Clinical Research Associate 2, IQVIA

IQVIA; Durham (NC); Vor Ort; USD 75.000 - 198.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Clinical Research Associate II with independent on-site monitoring experience to join our team in the United States. You will conduct site selection, initiation, routine monitoring, and closeout visits in accordance with GCP, ICH, and applicable regulatory requirements while training site staff.

You will build strong investigator relationships, monitor progress, ensure TMF readiness, prepare monitoring reports, and collaborate with cross-functional teams to support patient

Qualifikationen

• 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.

Aufgaben

• Conduct site selection, initiation, routine monitoring, and closeout visits.
• Prepare monitoring reports, follow-up communications, and TMF documentation.
• Collaborate with cross-functional study teams to support project delivery and milestones.
• Support patient recruitment and retention initiatives at the site level.
• Assist with site financial and administrative activities, including invoice management.

Kenntnisse

GCP knowledge

ICH guidelines

Communication skills

Organizational skills

Problem-solving skills

MS Office proficiency

Ausbildung

Bachelor's degree

Tools

Microsoft Office

Jobbeschreibung

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

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.

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.

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.