Clinical Research Associate 2 (CRA II) – IQVIA
Location: Durham, North Carolina (Field-Based Role)
Job Type: Full-Time
Job ID: R1492365
IQVIA is seeking an experienced Clinical Research Associate 2 (CRA II) with hands-on, on-site monitoring experience in GLP-1, Obesity, Type II Diabetes, or Cardiovascular clinical trials. Experience in Phase I studies is considered an advantage.
This position offers the opportunity to work with global clinical research teams, support high-impact studies, and ensure adherence to regulatory and study-specific guidelines.
Job Overview
The Clinical Research Associate 2 will be responsible for comprehensive site monitoring and site management activities. The role ensures that assigned clinical trial sites conduct studies in accordance with study protocols, regulatory requirements, Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) guidelines.
Key Responsibilities
Conduct site visits including selection, initiation, routine monitoring, and close-out in alignment with project scope and regulatory requirements.
Support clinical sites in implementing and tracking subject recruitment plans to meet project timelines.
Provide protocol and study-related training to site personnel and maintain consistent communication for project updates and issue resolution.
Assess site practices to verify protocol compliance, data integrity, and adherence to relevant regulations. Escalate issues when needed.
Manage study progress including regulatory submissions, approvals, patient recruitment, CRF completion, and data query resolution.
Verify that essential documents are maintained in the Trial Master File (TMF) and Investigator Site File (ISF) as per regulatory standards.
Prepare timely and accurate monitoring visit reports, follow-up letters, and other study documentation.
Collaborate closely with internal clinical operations teams to support overall project execution.
Support development of site-level recruitment strategies when required.
Manage site-related financial activities in alignment with clinical trial agreements (if applicable).
Qualifications and Experience Required
Bachelor’s degree in a scientific or healthcare-related field (required).
Minimum 1 year of on-site monitoring experience in clinical research (required).
Experience in GLP-1, Obesity, Type II Diabetes, Cardiovascular studies, or Phase I trials preferred.
Strong knowledge of GCP, ICH guidelines, and clinical trial regulatory frameworks.
Proficiency in Microsoft Word, PowerPoint, Excel, and commonly used digital tools.
Excellent written and spoken communication skills.
Strong organizational, time management, and problem-solving abilities.
Ability to build and maintain professional working relationships with sites, colleagues, and clients.
About IQVIA
IQVIA is a global leader in advanced analytics, clinical research, and technology solutions for the life sciences industry. The organization supports the development and commercialization of innovative healthcare solutions to enhance patient outcomes and public health.
Compensation
The estimated annual base salary range for this position is USD 57,500 to USD 226,800.
Actual compensation may vary based on experience, qualifications, geographic location, and work schedule. Additional incentives, bonuses, and benefits may be offered depending on the role.
Equal Opportunity Statement
IQVIA is an equal opportunity employer. All applicants will receive consideration for employment without discrimination based on race, color, religion, gender, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic.
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