Clinical Research Associate — Site Monitoring

IQVIA; Beverly Hills (CA); Presencial; USD 75.000 - 198.000; Jornada completa

Descripción de la vacante

IQVIA is hiring a Clinical Research Associate (CRA) to monitor study sites in the United States, ensuring that sites conduct studies and report data per the protocol, GCP, ICH, and sponsor requirements. This on-site role involves monitoring visits, training, and close collaboration with site staff.

The position requires a Bachelor’s degree in a scientific field (or healthcare) and at least 2 years of on-site CRA experience, with proficiency in EDC/CTMS/eTMF and strong English communication.

Formación

• Bachelor's degree in a scientific discipline or healthcare preferred.
• At least 2 years of independent on-site monitoring experience as a CRA.
• Good knowledge of GCP/ICH guidelines and regulatory requirements.
• Experience utilizing EDC, CTMS, eTMF, IVRS/IWRS, and other clinical trial systems.
• Strong written and verbal English communication.

Responsabilidades

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs 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 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, CRF completion and submission, and data query generation and resolution. May support start-up phase.
• 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 GCP and local regulatory requirements.
• 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.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Conocimientos

Clinical research

GCP/ICH knowledge

English communication

Site monitoring

Educación

Bachelor's degree in science/healthcare

Equivalent education/experience

Herramientas

EDC

CTMS

eTMF

IVRS/IWRS

MS Word

Excel

PowerPoint

Descripción del empleo

IQVIA is hiring a Clinical Research Associate (CRA) to monitor study sites in the United States, ensuring that sites conduct studies and report data per the protocol, GCP, ICH, and sponsor requirements. This on-site role involves monitoring visits, training, and close collaboration with site staff.

The position requires a Bachelor’s degree in a scientific field (or healthcare) and at least 2 years of on-site CRA experience, with proficiency in EDC/CTMS/eTMF and strong English communication.