Clinical Research Associate 2, IQVIA

IQVIA; Durham (NC); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate II with independent on-site monitoring experience to join our team in Durham, NC. You will conduct site visits, ensure GCP/ICH compliance, train site staff, manage TMF, monitor progress, and collaborate with cross-functional teams to deliver study milestones and support patient recruitment.

Ideal candidates have a Bachelor's degree and at least 1 year of monitoring experience, with strong communication and organizational skills and proficiency in

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.

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 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.

Skills

Communication skills

Organizational skills

Problem solving

Education

Bachelor's degree

Tools

Microsoft Office

Job 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

• 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.

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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.