Clinical Research Associate

IT51; Modena; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading clinical research organization in Italy is seeking a Site Manager to ensure compliance with study protocols and coordinate site activities. Responsibilities include monitoring site practices, ensuring adherence to GCP guidelines, and managing project timelines. Ideal candidates should have a Bachelor’s degree in a relevant field, strong organizational skills, and proficiency in Microsoft Office. This position offers a full-time role within a dynamic team.

Competenze

• Bachelor's degree or equivalent combination of education, training, and experience.
• Some require CRA training or prior monitoring experience.
• Good command of English required.

Mansioni

• Perform site monitoring visits according to GCP and ICH guidelines.
• Evaluate quality of site practices and escalate issues.
• Manage progress of studies tracking submissions and approvals.

Conoscenze

Basic knowledge of clinical research regulatory requirements

Written and verbal communication skills

Organizational and problem-solving skills

Effective time management

Proficiency in Microsoft Office

Formazione

Bachelor's Degree in scientific discipline or health care

Strumenti

Microsoft Word

Excel

PowerPoint

Descrizione del lavoro

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., 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), verify that the Investigators 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.

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

Bachelor's Degree, Degree in scientific discipline or health care preferred.

Equivalent combination of education, training, and experience may be accepted in lieu of degree.

Some organizations require completion of CRA training program or prior monitoring experience.

Basic knowledge of and skill in applying applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).

Good 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.

Company Overview

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.

Additional Information

Employment Type: Full-Time

Experience: years

Vacancy: 1