMMP and relevant regulations to minimize Quality Assurance (QA) audit observations.
- Site Identification: Assist in identifying new potential sites across various therapeutic areas to expand our clinical network.
- Continuous Skill Development: Regularly enhance technical and soft skills to improve performance and project outcomes.
- Report to the Manager of Clinical Operations regarding project, functional, and administrative matters.
- Collaborate with the site monitoring team, site personnel, HR, site leads, and administrative staff.
Your adherence to quality standards and timelines will be crucial for the efficient delivery of our projects and overall success.
Key Success Factors:- Timely and high-quality execution of site monitoring activities.
- Prompt report generation and submission to stakeholders.
- Education: Bachelor’s or Master’s degree in a scientific discipline.
- Experience: 1-4 years of experience in site monitoring within clinical research.
- Skills: Strong understanding of ICH GCP and applicable clinical trial regulations; excellent verbal and written communication skills; ability to multitask and perform under demanding timelines.
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8
Clinical Research Associate
ICON Strategic Solutions
Inserito 4 giorni fa
Lavoro visualizzato
Descrizione Del Lavoro
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Role
- Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
- Acts as primary local company contact for assigned sites for specific trials.
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
- Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
- Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
- Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).
- May be assigned as a coach and mentor to a less experienced site manager.
- May contribute to process improvement and training.
- Leads and/or participates in special initiatives as assigned.
- May assume additional responsibilities or special initiatives such as Champion or Therapeutic Area Expert.
- A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
- Independent monitoring experience is mandatory.
- Must have experience in Clinical Research or equivalent qualification
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
- Proficient in speaking and writing the country language and English.
- Good written and oral communication skills.
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
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. #J-18808-Ljbffr
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