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

Milan, Lombardy, Italy

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Clinical ResearchIndustries

Requirements

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

Responsibilities

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

Skills

Key technologies and capabilities for this role

GCPICH guidelinesSite MonitoringProtocol TrainingSubject RecruitmentRegulatory SubmissionsCRF CompletionTMF ManagementISF MaintenanceClinical Trial Management

Questions & Answers

Common questions about this position

Is this position remote or home-based?

Yes, this is a home-based position in Italy.

What qualifications and experience are required for this role?

Candidates need a University Bachelor's Degree and Master's Degree in a scientific discipline or health care, 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, and excellent command of English.

What key skills are needed for this Clinical Research Associate position?

Essential skills include organizational, time management and problem-solving skills, ability to establish and maintain effective working relationships with coworkers, managers, and clients, and flexibility to travel along with a Driver’s license class B.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does IQVIA do as a company?

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, creating intelligent connections to accelerate the development and commercialization of innovative medical treatments.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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