Clinical Research Associate
3 giorni fa
As a Clinical Research Associate at IQVIA, you will engage in a structured training program to gain the knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
Key Responsibilities- Complete therapeutic, protocol, and clinical research training to perform job duties.
- Gain experience in study procedures by working with experienced clinical staff.
- Perform site monitoring visits (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.
- Support start-up phase as needed.
- 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.
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- Equivalent combination of education, training, and experience may be accepted in lieu of degree.
- Possession of the local ministerial decree as per Italian requirements.
- Prior clinical experience preferred.
- Computer skills, including proficiency in 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 the 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.
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
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