Clinical Research Associate
3 mesi fa
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary
**Job Description**:
ROLE
The CRA is an important member of the Alira Health Clinical team. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.
KEY RESPONSABILITIES
The Resource will support the team in Italy and they:
- Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.-
- Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed.-
- Ensures appropriate and timely investigator site visits.-
- Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.-
- Assists in development of study-specific Monitoring Plans and training presentations as required.-
- Assists in set up/collection of site specific ethics documents and site contract negotiation as required.-
- Provides monthly billing information to finance team as required.-
- For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.-
- Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits.-
- Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.-
- Ensures integrity of CRF data through meticulous and thorough source document review and verification.-
- Performs quality control and verification of documents collected at sites for eTMF/TMF.-
- Conducts investigational product accountability.-
- Reviews site regulatory binder for required documents.-
- Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.-
- Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.-
- Participates in internal, client/sponsor, scientific, and other meetings as required.-
- Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.-
- Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.-
- Proactively identifies site issues and develops problem-solving strategies for sites.-
- Conducts audit preparation at study sites as needed.-
- Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.-
- Participates in internal, client/sponsor, scientific, and other meetings as required.-
- Assists in CRA new hire training and onboarding.-
- Performs CRA mentoring.-
- Collaborates with development and maintenance of Clinical Trial Management System (CTMS).-
- Manages and resolves conflicting priorities to deliver on commitments.-
- Performs additional duties as assigned.DESIRED QUALIFICATION & EXPERIENCE- EU: Graduation in a scientific health field-
- EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011-
- Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members-
- Ability to autonomously manage monitoring activities-
- At least 3-4 years of the experience as CRA-
- The Resource needs to live in Italy-
- Experience in Oncology, preferredTECHNICAL COMPETENCES & SOFT SKILLS- Quality focused; Proven ability to be careful, thorough, and detail-oriented- Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment- Able to manage priorities, organize time and solve problems- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills- Ability to travel- Ability to manage stress- Professional, trustworthy and disciplined- Ability to problem-solve unstructured or ambiguous challenges- Strong command of Local language, both written and verbal, in the country where monitoring activities are performed- Excellent communication and interpersonal skills with customer service orientation- Good computer skills, with ability to use clinical trial management systems, clinical trial databases and
-
Clinical Research Associate
3 mesi fa
Verona, Italia Alira Health A tempo pienoJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...
-
Research Expert Veterinarian
3 mesi fa
Verona, Italia Evotec A tempo pienoEvotec Company is a worldwide Pharmaceutical Organization, collaborating with all the major Pharma and Biotech companies in support of various drug discovery and development projects. To efficiently support current activities and needs, we are looking for a Research Expert Veterinarian to join our team in Verona. REQUIRED SKILLS - post-degree specialization...
-
Clinical Operations Manager
1 settimana fa
Verona, Veneto, Italia GlaxoSmithKline A tempo pienoJob Title: Clinical Operations ManagerGlaxoSmithKline is seeking a highly skilled Clinical Operations Manager to lead our local study team in Italy - Verona. As a key member of our clinical development team, you will be responsible for managing the activities of within-country operational planning and delivery of Phase I-IV clinical trials.Key...
-
Clinical Trials Operations Lead
1 settimana fa
Verona, Veneto, Italia Glaxosmithkline A tempo pienoJob SummaryGlaxoSmithKline is seeking a highly skilled Clinical Trials Operations Lead to join our team. As a key member of our clinical operations team, you will be responsible for leading the local study team and ensuring the successful delivery of clinical trials in a specific country.Key Responsibilities:Lead the local study team, providing matrix...
-
Clinical Project Manager
4 mesi fa
Verona, Italia ClinChoice A tempo pienoAre you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice, is searching for a Clinical Project Manager to join an international pharmaceutical company, with a focus on Respiratory, Paediatrics, Rare...
-
Trainee Gmp Clinical Manufacturing
4 mesi fa
Verona, Italia Evotec A tempo pienoAptuit, an Evotec company, is a worldwide Contract Research Organization, collaborating with all the major Pharma and Biotech companies in support of various drug discovery and development projects, from early to late phases. We are currently looking for a Trainee for a 6 months internship in Clinical GMP Manufacturing department to learn and support the...
-
Clinical Trial Assistant
4 mesi fa
Verona, Italia ClinChoice A tempo pienoAre you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice, is searching for a Clinical Trial Assistant to join an international pharmaceutical company, with a focus on Respiratory, Paediatrics, Rare...
-
Lead Data Manager
3 mesi fa
Verona, Italia Alira Health A tempo pienoJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...
-
Associate Scientist
3 mesi fa
Verona, Italia Evotec A tempo pienoEvotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of...
-
Local Delivery Lead
2 settimane fa
Verona, Italia Glaxosmithkline A tempo pienoSite Name: Italy - VeronaPosted Date: Sep 10 2024The LDL provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country, across all therapy areas (Pharma and Vx) to the required quality standards, GSK written standards, local regulations and ICH GCP.Job purpose...
-
Local Delivery Lead
2 settimane fa
Verona, Italia Glaxosmithkline A tempo pienoSite Name: Italy - VeronaPosted Date: Sep 10 2024The LDL provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country, across all therapy areas (Pharma and Vx) to the required quality standards, GSK written standards, local regulations and ICH GCP.Job purpose...
-
Local Delivery Lead
2 settimane fa
Verona, Italia GSK A tempo pieno**Site Name**: Italy - Verona **Posted Date**: Sep 10 2024 The LDL provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country, across all therapy areas (Pharma and Vx) to the required quality standards, GSK written standards, local regulations and ICH...
-
Statistical Consultant
4 mesi fa
Verona, Italia Alira Health A tempo pienoJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...
-
Verona, Italia W. L. Gore & Associates A tempo pienoJob: Clinical/Regulatory Primary Location: Europe-IT-34-Verona Other Locations: Europe-ES-CT-Barcelona Travel%: 60% Shift: Day Schedule: Full-time **Provider Health Economic and Value Strategist (f/m/d) - Home Office**-231435 **About Us**:Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding...
-
Verona, Italia W. L. Gore & Associates A tempo pieno**About Us**:Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates. We are looking for a Provider Health Economic (HE) (f/m/d) and Value Strategist (f/m/d) who will collaborate with the Country Value Strategist, Health Economics & Outcome Research, Provider selling (PST)...
-
Proposal & Contract Analyst
5 giorni fa
Verona, Italia Alira Health A tempo pienoJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...
-
Principal Project Manager, Biometrics
3 mesi fa
Verona, Italia Alira Health A tempo pienoJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...
-
Informatore Scientifico del Farmaco
4 mesi fa
Verona, Italia IQVIA A tempo pienoPer conto di un’importante realtà multinazionale leader nel settore farmaceutico, stiamo ricercando un Informatore Scientifico del Farmaco per la zona di Verona. Il profilo inserito, riportando direttamente all’Area Manager di riferimento, sarà responsabile della presentazione dei farmaci dell’azienda cliente presso specialisti in ambito...
-
Lab Technician
4 mesi fa
Verona, Italia Ecolab A tempo pienoEcolab is seeking a **Lab Technician** **in Settimo di Pescantina (Verona)** who will be responsible for analytical testing that will be used in the development of new product specifications. In this position you will perform quality testing, maintenance, and calibrations of the instruments in addition to assisting in the development of new test methods as...
-
Account Manager
4 mesi fa
Verona, Italia Thermo Fisher Scientific A tempo pieno**About Us**: - Here at Thermo Fisher Scientific, our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research, clinical to commercial production means you can have a broad and significant impact. All while working in an environment where you will be supported, valued...