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

TheFork; Remoto; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading clinical research firm is looking for an Experienced Clinical Research Associate to perform monitoring and site management tasks across studies. Responsibilities include site monitoring visits, managing recruitment plans, administering training, and ensuring compliance with regulations. The ideal candidate holds a Bachelor's and Master's degree in a scientific field with CRA certification, and has experience in the pharmaceutical or clinical trials industry. The position is remote, based in Milan, Italy.

Competenze

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

Mansioni

• Perform site monitoring visits in accordance with Good Clinical Practice (GCP).
• Work with sites to adapt and drive subject recruitment plans.
• Administer protocol and related study training to sites.
• Evaluate the quality of study site practices and escalate issues.
• Manage progress of assigned studies by tracking regulatory submissions.
• Ensure site documents are available for filing in the Trial Master File.
• Create and maintain documentation regarding site management.
• Collaborate and liaise with study team members for support.

Conoscenze

Computer skills including MS Office

Excellent command of English language

Organizational skills

Time management skills

Problem-solving skills

Ability to establish effective relationships

Flexibility to travel

Formazione

University Bachelor's Degree in scientific discipline

Master's Degree in scientific discipline or health care

CRA Certification

Descrizione del lavoro

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

Remoto

EUR 40.000 - 60.000

Milan, Italy

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

BIQVIA 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 atIQVIA 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.