Job Title: Experienced CRA, Sponsor Dedicated - Italy
Job Location: Milan, Italy
Job Location Type: Home-based
Job Contract Type: Full time
Job Seniority Level:
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 Good Clinical Practice.
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) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP 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 and Master's Degree in scientific discipline or health care
Requires at least 3 years of year of on-site monitoring experience
In possession of CRA Certification according to Ministerial Decree dated 15.11.2011
Good 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.
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
This job is curated by Lifelancer.
Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
Please apply via Lifelancer platform to get connected to the application page and to find similar roles.
Lifelancer is a SaaS-based platform that connects freelance experts and remote job seekers with employers in the Life Science, Pharma, Biotech, Healthcare, Digital Health, and IT sectors. The platform enables talent hiring and job placement across domains including Bioinformatics, Data Science, and Medical fields, serving startups, SMEs, and established employers globally. Lifelancer addresses the growing demand for remote and freelance work in life science sectors, empowering both independent consultants and organizations to connect across borders. The company's DIY online platform facilitates talent-hiring, remote job opportunities, and freelance consulting services tailored to the life science and digital health industries.
