Senior Clinical Research Associate I — Drive Site Excellence

IQVIA Inc; Carlsbad (CA); On-site; USD 90,000 - 175,000; Full time

Job summary

IQVIA is seeking a Senior Clinical Research Associate 1 to manage site monitoring and coordination across assigned sites in the United States. The role emphasizes ensuring protocol compliance, regulatory adherence, and effective site performance through monitoring visits and training.

The candidate will track regulatory submissions, site recruitment, data queries, and documentation while collaborating with cross-functional teams to support study execution and startup activities.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Good knowledge of clinical research regulatory requirements (GCP/ICH).
• Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope of work and GCP.
• Drive and track subject recruitment plans to enhance study predictability.
• Administer protocol training to sites and maintain regular communications.
• Evaluate site practices for protocol adherence and regulatory compliance; escalate issues as needed.
• Manage study progress: regulatory submissions, recruitment, CRF completion and data queries; may support startup.
• Maintain TMF/ISF documentation; ensure required filings.
• Collaborate with study team for project execution support.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate. Responsibilities Essential Functions
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Skills

On-site monitoring experience

GCP & ICH guidelines

Regulatory knowledge

Regulatory requirements

Site management

Education

Bachelor's Degree in scientific discipline or health care

Job description

IQVIA is seeking a Senior Clinical Research Associate 1 to manage site monitoring and coordination across assigned sites in the United States. The role emphasizes ensuring protocol compliance, regulatory adherence, and effective site performance through monitoring visits and training.

The candidate will track regulatory submissions, site recruitment, data queries, and documentation while collaborating with cross-functional teams to support study execution and startup activities.