Site Monitoring and Management - IQVIA
Job Overview
IQVIA is seeking a dedicated Clinical Research professional to perform monitoring and site management activities for clinical studies. This role ensures that study sites comply with the study protocol, applicable regulations, guidelines, and sponsor requirements, contributing to the overall success of clinical trials.
Essential Functions
Site Monitoring Visits: Conduct site monitoring visits, including selection, initiation, monitoring, and close-out visits, in compliance with regulatory requirements (GCP and ICH guidelines).
Recruitment Management: Work with study sites to adapt and track subject recruitment plans in line with project needs to ensure timely enrollment and enhance predictability.
Protocol Training: Administer protocol training and related study instructions to assigned sites, maintaining regular communication to manage project expectations and resolve issues.
Study Quality Assurance: Evaluate site practices to ensure proper protocol conduct and adherence to regulatory standards, escalating quality concerns as necessary.
Study Progress Management: Track the progress of assigned studies, including regulatory submissions, recruitment, case report form (CRF) completion, data query generation, and resolution. May support the start-up phase.
Document Management: Ensure that all site documents are available for filing in the Trial Master File (TMF) and that the Investigator's Site File (ISF) complies with GCP and local regulations.
Documentation and Reporting: Maintain proper documentation of site management activities, monitoring visit findings, and action plans by submitting regular visit reports, follow-up letters, and other required study documentation.
Collaboration: Collaborate with the study team for project execution support as needed.
Site Financial Management: If applicable, assist with financial management for sites, ensuring compliance with clinical trial agreements and retrieving invoices as required by local guidelines.
Qualifications
Education: Bachelor’s Degree in a scientific discipline or healthcare-related field is preferred.
Experience:
At least 1 year of on-site monitoring experience.
Equivalent combination of education, training, and experience may be considered in lieu of a degree.
Regulatory Knowledge: Strong understanding of clinical research regulations, including GCP and ICH guidelines.
Skills:
Proficiency in Microsoft Word, Excel, PowerPoint, and basic computer skills (laptop, iPhone, iPad, as applicable).
Excellent written and verbal communication skills, with a strong command of the English language.
Strong organizational, problem-solving, time management, and financial management skills.
Relationship Management: Ability to establish and maintain effective relationships with coworkers, managers, and clients.
About IQVIA
IQVIA is a global leader in providing clinical research services, commercial insights, and healthcare intelligence. We are committed to accelerating the development and commercialization of innovative medical treatments to improve patient outcomes worldwide. To learn more, visit IQVIA Careers.
This role offers a great opportunity to contribute to the efficient management of clinical trials while working in a dynamic, global company.
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Brazil | Sao paulo |Attica :
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