Clinical Research Associate, Site Management - Italy at IQVIA

Milan, Lombardy, Italy

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Not SpecifiedCompensation

Internship, Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Clinical ResearchIndustries

Requirements

Bachelor’s Degree in a scientific discipline or health care
In possession of local ministerial decree requirements as per Italian law
At least 1 year prior clinical experience preferred
Computer skills including proficiency in Microsoft Word, Excel, PowerPoint, use of a laptop computer, 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

Responsibilities

Complete appropriate therapeutic, protocol and clinical research training to perform job duties
Gain experience in study procedures by working with experienced clinical staff
Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices
Under close supervision, administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
Under close supervision, 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
Under close supervision, 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 Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements
Under close supervision, support start-up phase (if applicable)
Under close supervision, 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, learn key facets for successful development of project subject recruitment plan on a per site basis; suggest ideas for improving site recruitment plan in line with project needs to enhance predictability; assist in tracking subject site recruitment progress

Skills

GCP

ICH

Clinical Monitoring

Site Management

Protocol Training

Regulatory Compliance

CRF Management

TMF

ISF

Data Query Resolution

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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