Clinical Research Associate
hace 4 semanas
Job Overview
As a Clinical Research Associate at IQVIA, you will play a critical role in ensuring the successful execution of clinical trials. Your primary responsibility will be to conduct site monitoring visits to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations, and sponsor requirements.
Key Responsibilities
- Perform site monitoring visits to assess the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Work with sites to adapt, drive, and track subject recruitment plans to enhance predictability.
- 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 and 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 that 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 GCP/ICH and local regulatory requirements.
- 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 appropriate.
Requirements
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- Equivalent combination of education, training, and experience may be accepted in lieu of degree.
- Basic knowledge of and skill in applying applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of 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.
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. Learn more at https://www.iqvia.com/
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