Clinical Research Associate, Site Management
4 settimane fa
Job OverviewEngage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.Essential Functions• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.• Gain experience in study procedures by working with experienced clinical staff.• Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.• Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.• Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.• Under close supervision, ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) /International Conference on Harmonization (ICH) and local regulatory requirements.• Under close supervision may support start-up phase.• Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Collaborate and liaise with study team members for project execution support as appropriate.• If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment progress.Qualifications• Bachelor's Degree in scientific discipline or health care• In possession of local ministerial decree requirements as per Italian law.• At least 1 year prior clinical experience preferred.• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).• Written and verbal communication skills including good command of English language.• Organizational and problem-solving skills.• Effective time and financial management skills.• Ability to establish and maintain effective working relationships with coworkers, managers and clients.• Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.• Knowledge of applicable protocol requirements as provided in company training.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more
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Clinical Research Associate, Site Management
3 giorni fa
Milan, Italia Altro A tempo pienoClinical Research Associate, Site Management - ItalyJob OverviewEngage in a structured training program to gain the knowledge and skills required to independently conduct clinical monitoring visits in accordance with the study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.Essential FunctionsComplete...
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Clinical Research Associate, Site Management
3 giorni fa
Milan, Italia Altro A tempo pienoClinical Research Associate, Site Management - ItalyEngage in a structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.Essential FunctionsComplete appropriate...
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Clinical Research Associate, Site Management
3 giorni fa
Milan, Italia Altro A tempo pienoClinical Research Associate, Site Management - ItalyEngage in a structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.Essential FunctionsComplete appropriate...
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Clinical Research Associate, Site Management
3 giorni fa
Milan, Italia Altro A tempo pienoClinical Research Associate, Site Management - Italy Engage in a structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.Essential FunctionsComplete appropriate...
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Clinical Research Associate
5 giorni fa
Milan, Italia Informatica Software A tempo pienoClinical Research Associate ( CRA II or Senior CRA) - Romania - HybridICON plc is a world‑leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking...
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Clinical Research Associate, Site Management
4 settimane fa
Milan, Italy IQVIA A tempo pienoJob Overview Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. Essential Functions • Complete appropriate therapeutic, protocol and clinical research...
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Italy Clinical Site Monitor
3 giorni fa
Milan, Italia Altro A tempo pienoA clinical research services firm is seeking a Clinical Research Associate in Milan, Italy. This position involves conducting site monitoring visits, ensuring compliance with regulations, and maintaining study documentation. A Bachelor's degree in a scientific discipline or healthcare, along with at least one year of clinical experience, is preferred. The...
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Senior Home-Based Clinical Research Associate
3 giorni fa
Milan, Italia Altro A tempo pienoA leading global clinical research provider is seeking an experienced Clinical Research Associate to perform monitoring and site management work. Responsibilities include site visits, ensuring compliance with study protocols, and managing study progress. Candidates should hold a Bachelor's and Master's degree in a relevant field, possess CRA Certification,...
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Clinical Research Associate
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Milan, Italia Informatica Software A tempo pienoSenior CRA - Sponsor DedicatedICON plc is a world‑leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Senior Clinical Research Associate (CRA)...
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Clinical Research Associate
4 settimane fa
Milan, Italia MCR - Mediolanum Cardio Research s.r.l. A tempo pienoMediolanum Cardio Research è alla ricerca di un/a Clinical Research Associate (CRA) certificato/a di talento e motivato/a per unirsi al nostro team di ricerca clinica. Responsabilità Principali Il candidato ideale sarà responsabile della gestione e del monitoraggio delle attività degli studi clinici in conformità con i protocolli di ricerca, le...
