Clinical Research Associate, Italy
8 mesi fa
**Job summary**:
As a **Clinical Research Associate **you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties. You will function as the primary contact for sites regarding regulatory compliance and protocol questions and communicate with clinical sites on an ongoing basis to address and resolve issues. Reporting to **Clinical Operations Manager**, you will be a key member of the Clinical Operations team in Italy.
We are searching for ambitious and energetic person, able to undertake challenges in the project, push forward development of the project and function well in the project team. The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.
**Main Tasks of the Position**:
- Responsible for recruitment of potential investigators, involvement in CA and EC submissions and notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
- Responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits and close out visits, assists on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties
- Functions as the primary contact for sites regarding regulatory compliance and protocol questions and communicates with clinical sites on an ongoing basis to address and resolve issues;
- Assists in Business Development activities
- May have supervisory functions in clinical projects
- May be required to train, coach and supervise junior staff
**Required Qualifications, Experience, Competencies**
- Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/ guidelines
- Excellent organizational and time management skills
- Skills to handle multiple priorities and to work with deadlines and under pressure
- Excellent written and oral communication skills
- Skills to coach and mentor other clinical staff
- Fluent in written and verbal English and Italian
- Computer skill
**Benefits**:
- Working with experienced and very professional and supportive team
- Possibility to grow within the Company
- Competitive remuneration
- Flexible working time
- Eligibility to the Company Bonus scheme
- Homebased/Office based
-
Clinical Research Associate Opportunity in Italy
4 settimane fa
Roma, Lazio, Italia Rbw Consulting Llp A tempo pienoRbw Consulting Llp is seeking a Freelance Clinical Research Associate to monitor two sites in Italy for an ongoing medical device study. The ideal candidate will have experience in clinical research, preferably with medical devices, and a strong understanding of GCP and regulatory guidelines. The role involves conducting site visits, ensuring compliance with...
-
Clinical Research Associate
4 settimane fa
Roma, Lazio, Italia Pharmiweb A tempo pienoJob Title: Clinical Research Associate - Freelance OpportunityJob Description:We are seeking a non-certified Freelance Clinical Research Associate to monitor two sites in Italy for an ongoing medical device study. Due to this being a Medical Device project, certification is not required.Your Role:Conduct site visits, including initiation, monitoring, and...
-
Associate Clinical Research Associate
6 mesi fa
Roma, Italia MSD A tempo pienoThe role of **Associate Clinical Research Associate** support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations,...
-
Freelance Clinical Research Associate
1 mese fa
Roma, Lazio, Italia Rbw Consulting Llp A tempo pienoFreelance CRA Opportunity in ItalyRbw Consulting Llp are partnered with a small European CRO seeking a non-certified Freelance Clinical Research Associate to monitor two sites in Rome for an ongoing medical device study.Due to this being a Medical Device project, you do not need to be certifiedYour Role:Conduct site visits, including initiation, monitoring,...
-
Sr. Clinical Research Associate
5 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...
-
Clinical Research Associate
3 mesi 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)...
-
Clinical Research Associate
6 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...
-
Lead Clinical Research Associate
3 settimane fa
Roma, Italia Ora A tempo pieno**POSITION TITLE**: Lead Clinical Research Associate **DEPARTMENT**: Ora Europe **LOCATIONS**:Poland, Spain or Italy **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...
-
Lead Clinical Research Associate
4 ore fa
Roma, Italia Ora A tempo pieno**POSITION TITLE**: Lead Clinical Research Associate **DEPARTMENT**: Ora Europe **LOCATIONS**:Remote, Italy **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...
-
Associate Clinical Research Associate
2 mesi fa
Roma, Italia MSD A tempo pieno**Secondary** Language(s) Job Description**: We are looking for an **Ass. Clinical Research Associate** to join our Clinical Research Monitor Team. With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. **Responsibilities...
-
Clinical Research Associate Director
4 settimane fa
Roma, Lazio, Italia Msd A tempo pienoJob SummaryWe are seeking a highly skilled Associate Director to join our Clinical Research team at MSD. This role will be responsible for managing a team of Clinical Research Associates (CRAs) and ensuring excellent study and site performance.Key ResponsibilitiesManage a team of 6-14 CRAs and ensure strict adherence to local regulations, company SOPs, and...
-
Clinical Research Associate
2 settimane 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...
-
Clinical Research Associate
4 settimane fa
Roma, Lazio, Italia Rbw Consulting Llp A tempo pienoRbw Consulting Llp is seeking a Freelance Clinical Research Associate to monitor two sites in Italy for an ongoing medical device study. This is a non-certified opportunity, making it ideal for those new to the field or looking to gain experience in medical device research. Your role will involve conducting site visits, ensuring compliance with study...
-
Clinical Research Associate
5 mesi fa
Roma, Italia Meditrial Europe Ltd. A tempo pienoMeditrial is a full-service digital research organization with a foundation in clinical trial research, education, regulatory and market access. Meditrial has been leading the medical tech industry by delivering unparalleled outcomes for innovators. Our successful track record supporting medical device and biotechnology companies in all phases of clinical...
-
Lead Clinical Research Associate
1 settimana fa
Roma, Italia Ora A tempo pienoPOSITION TITLE: Lead Clinical Research Associate DEPARTMENT: Ora Europe LOCATIONS: Poland, Spain or Italy 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...
-
Clinical Research Associate
5 mesi fa
Roma, Italia MSD A tempo pieno**Job Description**: The role 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, policies and procedures, quality standards and adverse event reporting requirements internally and...
-
Clinical Research Attorney
2 settimane fa
Roma, Lazio, Italia AbbVie A tempo pienoAt AbbVie, we seek a seasoned attorney to collaborate with our global R&D organization, providing strategic legal and business guidance.The ideal candidate will be responsible for identifying and resolving complex legal issues, drafting and negotiating agreements, and working with internal stakeholders and third-party partners.Drafting, reviewing, and...
-
Medical Device Contract Research Associate
2 settimane fa
Roma, Lazio, Italia Pharmiweb A tempo pieno**Opportunity for Freelance CRAs in Italy**Pharmiweb is looking for a dedicated Freelance Clinical Research Associate to join our dynamic team in Italy. As a Freelance CRA, you will play a key role in monitoring clinical trials for medical devices.**Key Responsibilities:**Monitor clinical trials for medical devicesStrong organizational and communication...
-
Lead Clinical Research Coordinator
2 settimane fa
Roma, Lazio, Italia Ora A tempo pienoAbout Ora:Ora is a leading full-service ophthalmic drug and device development firm.Job Title: Lead Clinical Research AssociateLocation: Poland, Spain, or ItalyJob Summary:As a Lead Clinical Research Associate at Ora, you will be responsible for developing strong clinical site relationships and ensuring compliance with study conduct.Key Responsibilities:•...
-
Clinical Research Associate Ii
6 mesi fa
Roma, Italia ABBVIE A tempo pieno**Key responsibilities**: - Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring...