Clinical Research Associate, Site Management Specialist
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 appropriate 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. 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.
- 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 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.
- Collaborate and liaise with study team members for project execution support as appropriate.
- Assist in tracking subject site recruitment progress.
- 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.
- Some organizations may require 2 years of clinical experience.
- Computer skills including proficiency in the use of Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills, including a 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.
- Knowledge of applicable protocol requirements as provided in company training.
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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Milano, Lombardia, Italia Iqvia Llc A tempo pieno{"Job Title": "Clinical Research Associate, Site Management", "Job Overview": "We are seeking a highly skilled Clinical Research Associate to join our team at Iqvia Llc. As a Clinical Research Associate, you will be responsible for engaging in structured training programs to gain knowledge and skills required to independently conduct clinical monitoring...
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