16 annunci per il ruolo di audit supervisor (recruiting in corso)

Clinical Research Associate I - Full Service Operations Model - Italy
Fortrea —Milano, Lombardia
- 32.200 € - 48.840 € all'anno
- Tempo pieno
- Inglese
- Laurea magistrale
- Laurea triennale
17 ore
Supplier Quality Engineer
Rotork —Porcari, Toscana
- Tempo pieno
- Gestionale
- Inglese
- Microsoft Office
Candidatura rapida
Manufacturing Process Expert
Thermo Fisher Scientific —Monza, Lombardia
- Tempo pieno
- Gestionale
- Inglese
- Produzione
14 giorni
Biologo di campo - Pest Control - Lazio/Campania
Rentokil Initial —Roma, Lazio
- 24.000 € - 30.000 € all'anno
- Tempo pieno
- Medicina
- Inglese
- Maturità
Candidatura rapida
Individual Giving Data Engineer
World Food Programme —Roma, Lazio
- Tempo pieno
- Remoto
- Informatica
- Gestionale
- DevOps
2 giorni
Senior Maintenance Engineer
Bolton Group —Cermenate, Lombardia
- Tempo pieno
- Microsoft Excel
- Gestionale
- Ingegneria
Production Planner
Brenntag S.p.A. —Trezzano sul Naviglio, Lombardia
- 30.000 € - 35.000 € all'anno
- Produzione
Candidatura rapida
Site Supervisor Elettrico
Cattaneo Impianti —Lomazzo, Lombardia
- 36.000 € - 45.000 € all'anno
- Manutenzione
- Microsoft Office
- Maturità
Senior Risk & Compliance
BDO ITALIA S.p.A —Bologna, Emilia-Romagna
- Inglese
- Laurea magistrale
- Competenze organizzative
Candidatura rapida
Welding/Painting QC Supervisor
FAM ENERGY SERVICE Srl —Milano, Lombardia
- 3.000 € - 4.000 € al mese
- PMP
- Cantiere edile
- AWS
Senior Risk Consultant
BDO ITALIA S.p.A —Milano, Lombardia
- Inglese
- Laurea magistrale
- Competenze organizzative
Candidatura rapida
Corporate IT Auditor
ATS Automation Tooling Systems Inc. —Parma, Emilia-Romagna
- Laurea triennale
- IT
Concierge - Palazzo Sanzio Roma
Radisson Hotel Group —Roma, Lazio
- 27.000 € - 28.000 € all'anno
- Tempo pieno
- Inglese
- Hotel
- Capacità di comunicazione
Candidatura rapida
Consulenti Energetici
IMC Holding —Latina, Lazio
- Remoto
- Vendite
Candidatura rapida
HSE Engineer Ravenna
ISS International SpA —Ravenna, Emilia-Romagna
- 25.000 € - 35.000 € all'anno
- Tempo pieno
- In presenza
Maintenance Supervisor
Brenntag S.p.A. —Bergamo, Lombardia
- 50.000 € - 60.000 € all'anno
- Gestionale
- Manutenzione
- Maturità
Candidatura rapida
19 ore

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Clinical Research Associate I - Full Service Operations Model - Italy

Fortrea -
Milano, Lombardia

Candidati adesso

Dettagli della posizione

Tempo pieno
32.200 € - 48.840 € all'anno
17 ore fa

Qualifiche

Inglese
Laurea magistrale
Laurea triennale
Italiano

Descrizione completa della posizione

Job Overview:

Site monitoring and site management responsibility for clinical studies according to Company, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. Assures the implementation of project plans, as assigned.

Summary of Responsibilities:

Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.
Responsible for all aspects of site management as prescribed in the project plans.
General On-Site Monitoring Responsibilities.
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
Monitor data for missing or implausible data.
Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
Ensure audit readiness at the site level.
Travel, including air travel, may be required and is an essential function of the job.
Prepare accurate and timely trip reports.
Interact with internal work groups to evaluate needs, resources, and timelines.
Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
Responsible for all aspects of registry management as prescribed in the project plans.
Undertake feasibility work when requested.
Participate in and follow-up on Quality Control Visits (QC) when requested.
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned 18) Assist Senior CRA with managing investigator site budgets.
Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.

Qualifications (Minimum Required):

MANDATORY Master's Degree (5-year university degree) in a scientific discipline, compliant with the requirements of the Italian Ministerial Decree of 15 November 2011
MANDATORY CRA certification compliant with the Italian Ministerial Decree of 15 November 2011 (DM 15/11/2011).
MANDATORY Fluent in Italian and in English, both written and verbal.

Experience (Minimum Required):

Minimum 1 year of experience as independent monitor .
Basic understanding of Regulatory Guidelines.
Ability to work within a project team.
Good planning, organization, and problem-solving skills.
Good computer skills with good working knowledge of a range of computer packages.
Works efficiently and effectively in a matrix environment.
Valid Driver's License.

The base salary range for this role is EUR 32.200 - EUR 48.840 gross per year, which may vary as per working schedule (full or part-time). The final offer will be determined based on objective and job-related criteria such as experience, qualifications, and scope of responsibilities, in line with our internal job classification framework and the applicable collective labour agreement (CCNL). This role may also be eligible for additional compensation, such as bonus and benefits, in accordance with company policies

Learn more about our EEO & Accommodations request here .

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