📍 Location: Mesagne (BR), Italy
🕒 Working hours: Full-time
💼 Type: Curricular or extracurricular internship

About us

ClinOpsHub S.r.l., founded in 2014, is a Contract Research Organization (CRO) self-certified with AIFA since 2019.

We operate in the Clinical Research sector, providing services to pharmaceutical companies, investigational sites, laboratories, and other CROs, with a strong focus on quality, training, and the professional development of the people who join our team.

Who we are looking for

We are looking for a candidate to join our Clinical Operations Department as an intern, with a strong interest in gaining hands-on experience in the operational and documentation-related management of clinical studies.

The selected candidate will work alongside the team and will have the opportunity to gain direct exposure to the main activities performed within a CRO, progressively developing skills in clinical study management, study start-up, regulatory documentation, and support to monitoring activities.

What you will do

During the internship, you will have the opportunity to support the team in the following activities:

• supporting the management and filing of study-specific documentation within the Trial Master File (TMF) and the company’s electronic archives;
• supporting the preparation of Investigator Site Files (ISF) and related document management;
• collecting and checking site-specific documentation required during the study start-up phase;
• supporting the preparation and review of documentation required for the management of clinical studies;
• supporting the management of requests received from investigational sites;
• supporting the management of regulatory and authorization-related documentation;
• assisting with the preparation of ethical and regulatory submissions, including activities performed through CTIS;
• supporting the collection and organization of study-related data and the preparation of related reports;
• supporting communication with investigational sites, Sponsors, CROs, Vendors, Ethics Committees, and other stakeholders involved in the projects;
• progressively gaining knowledge of study protocols and the main regulations applicable to Clinical Research.

Requirements

We are looking for someone with:

• a degree in scientific or healthcare-related disciplines, preferably a Master’s degree or currently being completed;
• a strong interest in the Clinical Research sector;
• basic knowledge of Good Clinical Practice (GCP) and clinical trial methodology, considered a plus;
• good written and spoken English;
• good command of IT tools, particularly Microsoft Office;
• accuracy, attention to detail, and organizational skills;
• a team-oriented mindset and willingness to learn;
• the ability to work in a dynamic, structured, and regulated environment.

Previous professional experience in the Clinical Research sector is not required.

What we offer

The internship is designed as a hands-on training experience aimed at enabling the candidate to:

• gain a practical understanding of how a CRO operates;
• acquire hands-on experience in clinical study management;
• work alongside professionals in the field;
• develop operational, documentation, and regulatory skills;
• deepen their understanding of Clinical Operations and monitoring activities;
• build a first professional experience in the Clinical Research sector.

How to apply

Please send your CV and a short cover letter, telling us who you are, why you would like to enter the Clinical Research sector, and what you would like to learn from this experience, to:

cv@clinopshub.com

Inclusion and equal opportunities

This job posting is open to candidates of any gender, age, and nationality, in compliance with Italian Legislative Decree 198/2006 and Directive 2000/78/EC.

ClinOpsHub actively promotes an inclusive working environment and values diversity.

Privacy

Personal data will be processed in compliance with EU Regulation 679/2016 (GDPR) and applicable legislation on data protection and retention.