14 Posti di lavoro per Paediatric research nurse in Napoli

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
• 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.

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 managing clinical sites. This position focuses on 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, and other study materials as applicable.
• Identify and qualify potential investigators. Perform Pre-Study Site Visits.
• Assist with start-up activities, including review and collection of essential documents.
• Perform Site Initiation Visits, Interim Monitoring Visits, and Close Out visits as assigned.
• Provide training to clinical investigators and site staff regarding the study protocol, procedures, documentation, and regulatory requirements.
• Monitor site compliance with study protocol and GCP.
• Review source data and verify clinical data accuracy through comparison of case report forms to source documents per CMP.
• Ensure data entry is according to CRF Completion Guidelines and deadlines are met.
• Perform drug accountability and ensure adequate drug supply.
• Review research specimen documentation, storage, processing, and ensure proper shipments to central labs.
• Assist in resolving lab queries and other issues.
• Collaborate with the drug safety group on adverse event reporting.
• Ensure clinical supplies are adequate.
• Collect and review site essential documents and ensure regulatory files are complete.
• Monitor IRB compliance and ensure timely reporting and approvals.
• Track and report study progress, data monitoring, protocol variations, and issue resolution.
• Prepare visit reports and follow-up correspondence within CMP timelines.
• Manage action items and escalate issues as needed.
• Maintain CTMS records accurately and timely.
• Work proactively with sites to address issues and escalate as necessary.
• Assist data management as required.
• Provide co-monitoring support to develop additional skills.

• Minimum of 2-3 years of independent monitoring experience.
• Masters degree required; health or science-related field preferred.
• Proficiency in Italian and English (spoken and written).
• Valid driver’s license.
• Knowledge of CFR, GCP, ICH; experience in global trials preferred.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, SharePoint); experience with EDC and CTMS systems preferred.
• Strong organizational and time management skills.
• Ability to manage multiple tasks independently with attention to detail.
• Excellent communication and interpersonal skills.
• Ability to discuss scientific and medical information effectively.
• Travel may be required based on study needs and locations.
• Responsive, proactive, team-oriented attitude.

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement plans
• Global Employee Assistance Programme (TELUS Health)
• Life assurance
• Optional benefits like childcare vouchers, gym discounts, travel passes, health assessments, among others

Visit our careers website for more about working at ICON :

careers.Iconplc.Com / benefits

ICON is committed to inclusion and accessibility. We provide a workplace free of discrimination and harassment. Qualified applicants will receive equal consideration regardless of race, religion, gender, sexual orientation, disability, or veteran status. If you need accommodations during the application process, please let us know.

careers.Iconplc.Com / reasonable-accommodations

Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly what we’re looking for!

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.

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.

Overview

IQVIA HCPN has several exciting positions in Italy for freelance CRAs.

Location: Italy

Hours: around 20h per week

Contract: Freelance

Start: asap

Duration: around 6 months, most work to be done until the end of this year

Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and / or Lead CRA to ensure all monitoring activities are conducted according to study requirements.

• Participates in the investigator recruitment process, performing site evaluation visits of potential investigators to evaluate the capability of the site to successfully manage and conduct the clinical study.
• Coordinate activities with the site and internal departments in preparation for the initiation of the study. Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF and EDC system; monitoring activities and study close-out activities.
• Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
• Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs.
• Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory.
• Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification and works with sites to resolve data queries and produce robust data.
• May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and / or Lead CRA.
• Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
• Assists with, and attends, Investigator Meetings for assigned studies.
• Attends study-related, company, departmental, and external meetings, as required.
• Ensures all study deliverables are completed per IQVIA Biotech and study timelines
• Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
• Serves as mentor for junior CRAs and those new to the company and / or study.

• Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.
• Minimum of 2 years experience as a CRA
• Experience in monitoring and / or coordinating clinical trials required.
• Oncology experienced needed
• Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
• Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
• Able to handle several priorities within multiple, complex trials.
• Able to reason independently and recommend specific solutions in clinical settings.
• Able to work independently, prioritize, and work within a matrix team environment.
• Knowledge of current GCP / ICH guidelines applicable to the conduct of clinical research.

If this role sounds of interest, please apply today!

Overview

POSITION SUMMARY : The Senior Clinical Research Associate (Senior CRA) is responsible for scheduling and conducting on-site and remote monitoring visits in compliance with applicable regulatory standards (MDR, ISO 14155, ICH / GCP guidelines, Teleflex procedures and IRB / EC policies and procedures). The Senior CRA conducts monitoring visits as identified by the monitoring plan, study team or department needs to evaluate data accuracy and subject safety required by review of regulatory documents, medical records, reported data and device storage, if applicable. The Senior CRA must be able to identify issues, present findings to the site staff, provide retraining if needed, provide problem solving strategies and communicate findings to the study team and department management via escalation of issues and / or within the monitoring visit report. The Senior CRA has a minimum of 5 years of work experience as a clinical trial monitor. The Senior CRA assists the Management Team with training needs as well as developing and providing input on monitoring tools and procedures.

• Monitor visits (on-site and remote) in accordance with the monitoring plan and Teleflex procedures.
• Evaluate quality and integrity of site practices and escalate quality issues as appropriate.
• Prepare for monitoring visits with study team collaboration, and ensure visits are organized, well planned, efficient and thorough.
• Prepare site emails 1-2 weeks prior to on-site and remote monitoring visits; reevaluate time needed for on-site visits; maximize on-site time through thorough preparation.
• Conduct monitoring visits per department SOP, WIs, and monitoring plans; apply MDR, ISO 14155, ICH / GCP guidelines and Teleflex SOP/WIs.
• Complete Investigator Files with appropriate documentation; ensure required documentation is completed prior to site initiation, during enrolment and follow-up, and at site close out.
• Presents findings to site staff and provides clear directions for resolution; provide retraining as needed.
• Review data queries with site staff and serve as a resource between visits to clarify data queries, action items and visit preparation.
• Complete Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per Teleflex procedures; document action items clearly with resolution instructions.
• Collect and file necessary documents; ensure compliance with national and local safety reporting requirements; prepare and submit local safety documents to EC / NCA upon request; coordinate with Safety Officer as needed.
• Follow up with study sites on Safety / Adverse event related tasks; ensure national/local requirements for safety reporting are met.
• Gather local data protection information and report to CPM prior to study start.
• Assist the Clinical Project Manager in departmental and study-related projects (in-house audits, investigator meetings, training, etc.).
• Conduct co-monitoring with Clinical Studies personnel to ensure monitoring aligns with protocol, SOP, WIs and regulatory standards; oversee training of newly hired personnel.
• Provide leadership to the RCRA Group for day-to-day clinical studies responsibilities; support adaptation of WIs and Guidelines as regulations require.
• Prepare for safety inspections and audits by regulatory authorities; conduct training visits and mentor site staff on protocol requirements, GCP, data entry and regulations.
• Engage in remote monitoring per plans and timelines; interface with Medical Affairs, Sales and administrative staff as needed; comply with Teleflex Travel Policy; submit accurate expense reports.
• Provide input to Medical Affairs, Sales and Administrative departments; manage eCRF completion and data query resolution within study guidelines.
• Participate in study team activities and assist with development of conference calls, FAQs and study documents.

CULTURE : Customer Experience – Representing Teleflex in a customer facing position is a tremendous responsibility and opportunity. All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics in order to strengthen the Teleflex brand and relationship with our customers. Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus. Culture and Values – Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data.

EDUCATION / EXPERIENCE REQUIREMENTS :

Bachelor’s or higher-level degree in life sciences, nursing or other health related disciplines or have a comparable qualification. Knowledge of the medical device sector. A minimum of 5 years’ on-site monitoring research experience as a CRA in the medical device or pharmaceutical industry or with a CRO. High level of attention to detail and strong organizational ability paired with excellent people skills. Excellent clinical trial monitoring skills. Previous knowledge of Vascular Interventional Cardiology and / or Peripheral Vascular Intervention is an advantage.

SPECIALIZED SKILLS & OTHER REQUIREMENTS :

Strong working knowledge, understanding and ability to apply MDR, ISO 14155 and ICH / GCP guidelines governing clinical trials. Strong compliance focus. Demonstrated aptitude and knowledge in relevant therapeutic areas and ability to learn and integrate new therapeutic areas knowledge. Ability to train and mentor Clinical Studies personnel for remote and on-site monitoring visits. Ability to train on site staff on the protocol, GCPs, data entry and other pertinent regulations. Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands with sites and study teams. High attention to detail and accuracy. Experience working independently in a regional area with remote or minimal supervision. Proficient knowledge of medical terminology. Effective time management and organizational skills. Excellent professional writing and oral communication skills. Excellent interpersonal skills. Experience with spreadsheets, and databases applications (e.g., MS Word and Excel) Ability to work independently within Teleflex systems. Ability to work independently and as a part of a team. Responsible for adequate and reasonable home office setting including dedicated desk space to accommodate work responsibilities and Teleflex supplied equipment. Fluent (written and spoken) in Italian. Fluent (written and spoken) in English. If necessary, international travel.

TRAVEL REQUIRED : Up to 70%.

POSITION SUMMARY

The Senior Clinical Research Associate (Senior CRA) is responsible for scheduling and conducting on-site and remote monitoring visits in compliance with applicable regulatory standards (MDR, ISO 14155, ICH / GCP guidelines, Teleflex procedures and IRB / EC policies and procedures). The Senior CRA conducts monitoring visits as identified by the monitoring plan, study team or department needs to evaluate data accuracy and subject safety required by review of regulatory documents, medical records, reported data and device storage, if applicable. The Senior CRA must be able to identify issues, present findings to the site staff, provide retraining if needed, provide problem solving strategies and communicate findings to the study team and department management via escalation of issues and / or within the monitoring visit report. The Senior CRA has a minimum of 5 years of work experience as a clinical trial monitor. The Senior CRA assists the Management Team with training needs as well as developing and providing input on monitoring tools and procedures.

CULTURE :

Customer Experience – Representing Teleflex in a customer facing position is a tremendous responsibility and opportunity.

All CMA colleagues are expected to perform with the highest levels of professionalism, service, and ethics in order to strengthen the Teleflex brand and relationship with our customers.

Continuous Improvement - Demonstrates initiative and critical thinking to identify and prioritize process and performance gaps. Develops solutions to deliver improving results. Exemplifies continuous improvement of thought processes and focus.

Culture and Values – Exemplifies Teleflex values and ensures a fair, open, and productive climate that is engaging, ethical, and legally compliant. Strives to work effectively across boundaries in a complex matrix environment. Lead and participate in the process of promotional and other materials, working internally and cross-functionally to ensure materials are processed completely, based on accurate interpretation of clinical practice and data.

• Conducts monitoring within timelines and according to the monitoring plan and Teleflex procedures.
• Works cooperatively with Research Coordinators and Investigators to schedule and conduct monitoring visits incl. site qualification, site initiation, routine monitoring and site closure visits.
• Evaluate quality and integrity of site practices while escalating quality issues as appropriate.
• Works cooperatively with the Teleflex Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits and proactively provides input on site performance.
• Adequately prepares for monitoring visits to ensure monitoring activities are organized, well planned, efficient and thorough. Prepares site email 1-2 weeks prior to on-site and remote monitoring visits. Re-evaluates time necessary for on-site visits. Maximizes time on-site through visit preparation.
• Conducts monitoring visits per the department SOP, WIs and monitoring plans. Applies MDR, ISO 14155, ICH / GCP guidelines and Teleflex SOP and WIs to monitoring activities.
• Completes the Investigator Files with all appropriate documentation. Ensures all required documentation is completed prior to site initiation, during enrolment and follow-up, and at site close out.
• Presents findings to site staff. Provides clear directions for resolution. Provides appropriate retraining. Reviews data queries with site staff to ensure they are understood and can be resolved.
• Serves as a resource to clinical site staff between visits to provide clarification and insights regarding data queries, action items and visit preparation.
• Completes professional, accurate and succinct Monitoring Visit Reports (MVRs) and Monitoring Visit Follow-up Letters per Teleflex procedures.
• Professionally documents monitoring visit action items. Action items will clearly identify the issue and suggest accurate instructions for resolution.
• Collect necessary documents and contribute to document filing.
• Ensures compliance with national and local safety reporting requirements.
• Collect information of local safety reporting requirements and report to Saftey Officer (SO) at pre-defined timepoints
• Prepare national safety related submission documents to EC / NCA upon request by SO
• Be contact for national EC(s) and NCA regarding safety reporting upon request by SO
• Submission of local safety documentation to EC / NCA upon request by SO
• Follow up with study sites of Safety / Adverse event related tasks upon request by SO
• Ensuring that national / local requirements are met in respect to safety-related documents used and in respect to safety event reporting processes
• Collect local data protection requirement information and report to CPM prior to study start
• Assists the Clinical Project Manager in the department and in study related projects as requested including in-house audits, investigator meetings, training, etc.
• Conducts co-monitoring with Clinical Studies personnel to confirm monitoring is conducted consistently with the protocol, department SOP, WIs and monitoring plans and regulatory standards.
• Oversee training of newly hired Clinical Studies personnel. Provide leadership to the RCRA Group performing day-to-day responsibilities for clinical studies.
• Support in adapting the applicable WIs and Guidelines in accordance to necessary regulations.
• Preparation and support during safety inspections and audits by regulatory authorities.
• Conducts training visits with Clinical Studies personnel to train and mentor individuals on conducting monitoring consistent with the protocol, department SOP, WIs and monitoring plans and regulatory standards.
• Provide training of site to protocol requirements. Develop and oversee training for general research and site management. May conduct ongoing general training calls with site staff per study needs.
• Performs remote per monitoring plans and department needs within the established timelines and follows queries to resolution.
• Interfaces with Medical Affairs, Sales and administrative staff as necessary to accomplish the above responsibilities.
• Complies with the Teleflex Travel Policy. Completes and submits accurate expense reports.
• Provides input to Medical Affairs, Sales and Administrative Departments as necessary to accomplish the above responsibilities.
• Manage and assist eCRF completion, data query resolution within study guidelines.
• Participate in the study team and assist on development of conference calls with site staff, FAQs, and other study documents.

• Bachelor’s or higher-level degree in life sciences, nursing or other health related disciplines or have a comparable qualification.
• Knowledge of the medical device sector.
• A minimum of 5 years’ on-site monitoring research experience as a CRA in the medical device or pharmaceutical industry or with a CRO.
• High level of attention to detail and strong organizational ability paired with excellent people skills.
• Excellent clinical trial monitoring skills.
• Previous knowledge of Vascular Interventional Cardiology and / or Peripheral Vascular Intervention is an advantage.

• Strong working knowledge, understanding and ability to apply MDR, ISO 14155 and ICH / GCP guidelines governing clinical trials. Strong compliance focus.
• Demonstrated aptitude and knowledge in relevant therapeutic areas and ability to learn and integrate new therapeutic areas knowledge.
• Ability to train and mentor Clinical Studies personnel for remote and on-site monitoring visits.
• Ability to train on site staff on the protocol, GCPs, data entry and other pertinent regulations.
• Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands with sites and study teams.
• High attention to detail and accuracy.
• Experience working independently in a regional area with remote or minimal supervision.
• Proficient knowledge of medical terminology.
• Effective time management and organizational skills.
• Excellent professional writing and oral communication skills.
• Excellent interpersonal skills.
• Experience with spreadsheets, and databases applications (e.g., MS Word and Excel)
• Ability to work independently within Teleflex systems.
• Ability to work independently and as a part of a team.
• Responsible for adequate and reasonable home office setting including dedicated desk space to accommodate work responsibilities and Teleflex supplied equipment.
• Fluent (written and spoken) in Italian.
• Fluent (written and spoken) in English.
• If necessary, international travel.

TRAVEL REQUIRED : Up to 70%.