Vedere l'offerta completa

SENIOR CRA, SPONSOR DEDICATED - ITALY

Descrizione dell'offerta di lavoro

Job Overview Perform monitoring and site management work for a variety of protocols, site and therapeutic areas.
Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.
., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• 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.
May support start-up phase.
• 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 GCP \/ ICH and local regulatory requirements.
• 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.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications • Degree in scientific discipline or health care preferred.
• Requires at least 3 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.
., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Strong therapeutic and protocol knowledge as provided in company training.
• 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.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.
We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
Learn more at https.
/\/jobs.
qvia.
om ","applicantLocationRequirements".
{"@type":"Country","name":"IT
Vedere l'offerta completa

Dettagli dell'offerta

Azienda
  • Imprecisato
Località
  • Tutta l'Italia
Indirizzo
  • Imprecisato - Imprecisato
Data di pubblicazione
  • 25/10/2024
Data di scadenza
  • 22/01/2025
Senior consultant
Key Partner srl

Precedente coinvolgimento in progetti complessi per grandi committenze pubbliche o private, con un discreto grado di autonomia relazionale con il cliente o lo sponsor interno... la tua opportunita’ nell’ambito di un’importante strategia di crescita dell’organizzazione nelle proprie divisioni services......

Architect senior su Roma o Milano
Sincrono formazione srl

Ruolo ricoperto: architect senior competenze richieste: - google cloud -aws -scala -spark -python -google cloud bigquery -google cloud dataproc -google cloud dataflow -hive competenze linguistiche: -inglese: livello b1 seniority: +3 anni sede di lavoro: residenza in una delle città menzionate: milano......

Sistemista linux senior
Tecninf s.p.a.

Ricerca profilo professionale di sistemista linux senior... la risorsa dovrà avere esperienza pregressa in attività sistemistica di almeno 5 anni comprovata esperienza in realtà di medio/grande dimensione esperienza su tecniche di installazione, configurazione e risoluzioni dei problemi in ambiente linux......

Senior Power BI & Business Intelligence Developer
Programs & Projects Consulting S.r.L.

Societa' che opera con successo da oltre un ventennio su tutto il territorio nazionale, nel campo dell'ict a 360°, la cui mission delle sue attivita' sono le prestazioni ad alto valore aggiunto, ossia lo studio di soluzioni e l'erogazione di servizi inerenti il settore dell'information & communication......

Greek Beauty Advisor Expert – Skin for Majorel Italy
Majorel Italy srl

The ideal candidate has a strong orientation towards the achievement of objectives, excellent interpersonal skills and shows a propensity to manage telephone contact... explore you careers possibilities and work on your personal development... live chat, phone, emails, webforms, social 1:1) by providing......

Greek Beauty Advisor Expert – Hair Color for Majorel Italy
Majorel Italy srl

The ideal candidate has a strong orientation towards the achievement of objectives, excellent interpersonal skills and shows a propensity to manage telephone contact... explore you careers possibilities and work on your personal development... in the same way, our offered positions can be developed by......

English Beauty Advisor Expert – Skin for Majorel Italy
Majorel Italy srl

The ideal candidate has a strong orientation towards the achievement of objectives, excellent interpersonal skills and shows a propensity to manage telephone contact... explore you careers possibilities and work on your personal development... live chat, phone, emails, webforms, social 1:1) by providing......

English Beauty Advisor Expert – Hair Color for Majorel Italy
Majorel Italy srl

The ideal candidate has a strong orientation towards the achievement of objectives, excellent interpersonal skills and shows a propensity to manage telephone contact... explore you careers possibilities and work on your personal development... in the same way, our offered positions can be developed by......

Greek Beauty Advisor for Majorel Italy
Majorel Italy srl

The ideal candidate has a strong orientation towards the achievement of objectives, excellent interpersonal skills and shows a propensity to manage telephone contact... above all, enjoy the experience of working with this highly prestigious brand l’oréal group!... explore you careers possibilities and......

German beauty advisor - hair color for majorel italy
Majorel italy srl

The ideal candidate has a strong orientation towards the achievement of objectives, excellent interpersonal skills and shows a propensity to manage telephone contact... explore you careers possibilities and work on your personal development... live chat, phone, emails, webforms, social 1:1) by providing......