Clinical Research Associate — Site Monitoring Expert

IQVIA; O'Fallon (IL); Sur place; USD 75 000 - 198 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Research Associate to perform site monitoring and related activities across multiple sites in the United States. You will drive site initiation, monitoring, close-out visits and ensure data quality in line with GCP and sponsor requirements.

Responsibilities include managing recruitment plans, training site staff, maintaining TMF/ISF documentation and collaborating with the study team. Relevant regulatory knowledge and strong communication are essential.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Equivalent combination of education, training and experience may be accepted.
• Written and verbal communication skills including good command of English.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Proficiency with Microsoft Word, Excel and PowerPoint.
• Good knowledge of GCP/ICH guidelines is desirable.

Responsabilités

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) per scope of work and Good Clinical Practice.
• Work with sites to drive subject recruitment plans and enhance study predictability.
• Administer protocol training to sites and maintain regular communication with sites.
• Evaluate site practices for protocol compliance and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion and data query resolution; may support start-up.
• Ensure site documents are filed in the TMF and ISF maintained per regulatory requirements.
• Create and maintain documentation of site management and monitoring findings.
• Collaborate with study team members for project execution support.

Formation

Bachelor's Degree in scientific discipline or health care preferred

Equivalent combination of education, training and experience accepted

Written and verbal communication skills in English

Organizational and problem-solving skills

Time and financial management skills

Ability to establish and maintain effective working relationships

Outils

EDC

CTMS

eTMF

IVRS/IWRS

Description du poste

IQVIA is seeking a Clinical Research Associate to perform site monitoring and related activities across multiple sites in the United States. You will drive site initiation, monitoring, close-out visits and ensure data quality in line with GCP and sponsor requirements.

Responsibilities include managing recruitment plans, training site staff, maintaining TMF/ISF documentation and collaborating with the study team. Relevant regulatory knowledge and strong communication are essential.