488 Posti di lavoro per Clinical Research Associate in Italia

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 : 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.

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.

Heads, a global CRO, part of 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

evaluates patients’ recruitment and determines if it is according to the operational plan & patients’ target

Job Requirements :

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.

We consider Data Protection an integral part of our operational business principles and are committed to respecting your privacy. For information on how we process your personal data please visit our Privacy Notice to Candidates :

heads-research.Com / canditates-privacy-notice /

Heads, a global CRO and part of Veeda Lifesciences, is seeking a Clinical Research Associate (CRA) based in Italy for its expanding international hematology/oncology clinical trials program.

This is a full-time position.

The CRA ensures that the conduct of clinical trials at selected investigational sites complies with the approved protocol/amendments, ICH GCP guidelines, SOPs, and applicable laws and regulations. They serve as the primary communication link between the Sponsor, Investigators, and study personnel, fostering successful working relationships. The key responsibility is to safeguard subjects' rights and ensure all clinical trial data are accurate, complete, and source-verifiable.

• Ensure compliance with the company’s Quality and Information Security Management Systems, ICH GCP guidelines, local and international legislation, including data protection laws, and stay updated on amendments.
• Report deviations from the protocol, GCP guidelines, or legislation to the Line Manager and relevant roles per SOPs.
• Conduct pre-study visits to evaluate investigational sites’ resources and facilities.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions and contracts, including hospital IEC submissions and approvals, study contract preparation, and financial documentation.
• Explain study purposes and procedures to Investigators; train and assist them in trial conduct.
• Maintain and update Clinical Trial Files, ensuring proper collection of essential documents.
• Supply sites with study medication, verify drug accountability, and oversee shipment, storage, dispensing, and destruction.
• Perform monitoring visits to ensure investigator compliance, verify qualifications, review data against source documents, and confirm informed consent was obtained.
• Manage recruitment, timelines, and study supplies, and maintain Investigator Files.
• Coordinate safety reporting, ensuring timely communication of adverse events to the Sponsor, and training Investigators accordingly.
• Ensure all regulatory submissions are completed timely.
• Oversee drug accountability and proper dispensing.
• Document monitoring activities and communicate findings to Investigators and the CRA Manager.
• Participate in study meetings, provide feedback, and prepare for audits or inspections.
• Support feasibility assessments, site screening, and selection.
• Assist with financial aspects, including Investigator payments.
• Manage subject enrollment and data quality, and evaluate recruitment effectiveness.
• Oversee site closure upon trial completion.
• Participate in departmental planning and SOP development, as needed.
• Provide coaching and mentorship to less experienced CRAs.

• Bachelor’s or Master’s degree in Health Sciences preferred.
• Certified CRA.
• 6-12 months’ CRA experience.
• Fluent in English and Italian, both oral and written.
• Preferably completed an ICH GCP training course.
• Proficient in computer skills.
• Strong communication, organizational, and interpersonal skills.
• Ability to work independently and as part of a team.
• Effective communication skills, diplomatic and assertive.
• Capable of handling stressful situations and managing multiple issues.
• Ability to follow SOPs, guidelines, and ethical principles.
• Willingness to travel frequently, including overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals leading the way in clinical research within a friendly environment.

Competitive remuneration package offered.

We prioritize data protection and respect your privacy. For details on data processing, please visit our Privacy Notice to Candidates.

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. Principal Responsibilities include acting as liaison between the in-house team, vendors, and multiple clinical sites; developing strong site relationships; maintaining close contact with sites by telephone, correspondence, and remote and on-site visits; applying SOPs, Clinical Monitoring Plan (CMP), protocols, study manuals, and other study materials as applicable; helping identify and qualify potential investigators; performing Pre-Study Site Visits; assisting with start-up activities, including essential document review and collection as requested; performing Site Initiation Visits, Interim Monitoring Visits, and Close Out visits as assigned; providing initial and ongoing training to clinical investigators and other site staff regarding the study protocol, procedures, documentation, as well as regulatory requirements; monitoring site compliance with study protocol and GCP; performing source data review and verifying adequacy of clinical data through comparison of case report forms to source documents per CMP; ensuring the site is entering data according to the CRF Completion Guidelines and meeting data entry and query resolution deadlines; performing drug accountability and ensuring adequate drug supply; reviewing research specimen sample documentation, storage and processing, and ensuring shipments are sent to central lab as required; assisting study team as necessary in resolving lab queries and other issues; collaborating with the drug safety group to ensure site compliance with serious adverse event reporting requirements; ensuring adequacy of clinical supplies to the site; collecting and reviewing site essential documents and ensuring site regulatory files are complete and accurate; monitoring site compliance with IRB policies / processes and ensuring timely reporting, submissions, and approvals; tracking and reporting progress of study, data monitoring, protocol variations, issue resolution, and follow up compliance; preparing and completing visit trip reports, confirmation and follow up letters within timelines outlined in the CMP; tracking, reporting, and following all action items to resolution; maintaining CTMS in a timely fashion, utilizing available reports and study tools; working proactively with sites to address site issues and action items to obtain swift resolution and escalating to PL / PI per CMP; assisting data management as required; providing co-monitoring support as requested or as necessary to develop additional skills.

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.

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. 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.

If you are unsure whether you meet all the requirements, we 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.

Overview

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.

• Acknowledge, follow and ensure 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 to the above.
• In case of deviation from the approved protocol, ICH GCP guidelines and/or applicable legislation during the study conduct, report it to the Line Manager and other applicable roles according to SOPs.
• Conduct pre-study visits at potential investigational sites to perform feasibility and/or site selection activities and evaluate resources and facilities.
• Collaborate with the Regulatory Affairs Department and Clinical Operations staff for clinical submissions and contracts, including managing hospital IEC study submissions and approvals with follow-through to ensure successful outcome; prepare study contracts and relevant files for study financial management acceptance as required by applicable local legislation.
• Explain the purposes, setup and procedures of the clinical trial to Investigators and train/assist them in the conduct of clinical trials.
• Prepare and update the Clinical Trial Files throughout the study and ensure proper collection of essential documents and other study-related documents during the trial.
• Ensure Sites are supplied with adequate study medication, verify drug accountability, and ensure safe shipment, storage, dispensing, return and destruction as applicable.
• Monitor the clinical trial conduct at Investigational Sites, including monitoring visits, to ensure investigators’ knowledge and compliance with the protocol and ICH GCP guidelines; verify that Investigator qualifications and resources remain adequate; review and verify data against source documents; obtain informed consent from all subjects before screening activities; verify consent procedures; check recruitment, timelines, storage and adequacy of trial supplies; maintain Investigator Files; coordinate safety reporting to the Sponsor; ensure investigators are trained to identify and report AEs/SAEs; ensure timely submissions to IEC/IRB or Regulatory Authorities.
• Prepare reports documenting monitoring activities and share summaries with Investigators; participate in study-specific conference calls and meetings; provide feedback to the CRA Manager.
• During audits or regulatory inspections, inform and prepare the Site and facilitate the procedure; work with study team members and QA to implement corrective actions promptly.
• Collaborate with the CRA Manager and Clinical Operations Manager to develop feasibility evaluation questionnaires, contact Investigators to collect feasibility information, and perform site screening and selection.
• Support financial issues of the study, including Investigators’ payments.
• Manage timely subject enrolment and quality data collection; ensure procedures are in place to optimize patient enrollment.
• Close down study sites on completion of the trial; participate in departmental planning sessions and SOP development as required; provide coaching, mentoring and management to newly appointed/inexperienced CRAs to optimize their role and contribution.

• Bachelor’s and/or master’s degree (preferably in Health Sciences).
• Certified CRA.
• Previous work experience: 6-12 months as a CRA.
• Excellent command of English and Italian (oral and written).
• Attendance of an ICH GCP training course (desirable).
• Good computer skills, general communication, and organizational skills.
• Ability to work independently and as part of a team; diplomatic but effective communication with study site personnel.
• Ability to handle stressful situations, adhere to timelines, and manage multiple issues simultaneously.
• Ability to work according to SOPs, guidelines, regulations and ethical principles; willingness to travel internationally and locally, 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.

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 : 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.

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.

Overview

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.

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.

• 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

• 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.

Overview

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.

• 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

• 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.

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.

• 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.

The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with a medical and/or health/life science background who want to explore the research field and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you!

Our successful Clinical Research Associates possess various backgrounds in medical and other science-related healthcare fields. Backgrounds of individuals who have succeeded in the CRA role include:

• Nursing
• Dietetics
• Pharmacist
• Pharmaceutical/Device Sales Representative
• Biomedical/Chemical Engineer
• PhD/Post-Doc
• Pharm.D candidate
• Health and Wellness Coordinators
• Clinical Research Coordinators
• Research Assistants

MEDPACE CRA TRAINING PROGRAM (PACE )

No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other P rofessionals A chieving C RA E xcellence:

• PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA.
• PACE will prepare you by developing your CRA skills through interactive discussions and hands-on job-related exercises and practicums.
• To supplement your in-house and field-based training, you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process.

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol.
• Communicate with the medical site staff including coordinators, clinical research physicians, and their site staff.
• Verify adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
• Verify medical record and research source documentation against case report form data, including informing the site staff of any entry errors and ensuring good documentation practices are adhered to.
• Verify that the investigator is enrolling only eligible subjects.
• Review regulatory documents.
• Accountability and inventory of medical devices and/or investigational products/drugs.
• Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses to confirm accurate data reporting in accordance with the protocol.
• Assess the clinical research site’s patient recruitment and retention success and offer suggestions for improvement.
• Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended actions to secure compliance.

• Master's degree in a health-related field.
• Willingness to travel 60-80% nationally.
• Familiarity with Microsoft Office.
• CRA certification completed as per DMC 15/11/2011.
• Fluency in English and Italian.
• Strong communication and presentation skills are a plus.

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach.

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

• Flexible work environment.
• Competitive compensation and benefits package.
• Competitive PTO packages.
• Structured career paths with opportunities for professional growth.
• Company-sponsored employee appreciation events.
• Employee health and wellness initiatives.

Awards

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024.
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for the next steps.

EO/AA Employer M/F/Disability/Vets