Clinical Research Associate
5 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 Assistant Internship
2 settimane fa
Verona, Veneto, Italia Alira Health A tempo pienoJob DescriptionWe are seeking a Clinical Trial Coordinator Intern to assist our clinical research team in conducting studies according to GCP, SOP, protocol, and respecting budget and timelines.Key Responsibilities:Assist with start-up activities, including ethical and regulatory submissions, and sites contracts negotiation.Prepare and maintain ISF documents...
-
Clinical Research Associate
5 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...
-
Clinical Project Manager
4 settimane 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...
-
Clinical Project Manager
3 settimane 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...
-
Clinical Project Manager
3 settimane 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 Summary...
-
Clinical Project Manager
3 settimane 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 Summary...
-
Clinical Project Manager
2 settimane 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...
-
Clinical Trial Coordinator Internship
2 settimane fa
Verona, Veneto, Italia Alira Health A tempo pienoJob SummaryA Clinical Trial Coordinator Intern assists the clinical research team in ensuring the conduct of studies in accordance with GCP, SOP, protocol, and budget and timelines. The role is responsible for start-up activities and document management.Key ResponsibilitiesResponsible for start-up activities, including Ethic and Regulatory submission, and...
-
Research Expert Veterinarian
5 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 Trial Coordinator Internship
4 settimane 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...
-
Clinical Trial Coordinator Internship
3 settimane 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...
-
Clinical Trial Coordinator Internship
3 settimane 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 Summary...
-
Clinical Trial Coordinator Internship
4 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 Summary ...
-
Clinical Trial Coordinator Internship Specialist
3 settimane fa
Verona, Veneto, Italia Alira Health A tempo pienoRole Summary: We are seeking a highly motivated Clinical Trial Coordinator Intern to support our dynamic global team in delivering innovative solutions. As part of our team, you will be responsible for assisting in the planning, execution, and monitoring of clinical trials, ensuring adherence to Good Clinical Practice (GCP) and regulatory requirements.Key...
-
Medical Research Coordinator Intern
3 giorni fa
Verona, Veneto, Italia Alira Health A tempo pienoAt Alira Health, we are dedicated to innovation and excellence in clinical research. We offer a dynamic and collaborative environment where our team members can grow and develop their skills.Job OverviewThis internship is an excellent opportunity for students and recent graduates to gain hands-on experience in medical research coordination.ResponsibilitiesWe...
-
Clinical Trial Coordinator Internship
7 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...
-
Clinical Project Manager
5 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...
-
Clinical Operations Internship: Stage per Tesi
4 settimane fa
Verona, Veneto, Italia 853 GlaxoSmithKline S.p.A. A tempo pienoParticipate in the development of clinical trials and gain hands-on experience in the field of clinical operations.About the Role:Support the Monitoring and Site Engagement Team in managing clinical trials.Develop skills in ethics and regulatory compliance, as well as technical and operational competencies in clinical research.Collaborate with...
-
Clinical Operations Manager
2 settimane fa
Verona, Veneto, Italia Alira Health A tempo pienoAlira Health OverviewWe are a global healthcare consulting firm dedicated to helping our clients overcome complex challenges and achieve their goals. Our team is passionate about innovation, initiative, and collaboration.About the RoleThe Project Manager (PM) plays a crucial role in the success of our clinical trials. As a PM, you will be responsible for...
-
Trainee Gmp Clinical Manufacturing
5 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...