Clinical Research Associate, Site Management - Italy

IQVIA; Turbigo; On-site; EUR 30,000 - 50,000; Full time

Job summary

IQVIA is seeking a CRA to monitor and manage clinical research sites in Italy, ensuring compliance with study protocols and regulations. The ideal candidate will hold a Master’s degree in Life Sciences and have CRA certification. Responsibilities include conducting site monitoring visits, ensuring data integrity, and managing study documentation. Proficiency in Microsoft Office tools and strong communication skills are essential. This role requires effective time management and the ability to collaborate effectively with study team members.

Qualifications

• In possession of CRA certification according to Ministerial requirements.
• Completion of CRA training program or prior monitoring experience.
• Basic knowledge of clinical research regulatory requirements (GCP and ICH guidelines).
• Good therapeutic and protocol knowledge as provided in company training.

Responsibilities

• Perform site monitoring visits in accordance with regulatory requirements.
• Work with sites to adapt and track subject recruitment plan.
• Administer protocol and related study training to assigned sites.
• Evaluate the quality and integrity of study site practices.
• Manage the progress of assigned studies including regulatory submissions.
• Ensure site documents are available for filing.
• Create and maintain documentation regarding site management.

Skills

Written and verbal communication skills (English)

Organizational skills

Problem-solving skills

Effective time management

Financial management skills

Education

Master’s Degree in Life Sciences

CRA certification

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

iPhone

iPad

Job description

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 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.
• 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

• Master’s Degree in Life Sciences.
• In possession of CRA certification according to Ministerial requirements.
• 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.