Clinical Research Associate, Site Management – Italy

Job title:

Clinical Research Associate, Site Management – Italy

Company:

IQVIA

Job description

Job 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 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 at

Expected salary

Location

Milano

Job date

Fri, 07 Mar 2025 08:09:41 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesin.eu) you saw this job posting.

yonnetim

Published by
yonnetim

Recent Posts

Leading Consultancy in Clinical Biochemistry

Job title: Leading Consultancy in Clinical Biochemistry Company: Frederiksberg Hospital Job description The Department of…

34 seconds ago

System Analyst (Senior/Medior)

Job title: System Analyst (Senior/Medior) Company: Hays Job description Your new company14+ éves, 90+ fős…

6 minutes ago

Call for Expressions of Interest: MSCA Postdoctoral Fellowships 2025

Job title: Call for Expressions of Interest: MSCA Postdoctoral Fellowships 2025 Company: TU Delft Job…

11 minutes ago

Bar and Waiting Team Member

Job title: Bar and Waiting Team Member Company: Center Parcs Job description A range of…

14 minutes ago

Senior Recruiter – French speaker

Job title: Senior Recruiter - French speaker Company: Alexander Mann Solutions Job description Global, culturally…

19 minutes ago

Vocational Coach for Health and Social Care

Job title: Vocational Coach for Health and Social Care Company: College of Haringey, Enfield and…

29 minutes ago
If you dont see Apply Button. Please use Non-Amp Version