CLINICAL RESEARCH ASSOCIATE - Farmapiù - Lavoropiù S.p.A.

Farmapiù Milano has partnered with a global Contract Research Organization who are recruiting for a Senior CRA to join them on a permanent basis. This position is based in Milan.

Job Purpose:

Responsable for project activities associated with monitoring functions of phase I through to phase IV clinical research studies and desirable experience in CA/EC submission and Contract Management, while continuing to develop knowledge of drug development process, ICH/GCP, and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and SOPs.

Job Responsibilities:

- Conduct Pre-Study Visit (PSV), Site Initiation Visit (SIV), Interim Monitoring (IMV), and close-out visit (COV)

- Assist with Study Start-Up activities including feasibility, pre-study activities and site selection

- Collect, review and track essential/regulatory documents

- Partecipate in investigator, client and project team meetings

- Storage, dispensation, and accountability of all IP (Investigational Product) and trial-related materials

- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager

- Conduct remote monitoring and complete the related activities in accordance with study specific Monitoring Plan

- Utilize systems and reports to track subject status, subject CRF (case report form) retrieval / SDV (source document review), regular documents and IP

- Assist with project-specific activities as member of Project Team

- May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures

- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans

- Identify site issue and implement corrective actions or escalate as appropriate

- Liaise with Clinical Trial Management for data cleaning activities

- Assist as preparing and coordinating Investigator and client meetings and attend meetings as necessary

- Where applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to EC, IEC, Regulatory Authorities, Competent Authorities ot Institutions Administration Boards, and follow-up the evaluation process until approval is available

- Provide regular updates to Sponsor/Client

Requirements:

- Ability to manage required travel of up to 75% on a regular basis.

- minimum 2-4 years of clinical trial monitoring experience

- Bachelor’s degree or higher in allied health field such as nursing, pharmacy, or health/natural science

- Fluency in Italian and a high level of English language are required

Apply now:

If you are interested in learning more or applying to this opportunity then please send your CV to farma.milano@lavoropiu.it

Il presente annuncio è rivolto ad entrambi i sessi, ai sensi delle leggi 903/77 e 125/91 e a persone di tutte le età e tutte le nazionalità, ai sensi dei decreti legislativi 215/03 e 216/03.

Ti chiediamo di prendere visione dell'informativa sulla privacy consultabile al link www.lavoropiu.it/privacy e di inserire nel CV l'autorizzazione al trattamento dei tuoi dati personali ai sensi del Regolamento UE n. 679/2016 e della legislazione italiana vigente.

Ti preghiamo di non inserire dati appartenenti a particolari categorie (dati che rivelino l'origine razziale o etnica, le opinioni politiche, le convinzioni religiose o filosofiche, o l'appartenenza sindacale, dati genetici, dati biometrici intesi a identificare in modo univoco una persona fisica, dati relativi alla salute o alla vita sessuale o all'orientamento sessuale" (Regolamento U.E. n. 679 del 2016)

Per rispondere all'annuncio, inviare il proprio CV a farma.milano@lavoropiu.it citando il riferimento 0101.107-GD.CRA

Farmapiù è la divisione specializzata nella ricerca e selezione di personale qualificato di Lavoropiù spa. L'organizzazione italiana ha uffici a Milano, Bologna, Firenze e Roma ed opera prevalentemente nei settori chimico, farmaceutico, biomedicale e cosmetico.

Per un approfondimento su Farmapiù e per maggiori dettagli sulle ricerche in corso consultare il sito http://www.lavoropiu.it/partner/farmapiu/