Sponsor-Dedicated Clinical Research Associate

IQVIA; Springfield (MO); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA in the United States is seeking an on-site site-monitoring professional to ensure study sites conduct the protocol and report data per GCP, ICH and sponsor requirements. You will perform monitoring visits, support site recruitment plans, train staff, and maintain essential study documentation.

Responsibilities include evaluating site practices for protocol adherence, tracking submissions and data queries, and collaborating with the study team to support project execution and startup

Qualifications

• Bachelor's degree in scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines.
• Strong written and verbal English communication.
• Proficiency with MS Word, Excel and PowerPoint.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with scope of work and GCP.
• Work with sites to adapt and track subject recruitment plans to enhance predictability.
• Administer protocol training to assigned sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion and data query resolution; may support start-up.
• Maintain TMF/ISF documentation and generate site visit reports and action letters.
• Collaborate with study team members for project execution support.

Skills

On-site monitoring

GCP/ICH knowledge

Regulatory compliance

Communication skills

Time and financial management

Site management

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

iPhone/iPad usage

Job description

IQVIA in the United States is seeking an on-site site-monitoring professional to ensure study sites conduct the protocol and report data per GCP, ICH and sponsor requirements. You will perform monitoring visits, support site recruitment plans, train staff, and maintain essential study documentation.

Responsibilities include evaluating site practices for protocol adherence, tracking submissions and data queries, and collaborating with the study team to support project execution and startup