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Clinical Research Associate, Site Management - Italy

IQVIA

Milano

In loco

EUR 30.000 - 40.000

Tempo pieno

Oggi

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Descrizione del lavoro

A leading clinical research firm is seeking an entry-level Clinical Research Associate for their Milan office. This role involves conducting monitoring visits, ensuring compliance with study protocols, and maintaining documentation under supervision. Ideal candidates will have a Bachelor's Degree in a scientific discipline and relevant organizational skills, with proficiency in Microsoft Office. The position is structured to provide necessary training in clinical monitoring and project management, contributing to advancements in medical treatment and patient outcomes. Contract employment type applies.

Competenze

Bachelor's Degree or equivalent in a scientific field.
Possession of the local ministerial decree as per Italian requirements.
Prior clinical experience preferred, ideally 2 years.

Mansioni

Conduct site monitoring visits with supervision.
Administer protocol training to assigned sites.
Evaluate site practices for compliance with regulations.
Manage progress by tracking regulatory submissions.

Conoscenze

Organizational skills

Problem-solving skills

Effective communication skills

Time management skills

Knowledge of GCP and ICH guidelines

Computer proficiency in Microsoft Office

Formazione

Bachelor's Degree in a scientific discipline

Equivalent experience in clinical research

Strumenti

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Clinical Research Associate, Site Management - Italy

Job Overview

Engage in a structured training program to gain the knowledge and skills required to independently conduct clinical monitoring visits in accordance with the 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 establish 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) of 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 the 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 a scientific discipline or health care preferred.
Equivalent combination of education, training and experience may be accepted in lieu of a degree.
Possession of the local ministerial decree as per Italian requirements.
Prior clinical experience preferred.
Some organizations may require 2 years of clinical experience.
Computer skills including proficiency in Microsoft Word, Excel, PowerPoint and use of a laptop, iPhone and iPad (where applicable).
Written and verbal communication skills including good command of English.
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 https://jobs.iqvia.com.

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