Description
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:
- Immunology/Gastroenterology (IM/GI)
- Dermatology
- Women's Health
- Asthma/Respiratory
- Ophthalmology
- HIV
Job Overview As a Clinical Research Associate II, you will conduct site selection, initiation, routine monitoring, and closeout visits in accordance with GCP, ICH, and applicable regulatory requirements.
Key responsibilities include:
- Building strong relationships with investigative sites and providing protocol, process, and study-specific training
- Monitoring study progress, including site activation, patient recruitment, enrollment, data collection, and query resolution
- Evaluating site performance and compliance, identifying risks and escalating quality concerns when appropriate
- Ensuring study documentation, regulatory records, and Trial Master File (TMF) requirements are maintained accurately and are inspection-ready
- Preparing monitoring reports, follow-up communications, and other required study documentation
- Collaborating with cross-functional study teams to support successful project delivery and achieve study milestones
- Supporting patient recruitment and retention initiatives at the site level
- Assisting with site financial and administrative activities, including invoice management, when applicable
Qualifications
- 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
The potential base pay range for this role, when annualized, is $74,500.00 - $197,500.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.