Inhouse Clinical Research Associate
1 settimana fa
Inhouse Clinical Research Associate role at NovotechAbout the RoleThe Inhouse Clinical Research Associate (IHCRA) provides in‑house administrative support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.ResponsibilitiesSupport the Clinical Research Associates (CRAs) with in‑house activities on assigned projects.Co‑ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs.Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs.In collaboration with Regulatory Start Up team, co‑coordinate the distribution of ethics and regulatory submission documents including any amendments. Additionally, co‑coordinate submission of Import or Export applications including customs requirements as requested by the clinical team.Assist with maintenance of the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements. Update and maintain site milestones including EC/HA submissions and approvals, subject tracking and PISCF's, ensuring accuracy and completeness of the data.Creation of the Investigator Site Files, co‑ordinating the ordering, dispatch and tracking of trial materials (e.g. patient cards and diaries, lab supplies, drug supplies etc.) according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.Experience and QualificationsRelevant experience/qualifications in Life Sciences or related field or administration would be preferable. Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.Seniority levelEntry levelEmployment typeFull‑timeJob functionResearchIndustriesBiotechnology Research, Professional Services, and Research ServicesWe are proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programmes and ongoing development programmes. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.Referrals increase your chances of interviewing at Novotech by 2x.Get notified about new Clinical Research Associate jobs in Milan, Lombardy, Italy .#J-18808-Ljbffr
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Inhouse Clinical Research Associate
1 settimana fa
Milan, Italia Altro A tempo pienoInhouse Clinical Research Associaterole atNovotechAbout the Role The Inhouse Clinical Research Associate (IHCRA) provides in‑house administrative support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.ResponsibilitiesSupport the Clinical Research Associates...
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In-House Clinical Research Associate: Trial Docs
1 settimana fa
Milan, Italia Altro A tempo pienoA leading clinical research organization is seeking an Inhouse Clinical Research Associate in Milan to provide administrative support to the clinical team, manage clinical study documentation, and assist in regulatory submissions. Candidates are expected to have relevant qualifications in Life Sciences, strong administration skills, and preferably some...
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Clinical Research Associate
3 giorni fa
Milan, Italia Altro A tempo pienoJoin to apply for the Clinical Research Associate role at MedpaceContinue with Google Continue with GoogleJoin to apply for the Clinical Research Associate role at MedpaceThe Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference...
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Clinical Research Associate
3 giorni fa
Milan, Italia Altro A tempo pienoJoin to apply for theClinical Research Associaterole atMedpace Continue with Google Continue with Google Join to apply for theClinical Research Associaterole atMedpace The Clinical Research Associate position at Medpace offers the unique opportunity to have anexciting careerin the research of drug and medical device development whilemaking a differencein the...
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Clinical Research Associate — Regulatory
1 settimana fa
Milan, Italia Altro A tempo pienoA clinical research firm in Italy is seeking a Clinical Research Associate to manage recruitment for investigators and monitor clinical sites. The candidate will conduct submissions, ensure compliance, and act as a primary contact for regulations. Must have excellent knowledge of the clinical trial process and be fluent in English and Italian. The role...
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Clinical Research Associate
1 settimana fa
Milan, Italia Altro A tempo pienoAs 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 clinical sites, maintenance of study files, conduct of pre‑study, initiation visits, regular visits and close‑out visits, and liaison with vendors...
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Clinical Research Associate II
1 settimana fa
Milan, Italia Altro A tempo pienoCompany Description PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description As a Clinical Research Associate at PSI Italy...
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Clinical Research Associate II
1 settimana fa
Milan, Italia Altro A tempo pienoCompany DescriptionPSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.Job Description As a Clinical Research Associate at PSI Italy you...
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Clinical Research Associate, Site Management
1 settimana fa
Milan, Italia Altro A tempo pienoJob 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...
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Clinical Research Associate, Site Management
1 settimana fa
Milan, Italia Altro 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...
