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 drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past forty years, our expert teams have helped earn more than fifty new product approvals. Today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia.

**The Role**:
Ora's Clinical Research Associate II (CRA II) develops strong clinical site relationships and is accountable for performance and compliance with assigned protocols at our sites. Our CRA II's will work with the oversight of the Lead CRA's and Line Manager. As a CRA II, you will ensure Ora's compliance of study conduct by monitoring the site activities with ICH/GCP and country regulations, Ora's policies, and Sponsor SOPs by partnering cross-functionally within Ora.

**What You'll Do**:

- Clear and sustained demonstration of the Ora Clinical's Values of prioritizing kindness, operational excellence, cultivating joy and scientific rigor.
- Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs, with oversight, clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gain in-depth understanding of the study protocol and related procedures.
- Coordinate & manage various tasks in collaboration with other internal roles to achieve Site Readiness.
- Participate & provide input on site selection and validation activities.
- Perform remote and on-site monitoring & oversight activities using various tools to ensure:

- Data generated at site are complete, accurate and unbiased.
- Subjects' right, safety and well-being are protected.
- Conducts site visits including but not limited to evaluation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identify, assess and resolve site performance, quality or compliance problems and escalates as appropriate in collaboration with Clinical Research Lead and CRA line manager.
- Manage and maintain information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Supports audit/inspection activities as needed.
- Travel Requirements up to 75%.
- Responsibilities may differ slightly from the above based on specific needs of the business.

**What We Look For**:

- _Experience needed for the Role: _
- Bachelor's degree with 2 years' experience as a Clinical Research Associate or equivalent combination of education, training, and experience. Years of experience may be considered in lieu of education.
- _Additional Skills & Attributes:_
- Ophthalmic experience is strongly preferred.
- Capacity to routinely assess protocol and GCP compliance.
- Demonstrated ability to verify source data to reported data.
- Strong attention to detail to review the completeness of the investigator site file. Knowledge to reconcile and return/destroy test articles while conducting initiation, interim, and close-out visits.
- Knowledge of the federal regulations governing research and the standards defining Good Clinical Practices (GCPs).
- Ability to read and demonstrate comprehension of a clinical research protocol as well as understand the importance of following the protocol.
- Proficiency with Excel, CTMS, and EDC.
- Multilingual communication is a plus.
- _Competencies and Personal Traits:_
- **Attention to Detail**: Ability to analyze data to drive successful solutions to complex problems.
- **Emotionally Intelligent Leadership**: Ability to lead with a positive mindset and empathy.
- **Intellectual **Curiosity**: Willingness and desire to learn new things and dig deeper than the surface.
- **Innovative Mindset**: Forward thinking, creative and open to testing, making mistakes and trying again.
- **Organization and Goal Setting**:Ability to set goals, develop structure and maintain a focused approach to critical path work.
- **Resolve Conflicts**:Practice radical candor in your communication and participate in active listening to help the other person feel heard and understood.
- **

  • Clinical Research Associate Certificati

    5 giorni 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...

  • 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 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

    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 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...

  • 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...

  • In House Clinical Research Associate

    5 giorni 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

    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...

  • Snr Clinical Research Associate

    5 giorni 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 Ii

    3 settimane fa

    Milano, Italia Labcorp A tempo pieno

    **Clinical Research Associate 2 / CRA 2 - Clinical Operations Team** Location: Italy A formula for clinical innovation: Labcorp Drug Development. With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas - improving...

  • Clinical Research Associate Ii

    4 settimane fa

    Milano, Italia Clinchoice A tempo pieno

    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 in-house team as a Clinical Research Associate (CRA II or Senior CRA) on a permanent basis. You will be responsible for site...

  • Clinical Research Associate Ii

    3 settimane fa

    Milano, Italia Clinchoice A tempo pieno

    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 in-house team as a Clinical Research Associate (CRA II or Senior CRA) on a permanent basis. You will be responsible for site...

  • Clinical Research Associate

    5 giorni 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...

  • Clinical Research Associate

    5 giorni 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...

  • Clinical Research Associate Ii

    5 giorni 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 II

    5 giorni fa

    Milano, Lombardia, Italia Allucent A tempo pieno

    At AllucentTM, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Research Associate II (CRAII) to join our A-team (hybrid*/remote). As a CRAII at Allucent, you will independently...

  • Clinical Research Associate

    3 settimane fa

    Milano, Italia ICON A tempo pieno

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

  • Clinical Research Associate

    3 settimane fa

    Milano, Italia ICON plc A tempo pieno

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...