Clinical Research Associate
6 giorni fa
As a Clinical Research Associate at IQVIA, you will play a critical role in the success of our clinical trials. Your primary responsibility will be to conduct site monitoring visits, ensuring that study sites are in compliance with the study protocol, standard operating procedures, and 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, 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.
- Support the start-up phase of studies as needed.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans.
- Collaborate and liaise with study team members for project execution support as needed.
- 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.
- 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, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
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