Clinical Research Associate, Site Management - Italy

IQVIA Argentina; Milano; Ibrido; EUR 34.000 - 62.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Clinical Research Associate to perform site monitoring visits and ensure studies are conducted per protocol and regulations. You will manage site communications, training, and documentation.

You will track recruitment, CRF completion, data queries, and regulatory submissions, and support start-up and TMF/ISF maintenance. Strong English and MS Office skills are expected; some site financial tasks may be required.

Competenze

• Master's Degree in Life Sciences.
• CRA certification or equivalent regulatory training.
• Completion of CRA training program or prior monitoring experience.
• Basic knowledge of GCP/ICH guidelines.
• Proficiency with Microsoft Word, Excel and PowerPoint.
• Strong English communication skills.

Mansioni

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per SOW and GCP/ICH guidelines.
• Track subject recruitment plans and enhance predictability.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion and data queries; support start-up as needed.
• Ensure TMF/ISF documentation is maintained and accessible.
• Collaborate with study team for project execution support.
• Potentially support site recruitment planning and financial management per agreement.

Conoscenze

CRA certification

CRA training

English language

Organizational skills

Problem solving

Time management

Financial management

Formazione

Master's Degree in Life Sciences

Strumenti

Microsoft Word

Microsoft Excel

PowerPoint

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) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH 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

• Master's Degree in Life Sciences.
• In possession of CRA certification according to Ministerial requirements.
• Completion of CRA training program or prior monitoring experience.
• Basic 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 - €61,700.00. 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.