Experienced Clinical Research Associate

1 settimana fa

Milano, Italia Novasyte A tempo pieno

Senior Clinical Research Associate, Italy

Job overview:
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

**Qualifications**:

- University Bachelor's Degree and Master's Degree in scientific discipline or health care
- In possess of CRA Certification as required by Ministerial Decree dated 15.11.2011
- Requires at least 2 years of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
- Written and verbal communication skills including good command of English language and fluent Croatian.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

  • Clinical Research Associate

    1 mese fa

    Milano, Italia Ab Lavoro A tempo pieno

    Descrizione azienda Siamo una società di consulenza, specializzata nella ricerca e selezione del personale, autorizzata dal Ministero ad operare come Agenzia per il Lavoro (Aut. Min. Lav. n. 13/I/5640), su tutto il territorio nazionale. Che tu voglia inserirti nel mondo del lavoro, o sia alla ricerca di nuovi stimoli professionali, AB Lavoro è pronta a...

  • Clinical Research Associate

    3 settimane fa

    Milano, Italia Ab Lavoro A tempo pieno

    Descrizione azienda Siamo una società di consulenza, specializzata nella ricerca e selezione del personale, autorizzata dal Ministero ad operare come Agenzia per il Lavoro (Aut. Min. Lav. n. 13/I/5640), su tutto il territorio nazionale. Che tu voglia inserirti nel mondo del lavoro, o sia alla ricerca di nuovi stimoli professionali, AB Lavoro è pronta a...

  • Clinical Research Associate Certificati

    1 settimana fa

    Milano, Lombardia, Italia Confidenziale A tempo pieno

    Clinical Research Associate certificati (CRA I, CRA II, Senior CRA I) o prossimi alla certificazione MilanoPer l italiana (provincia di Milano) di unimportante CRO, ricerchiamo le seguenti figure professionali:Junior CRA;- Clinical Research Associate I (CRA I);- Clinical Research Associate II (CRA II);- Senior Clinical Research Associate I (sCRA I).Per tutte...

  • Experienced Clinical Research Associate

    3 settimane fa

    Milano, Italia Medpace, Inc. A tempo pieno

    Job Summary: 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...

  • Clinical Research Associate

    3 settimane fa

    Milano, Italia Boston Scientific Corporation A tempo pieno

    **Clinical Research Associate**: - Remote Eligible: Remote in Country- Onsite Location(s): Milan, MI, IT**Additional Locations**: Italy-Milan; Italy-Rome **About The Role**: The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO’s mission of building a world...

  • In House Clinical Research Associate

    4 settimane fa

    Milano, Italia Fortrea A tempo pieno

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Research Associate

    1 settimana fa

    Milano, Lombardia, Italia Pharmiweb A tempo pieno

    The Clinical Research Associate position at Medpace offers an opportunity for a fulfilling career in drug and medical device development, where you can have a positive impact on the lives of others. If you come from a medical or life science background and are interested in entering the research field to contribute to bringing pharmaceuticals and medical...

  • In House Clinical Research Associate

    1 settimana fa

    Milano, Lombardia, Italia Fortrea A tempo pieno

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Research Associate

    1 settimana fa

    Milano, Lombardia, Italia Amaris Consulting A tempo pieno

    Job description Amaris Consulting is a leading global pharmaceutical and clinical research organization dedicated to advancing healthcare through innovative research and development. Our team is composed of passionate professionals committed to improving patient outcomes and advancing medical science. Position Overview: We are seeking an experienced...

  • Snr Clinical Research Associate

    1 settimana fa

    Milano, Lombardia, Italia Worldwide Clinical Trials A tempo pieno

    Requisition Number6939Employment Type:ContractorWho we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage, our...

  • Clinical Research Associate

    2 settimane fa

    Milano, Italia Excelya A tempo pieno

    Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas. We take a one-team approach to work: our shared success is the result of collaboration at every stage of a...

  • Junior Clinical Research Associate

    2 mesi fa

    Milano, Italia Novasyte A tempo pieno

    Experienced Clinical Research Associate, Ital Your responsibilities will include: - Performing site selection, initiation, monitoring and close-out visits - Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and International Conference on Harmonization guidelines - Managing...

  • Junior Clinical Research Associate

    2 giorni fa

    Milano, Italia Novasyte A tempo pieno

    Experienced Clinical Research Associate, Ital Your responsibilities will include: - Performing site selection, initiation, monitoring and close-out visits - Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice and International Conference on Harmonization guidelines - Managing...

  • Clinical Research Associate Cochlear

    1 settimana fa

    Milano, Lombardia, Italia TFS HealthScience A tempo pieno

    Overview:CRA ITALY - SINGLE SPONSOR - GLOBAL MEDICAL DEVICE COMPANY -SITES: PADOVA, PIACENZA, BARITFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated Clinical Research Associate (CRA) in Italy who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced...

  • Clinical Research Associate Ii

    1 mese fa

    Milano, Italia Psi Cro A tempo pieno

    PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description As a  Clinical Research Associate  at PSI Italy you will enjoy...

  • Clinical Research Associate Ii

    3 settimane fa

    Milano, Italia Psi Cro A tempo pieno

    PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description As a  Clinical Research Associate  at PSI Italy you will enjoy...

  • Clinical Research Associate Cochlear

    2 mesi fa

    Milano, Italia TFS HealthScience A tempo pieno

    Overview: **CRA ITALY - SINGLE SPONSOR - GLOBAL MEDICAL DEVICE COMPANY - SITES: PADOVA, PIACENZA, BARI** TFS HealthScience is excited to be expanding our SRS ** **team and we are looking for an experienced, highly motivated Clinical Research Associate (CRA) in Italy who shares our vision of providing clinical research excellence. Our SRS team is a highly...

  • Clinical Research Associate Cochlear

    3 settimane fa

    Milano, Italia TFS HealthScience A tempo pieno

    Overview: **CRA ITALY - SINGLE SPONSOR - GLOBAL MEDICAL DEVICE COMPANY - SITES: PADOVA, PIACENZA, BARI** TFS HealthScience is excited to be expanding our SRS ** **team and we are looking for an experienced, highly motivated Clinical Research Associate (CRA) in Italy who shares our vision of providing clinical research excellence. Our SRS team is a highly...

  • Clinical Research Associate Ii

    3 settimane fa

    Milano, Italia Clinchoice A tempo pieno

    Clinical Research Associate II (CRA II) or Senior Clinical Research Associate (SCRA) at ClinChoice (View all jobs) Italy ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our...

  • Clinical Research Associate Ii

    3 settimane fa

    Milano, Italia Ora A tempo pieno

    **POSITION TITLE**: Clinical Research Associate II **DEPARTMENT**:Ora Europe **LOCATION**: Remote, Italy or Spain **Ora Values the Daily Practice of ** - Prioritizing Kindness - Operational Excellence - Cultivating Joy - Scientific Rigor_ - _At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic...