Clinical Research Monitor: Site Management & Data Quality

Regulatory Jobs; Carlsbad (CA); Sur place; USD 72 000 - 189 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Research Associate to monitor study sites and ensure compliant data reporting per protocol and regulatory guidelines. The role requires on-site visits, coordination with investigative sites, and documentation in the TMF/ISF.

Strong English communication and regulatory knowledge are essential. Responsibilities include site initiation, monitoring, close-out visits, training, and tracking regulatory submissions, recruitment, and data queries.

Qualifications

• Requires minimum 1 year of independent on-site monitoring experience as a CRA.
• Bachelor's Degree in scientific discipline or health care preferred.
• Knowledge of GCP/ICH guidelines and related regulations.
• Proficient in MS Word, Excel, PowerPoint; familiarity with iPhone/iPad is a plus.
• Strong English written and verbal communication, organizational and problem-solving skills.

Responsabilités

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP/ICH.
• Collaborate with sites to drive subject recruitment plans.
• Administer protocol training and maintain regular communication with sites.
• Track regulatory submissions, recruitment, CRF completion, and data queries.
• Ensure TMF/ISF documentation is accurate and up to date.
• Coordinate with study team for project execution.

Connaissances

On-site monitoring

English communication

Regulatory knowledge (GCP/ICH)

Formation

Bachelor's Degree in scientific discipline or health care preferred

Outils

Microsoft Word

Excel

PowerPoint

iPhone

iPad

Description du poste

IQVIA is seeking a Clinical Research Associate to monitor study sites and ensure compliant data reporting per protocol and regulatory guidelines. The role requires on-site visits, coordination with investigative sites, and documentation in the TMF/ISF.

Strong English communication and regulatory knowledge are essential. Responsibilities include site initiation, monitoring, close-out visits, training, and tracking regulatory submissions, recruitment, and data queries.