Sponsor-Centric Clinical Research Associate

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

Job summary

IQVIA is seeking a field-based professional to perform monitoring and site management to ensure sites conduct studies per protocol and regulatory requirements. You will work with sites to drive recruitment plans and maintain open lines of communication with stakeholders.

Applicants should have a Bachelor’s degree in a scientific field and at least 2 years of on-site monitoring experience, with strong GCP/ICH knowledge and excellent organizational abilities.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Strong knowledge of GCP and ICH guidelines.
• Good communication and organizational skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP.
• Collaborate with sites to adapt and track recruitment plans to improve predictability.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, and data queries.
• Ensure TMF/ISF documentation is maintained per regulatory requirements.
• Prepare visit reports, follow-up letters, and other study documents.
• Coordinate with study team for project execution support.
• May support startup activities and site financial management if applicable.

Skills

Site monitoring

GCP/ICH knowledge

Communication

English proficiency

Time management

Education

Bachelor's Degree in Life Sciences or related field

Tools

MS Word

Excel

PowerPoint

Job description

IQVIA is seeking a field-based professional to perform monitoring and site management to ensure sites conduct studies per protocol and regulatory requirements. You will work with sites to drive recruitment plans and maintain open lines of communication with stakeholders.

Applicants should have a Bachelor’s degree in a scientific field and at least 2 years of on-site monitoring experience, with strong GCP/ICH knowledge and excellent organizational abilities.