Clinical Research Associate - Site Monitoring & Data

IQVIA; Santa Fe (NM); Sur place; USD 75 000 - 198 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Research Associate to perform on-site monitoring and site management in accordance with GCP and ICH guidelines. You will support regulatory submissions, site training, and data query resolution across assigned studies.

Required are 2+ years of CRA experience, strong English communication, and proficiency with EDC/CTMS/eTMF systems. Travel to sites and collaboration with study teams are essential.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience as a CRA.
• Equivalent combination of education, training and experience may be accepted.
• Good knowledge of clinical research regulatory requirements (GCP & ICH).

Responsabilités

• Perform site monitoring visits per scope of work and GCP.
• Engage sites to recruit subjects and track recruitment plans.
• Administer protocol training and maintain site communication.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion, and data queries.
• Maintain TMF/ISF documents and site files per regulatory requirements.
• Create reports and follow-up letters; collaborate with study team.
• Support startup activities and site-level recruitment plans as needed.
• Possibly manage site finances per trial agreement and local rules.

Connaissances

CRA experience

GCP knowledge

ICH guidelines

EDC/CTMS/eTMF

English communication

Formation

Bachelors in science or healthcare

Outils

EDC

CTMS

eTMF

IVRS/IWRS

Description du poste

IQVIA is seeking a Clinical Research Associate to perform on-site monitoring and site management in accordance with GCP and ICH guidelines. You will support regulatory submissions, site training, and data query resolution across assigned studies.

Required are 2+ years of CRA experience, strong English communication, and proficiency with EDC/CTMS/eTMF systems. Travel to sites and collaboration with study teams are essential.