Clinical Research Associate 2, IQVIA

IQVIA•Durham, NC

2d•Onsite

About The Position

IQVIA is seeking a Clinical Research Associate II with independent on-site monitoring experience to join our team. We are looking for professionals with experience in one or more of the following therapeutic areas: Central Nervous System (CNS) Cardiovascular Obesity MASH/NASH

Requirements

Bachelor's degree required
Minimum 1 year of independent on-site monitoring experience in a CRO, biotech or pharmaceutical
Working knowledge of GCP, ICH, and clinical trial regulations.
Strong communication, organizational, and problem-solving skills.
Proficiency with Microsoft Office applications.

Nice To Haves

Experience in one or more of the following therapeutic areas: Central Nervous System (CNS) Cardiovascular Obesity MASH/NASH

Responsibilities

Conduct site selection, initiation, routine monitoring, and closeout visits in accordance with GCP, ICH, and applicable regulatory requirements.
Build strong relationships with investigative sites and provide protocol, process, and study-specific training.
Monitor study progress, including site activation, patient recruitment, enrollment, data collection, and query resolution.
Evaluate site performance and compliance, identifying risks and escalating quality concerns when appropriate.
Ensure study documentation, regulatory records, and Trial Master File (TMF) requirements are maintained accurately and are inspection-ready.
Prepare monitoring reports, follow-up communications, and other required study documentation.
Collaborate with cross-functional study teams to support successful project delivery and achieve study milestones.
Support patient recruitment and retention initiatives at the site level.
Assist with site financial and administrative activities, including invoice management, when applicable.