Experienced CRA, Sponsor Dedicated - Italy

IQVIA LLC; Milano; In loco; EUR 34.000 - 67.000; Tempo pieno

Descrizione del lavoro

IQVIA LLC is seeking a Clinical Research Associate responsible for site monitoring and study management to ensure protocol adherence, data quality, and regulatory compliance across assigned sites in Italy. You will conduct monitoring visits, manage recruitment plans, and coordinate with site staff, with IQVIA's global leadership in clinical research services.

The role requires solid GCP/ICH knowledge, 3+ years on-site monitoring experience, and strong communication skills in English; proficiency

Competenze

• Bachelor's and Master's Degree in scientific discipline or health care.
• At least 3 years of on-site monitoring experience.
• CRA Certification according to Ministerial Decree dated 15.11.2011.
• GCP and ICH guidelines knowledge.
• Strong written and verbal English communication.
• Microsoft Word, Excel and PowerPoint proficiency; basic device familiarity.

Mansioni

• Perform site monitoring visits (selection, initiation, monitoring and close-out).
• Drive and track subject recruitment plan to enhance predictability.
• Administer protocol training and maintain site communications.
• Evaluate site adherence to GCP/ICH and regulatory requirements.
• Track regulatory submissions, recruitment, CRF completion and data queries.
• Maintain TMF and ISF documents per regulatory requirements.
• Document findings and action plans; prepare visit reports and follow-up letters.
• Collaborate with study team for project execution; support startup if needed.

Conoscenze

On-site monitoring experience

Communication skills

Time management

Financial management

GCP/ICH knowledge

English proficiency

Documentation and report writing

Team collaboration

Formazione

Bachelor's and Master's Degree in scientific discipline or health care

Strumenti

MS Word

Excel

PowerPoint

Laptop

iPhone/iPad

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 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 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 €33,900.00 - €66,700.00. 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.