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

IQVIA; Lombardia; In loco; EUR 34.000 - 63.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Clinical Research Associate to monitor sites in Lombardia and ensure study data is collected per protocol and regulations. You will conduct visits, train site staff, and liaise with the study team to resolve issues and maintain high-quality data.

The role requires a scientific degree, CRA certification, pharma/clinical trial experience, and willingness to travel. Strong English, organizational skills, and proficiency in MS Office are essential.

Competenze

• Bachelor's and Master's degrees in scientific discipline or health care.
• CRA Certification/registered as required by Ministerial Decree 15.11.2011.
• Experience in Pharma industry and/or Clinical Trials environment.
• Very good computer skills including MS Office.
• Excellent command of English.

Mansioni

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP/ICH guidelines.
• Coordinate with sites to recruit subjects per project needs to improve predictability.
• Administer protocol training to sites and maintain regular communication to manage expectations and issues.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate issues.
• Track regulatory submissions, recruitment, CRF completion, data queries; support startup if needed.
• Ensure TMF completeness and ISF accuracy per GCP and local rules.
• Document site management findings and action plans; generate reports and letters.
• Collaborate with study team for project execution; assist recruitment plan by site if applicable.
• Manage site finances per trial agreement and gather invoices if applicable.

Conoscenze

MS Office

English proficiency

Communication skills

Time management

Problem-solving

Teamwork

Travel flexibility

Driver's license

Formazione

Bachelor's degree

Master's degree

Strumenti

MS Office

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) 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 IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is €34,300.00 - €63,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.