Sponsor-Driven Clinical Research Associate

IQVIA; Elk Grove (CA); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking an on-site Clinical Research Monitor to ensure sites conduct studies per protocol and regulatory standards. You will perform visits, manage recruitment plans, administer protocol training, and escalate any quality issues to ensure data integrity.

Responsibilities include tracking submissions, enrollments, CRF completion, and data queries, plus maintaining TMF/ISF and collaborating with the study team for successful project execution.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines.
• Proficient in MS Word, Excel and PowerPoint; good communication in English.

Responsibilities

• Perform monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Coordinate recruitment plans with sites to support project needs.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate issues.
• Track regulatory submissions, approvals, recruitment, CRF completion, data queries.
• Maintain Trial Master File and Investigator's Site File per regulatory requirements.
• Create and maintain documentation from visits and action plans.
• Collaborate with study team for project execution support.
• Provide site-specific recruitment plan support and, if applicable, site financial management.

Skills

On-site monitoring

Communication skills

Organizational skills

Time management

Financial management

Team collaboration

English proficiency

Education

Bachelor's degree in scientific discipline or health care preferred

Tools

Microsoft Word

Excel

PowerPoint

Laptop & mobile device usage

Job description

IQVIA is seeking an on-site Clinical Research Monitor to ensure sites conduct studies per protocol and regulatory standards. You will perform visits, manage recruitment plans, administer protocol training, and escalate any quality issues to ensure data integrity.

Responsibilities include tracking submissions, enrollments, CRF completion, and data queries, plus maintaining TMF/ISF and collaborating with the study team for successful project execution.