Experienced CRA, Sponsor Dedicated - Italy

IQVIA Inc; Lombardia; On-site; EUR 34,000 - 67,000; Full time

Job summary

IQVIA is seeking a site monitoring professional to ensure that sites conduct the study per protocol and report data as required. You will perform monitoring visits, manage recruitment plans, train sites, and maintain regulatory compliance with TMF/ISF controls.

The role requires 3+ years of on-site monitoring, CRA certification, strong GCP/ICH knowledge, and excellent English communication. Collaboration with study teams and potential start-up support are included.

Qualifications

• Requires at least 3 years of on-site monitoring experience.
• Certified as CRA per Ministerial Decree 15.11.2011.
• Strong knowledge of GCP and ICH guidelines.
• Proficient in English; excellent written and verbal communication.
• Good time and financial management skills.
• Solid regulatory knowledge applicable to clinical trials.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP.
• Collaborate with sites to drive and track subject recruitment plans.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol adherence and quality issues.
• Track regulatory submissions, CRF completion, queries, and data management; may support start-up.
• Ensure TMF and ISF documentation is filed and maintained.
• Prepare visit reports and follow-up letters; support project execution with the study team.
• Possibly support site financial management per agreement and invoicing.

Skills

On-site monitoring

CRA Certification

GCP/ICH knowledge

English communication

Time management

Financial management

Stakeholder management

Problem solving

Education

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

Tools

Microsoft Word

Microsoft Excel

PowerPoint

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 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 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.

About IQVIA

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

Hiring Integrity Statement

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.