[Oncology]Clinical Research Associate
hace 1 semana
Typical Accountabilities:Contributes to the selection of potential investigators.In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.Actively participates in Local Study Team (LST) meetings.Contributes to National Investigators meetings, as applicable.Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.Updates CTMS and other systems with data from study sites as per required timelines.Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.Ensures data query resolution in a timely manner.Works with data management to ensure robust quality of the collected study data.Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.Prepares and finalises monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP.Follows up on outstanding actions with study sites to ensure resolution in a timely manner.Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.Assists site in maintaining inspection ready ISF.Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and CQAD.Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).Ensures compliance with local, national and regional legislation, as applicable.Collaborates with local MSLs as directed by LSAD or line manager.Competencies and Skills:Ability to deliver quality according to the requested standards.Ability to work in an environment of remote collaborators.Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.Good analytical and problem solving skills.Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.Good cultural awareness.Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
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Clinical Research Associate
hace 6 meses
España MRL Consulting Group A tiempo completo**Senior Clinical Research Associate** **About Us**: **MRL Consulting Group** is partnered with a leading contract research organization dedicated to advancing the field of oncology research. They are committed to conducting groundbreaking clinical trials that lead to the development of innovative cancer treatments. Our mission is to improve the lives of...
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Clinical Research Physician
hace 2 meses
España Translational Research in Oncology A tiempo completoTranslational Research in Oncology (TRIO) is a global clinical research organization dedicated to advancing clinical cancer research. TRIO is looking for a Clinical Research Physician to join our Medical Monitoring Unit team. Reporting to the Medical Monitoring Unit Manager, this will be a home-based, full-time position in Spain. Main Responsibilities: -...
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Clinical Research Physician
hace 2 semanas
España Translational Research in Oncology A tiempo completoTranslational Research in Oncology (TRIO) is a global clinical research organization dedicated to advancing clinical cancer research.TRIO is looking for a Clinical Research Physician to join our Medical Monitoring Unit team. Reporting to the Medical Monitoring Unit Manager, this will be a home-based, full-time position in Spain.Main...
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Clinical Research Physician
hace 2 semanas
España Translational Research in Oncology A tiempo completoTranslational Research in Oncology (TRIO) is a global clinical research organization dedicated to advancing clinical cancer research.TRIO is looking for a Clinical Research Physician to join our Medical Monitoring Unit team. Reporting to the Medical Monitoring Unit Manager, this will be a home-based, full-time position in Spain. Main...
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Clinical Research Associate
hace 1 semana
España TFS HealthScience A tiempo completoTFS 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) solutions.Join Our Team as a Clinical Research Associate (CRA)About...
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Clinical Research Associate
hace 1 mes
España Tfs Healthscience A tiempo completoTFS 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) solutions. Join Our Team as a Clinical Research Associate (CRA) About...
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Senior Clinical Research Associate
hace 1 mes
España Tfs Healthscience A tiempo completoAbout 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) solutions. The Clinical Research Associate (CRA) is...
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Clinical Research Associate
hace 2 semanas
España Thermo Fisher Scientific A tiempo completoJob Description Clinical Research Associate I/II - Barcelona At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...
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Clinical Research Associate
hace 7 meses
España Avania A tiempo completoAvania Clinical is a leading contract research organization (CRO) that offers exciting career opportunities for professionals in the clinical research industry. With a global footprint, a diverse range of therapeutic areas, and expertise in supporting medical device and MedTech solutions, Avania Clinical provides a dynamic and rewarding work environment that...
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Clinical Trial Associate
hace 4 semanas
España buscojobs España A tiempo completoAt TFS HealthScience, we are dedicated to advancing clinical research through innovative solutions and a commitment to quality. We provide tailored services across the clinical development lifecycle to deliver impactful results for our clients and the healthcare industry.Role Overview :We are looking for a Clinical Trial Associate to support TMF archiving...
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Clinical Trial Associate
hace 1 mes
España Tfs Healthscience A tiempo completoAt TFS HealthScience, we are dedicated to advancing clinical research through innovative solutions and a commitment to quality. We provide tailored services across the clinical development lifecycle to deliver impactful results for our clients and the healthcare industry. Role Overview: We are looking for a Clinical Trial Associate to support TMF archiving...
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Senior Clinical Research Associate
hace 2 semanas
España TFS HealthScience A tiempo completoSenior CRA Madrid - Single sponsor - Recognized Biotech CompanyAbout this roleTFS 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...
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Clinical Research Associate
hace 1 semana
España TFS HealthScience A tiempo completoCRA Madrid - Single sponsor - Recognized Biotech CompanyAbout this roleTFS 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...
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Clinical Research Associate
hace 1 mes
España Tfs Healthscience A tiempo completoCRA Madrid - Single sponsor - Recognized Biotech Company 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...
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Healthcare Research
hace 12 horas
España Clarivate Analytics A tiempo completoHealthcare Research & Data Analyst (Oncology)Apply remote type Hybrid locations Spain - Barcelona time type Full time posted on Posted 3 Days Ago job requisition id JREQ130153We are looking for a Healthcare Researcher & Data Analyst to join our Life Science & Healthcare (Oncology) group in Barcelona.The role comprises three broad functions: 1) market...
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Clinical Research Associate
hace 2 semanas
España Opis S.r.l. A tiempo completoAs a Clinical Research Associate (CRA), you are an essential part of the clinical operations team responsible for coordinating and overseeing the execution of studies and clinical trials according to the study protocol, ICH-GCP, applicable regulations, guidelines, and sponsor requirements.Some of what you will do:Identify investigator sites and participate...
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Clinical Research Associate
hace 1 mes
España Vhir A tiempo completoAcademic Research Organization (ARO) VHIR offers a vacant position within its Academic Research Organization for a Clinical Research Associate (Coordinator Sponsor Activities) in research projects related to the "PROYECTOS DE INVESTIGACIÓN CLÍNICA INDEPENDIENTE" file number ICI22/00106, funded by ISCIII and co-funded by FEDER, according to the call...
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Lead Clinical Research Associate
hace 7 meses
España United Biosource Corporation A tiempo completoUBC are currently recruiting within our clinical leadership team, we are looking to recruit a Lead CRA within the EU. UBC are a leading provider of pharmaceutical support services, partnering with life science companies to demonstrate value, ensure safe use and accelerate patient access to innovative medical products. Our services range from supporting the...
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Research Associate
hace 1 mes
España Rho, Inc. A tiempo completoOverviewJoin us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.At Rho, we’re committed to you just as you’re committed to us. You’ll have the...
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Associate Clinical Project Manager
hace 1 mes
España Ora A tiempo completoPOSITION TITLE: Associate Clinical Project Manager DEPARTMENT: Ora Europe LOCATION: Remote, UK, Spain, Italy or Poland 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...
