Clinical Research Associate: Site Monitoring & Study Leadership

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

Descripción de la vacante

IQVIA is seeking a Clinical Research Associate to perform on-site monitoring visits across study sites, ensuring adherence to the protocol, GCP, and regulatory requirements. You will manage site communications, training, and data quality, with responsibility for regulatory submissions and TMF maintenance.

The ideal candidate has a Bachelor's degree in a scientific or health field and at least 2 years of independent CRA experience, with strong English skills and proficiency in EDC/CTMS/eTMF

Formación

• Bachelor's degree in scientific discipline or health care preferred.
• 2+ years of independent on-site monitoring experience as a CRA.
• Good knowledge of GCP and ICH guidelines.
• Experience with clinical trial systems (EDC/CTMS/eTMF).
• Strong written and verbal English communication; ability to manage multiple tasks.
• Proficient in Microsoft Word, Excel, PowerPoint and basic mobile devices.

Responsabilidades

• Perform site monitoring visits ( initiation, monitoring and close-out ) per scope of work and GCP.
• Collaborate with sites to drive subject recruitment in line with project needs.
• Administer protocol training and ensure regular communication with sites.
• Evaluate site conduct and regulatory compliance; escalate quality issues.
• Track regulatory submissions, recruitment, CRFs, data queries; support start-up phase.
• Maintain TMF and ISF documentation; generate visit reports and follow-up letters.
• Coordinate with study team for project execution and site management.
• Support development of recruitment plans and, if applicable, site budgeting and invoicing.

Conocimientos

On-site monitoring

Clinical Research Associate (CRA)

GCP

ICH guidelines

Regulatory knowledge

EDC/CTMS/eTMF

MS Office

English communication

Time management

Team collaboration

Educación

Bachelor's degree in scientific discipline or health care

Herramientas

EDC

CTMS

eTMF

IVRS/IWRS

Descripción del empleo

IQVIA is seeking a Clinical Research Associate to perform on-site monitoring visits across study sites, ensuring adherence to the protocol, GCP, and regulatory requirements. You will manage site communications, training, and data quality, with responsibility for regulatory submissions and TMF maintenance.

The ideal candidate has a Bachelor's degree in a scientific or health field and at least 2 years of independent CRA experience, with strong English skills and proficiency in EDC/CTMS/eTMF