Lavori attuali relativi a Cra - Italy - Roma - Linical Europe
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Sr. Clinical Research Associate
3 mesi fa
Roma, Italia Cmed A tempo pienoThe Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Czech Republic, Switzerland, Denmark, Romania, and India. The CRO occupies a unique position in the clinical...
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Clinical Research Associate 1
3 mesi fa
Roma, Italia Novo Nordisk A tempo pienoDo you want to join one of the leading companies of the pharma sector? Do you want to build your career and contribute to the growth of the company? If it sounds interesting to you, we have the right job! The Italian affiliate of Novo Nordisk, based in Rome, is hiring a Clinical Research Associate (CRA) 1. You will join our Clinical Operations Team and...
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Clinical Research Associate
4 mesi fa
Roma, Italia MSD A tempo pienoThe role of Clinical Research Associate is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting requirements...
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Clinical Research Associate Ii
3 mesi fa
Roma, Italia Sitero LLC A tempo pienoSitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our...
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Snr Cra
4 mesi fa
Roma, Italia Worldwide Clinical Trials A tempo pieno**Requisition Number** **6848** **Employment Type***: **Contractor** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...
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Medical Advisor
3 mesi fa
Roma, Italia ICON plc A tempo pienoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
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Clinical Research Associate
3 settimane fa
Roma, Italia TFS HealthScience A tempo pieno**CRA Italy - 0.2/0.4 FTE - FREELANCE** **About this role** TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP)...
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Clinical Research Associate I
4 mesi fa
Roma, Italia Ora A tempo pieno**POSITION TITLE**: Clinical Research Associate I **DEPARTMENT **:Ora Europe **LOCATION**: Italy **_ Ora Values the Daily Practice of_** - Prioritizing Kindness - Operational Excellence - Cultivating Joy - Scientific Rigor_ - _______________________________________ **The Role**: Ora's Clinical Research Associate I (CRA I) develops strong clinical site...
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Clinical Operations Manager Lead
2 mesi fa
Roma, Italia MSD A tempo pienoJob DescriptionThis role is accountable for the execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our Company policies and procedures and with quality standards, both internally and externally.The person has ownership, oversight, and impact on local financial compliance and on...
Cra - Italy
4 mesi fa
Linical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With more than 700 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.
Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central
- and Eastern Europe.
**Role summary**:
- balance, performing a lower number of site visits.
You can work fully home
- based from any Italian city.
**Responsibilities**:
- Ensure that the conduct of the study is in compliance with the currently approved study protocol/amendment(s), with ICH GCP, SOPs, and any applicable regulatory requirements in the assigned countries
- Conduct any kind of on-site monitoring visits (pre-study, initiation, routine monitoring, site closure)
- Review of and/or input to the study protocol, CRF and validation tools
- Preparation and/or review of Monitoring Guidelines, CRF Completion Guideline, patient information documents
- Preparation of submissions to Independent Ethics Committees (central and local) and to Competent Authorities
- Assisting of Investigator and Institution contracts, negotiating budgets and arranging site payments
- Query management in cooperation with the Clinical Data Management Team
- Assisting sites and the study team in managing contacts to external service providers such as central laboratories
- Participation in feasibility studies and Investigator selection
- Responsibility for Site Management
**Experience & Qualifications**:
- University degree in sciences or related fields, as well as experience & knowledge of clinical trials and regulations
- Advanced English & fluent Italian
- At least 1 year of experience within Clinical Monitoring in a pharmaceutical company or a CRO
- Sound knowledge of relevant guidelines (e.g. ICH GCP) and regulatory requirements
- Travel availability across Italy
