Experienced Clinical Research Associate, IQVIA Biotech - Home based, Italy

IQVIA; Milano; Remoto; EUR 38.000 - 50.000; Tempo pieno

Descrizione del lavoro

A leading global clinical research provider is seeking an experienced Clinical Research Associate to perform monitoring and site management work. Responsibilities include site visits, ensuring compliance with study protocols, and managing study progress. Candidates should hold a Bachelor's and Master's degree in a relevant field, possess CRA Certification, and have experience in the Pharma industry or clinical trials. The position is contract-based and located in Milan, Lombardy, Italy, with flexibility required for travel.

Competenze

• Possession of CRA Certification as required by Ministerial Decree dated 15.11.2011.
• Experience in Pharma Industry or Clinical Trials environment.
• Driver’s license class B.

Mansioni

• Perform site monitoring visits (selection, initiation, monitoring, and close-out visits).
• Work with sites to track subject recruitment plan.
• Administer protocol and training to assigned sites.
• Evaluate quality and integrity of study site practices.
• Manage progress of assigned studies.
• Ensure site documents are available for filing.
• Create and maintain documentation regarding site management.
• Collaborate with study team members for project support.

Conoscenze

Very good computer skills including MS Office

Excellent command of English language

Organizational skills

Time management skills

Problem-solving skills

Ability to establish effective working relationships

Flexibility to travel

Formazione

University Bachelor's Degree in scientific discipline or health care

Master's Degree in scientific discipline or health care

CRA Certification

Descrizione del lavoro

Experienced Clinical Research Associate, IQVIA Biotech - Home based, Italy

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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) 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

• University Bachelor's Degree and Master's Degree in scientific discipline or health care
• In possession of CRA Certification as required by Ministerial Decree dated 15.11.2011
• Experience in Pharma Industry, and/or Clinical Trials environment
• Very good computer skills including MS Office
• Excellent command of English language
• Organizational, time management and problem‑solving skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Flexibility to travel
• Driver’s license class B

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

Seniority level

Mid‑Senior level

Employment type

Contract

Job function

Research, Analyst, and Information Technology

Industries

Hospitals and Health Care

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