Lavori attuali relativi a Clinical Research Associate, Site Management Specialist - Milano, Lombardia - IQVIA LLC
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Clinical Research Associate
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Milano, Lombardia, Italia IQVIA A tempo pienoJob OverviewAs a Clinical Research Associate at IQVIA, you will play a critical role in the success of our clinical trials. You will be responsible for conducting site monitoring visits, administering protocol and related study training, and evaluating the quality and integrity of study site practices.Key ResponsibilitiesComplete therapeutic, protocol, and...
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Clinical Research Associate
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Milano, Lombardia, Italia Iqvia Argentina A tempo pienoJob 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.Key Responsibilities:Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with...
Clinical Research Associate, Site Management Specialist
2 mesi fa
IQVIA LLC is seeking a highly skilled Clinical Research Associate, Site Management to join our team. As a key member of our clinical research team, you will be responsible for conducting clinical monitoring visits, ensuring compliance with study protocols, and providing exceptional customer service to our clients.
Key Responsibilities- Conduct structured training programs to gain knowledge and skills required to independently conduct clinical monitoring visits.
- Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits, in accordance with contracted scope of work and good clinical practices.
- 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.
- 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.
- 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.
- Collaborate and liaise with study team members for project execution support as appropriate.
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- Equivalent combination of education, training, and experience may be accepted in lieu of degree.
- In possession of the local ministerial decree as per Italian requirements.
- Prior clinical experience preferred.
- Computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint.
- 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.
- Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
