Clinical Research Associate - Site Monitoring & Trials

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

Job summary

IQVIA is seeking a Monitoring Scientist to perform on-site monitoring for clinical studies in the United States. You will ensure sites conduct studies according to protocol, GCP and sponsor requirements, and support site recruitment and data quality.

Responsibilities include visits (initiation, monitoring, close-out), communication with sites, maintaining TMF/ISF, and generating visit reports. Strong English, organizational, and time-management skills are essential.

Qualifications

• Bachelors degree in scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• GCP and ICH regulatory knowledge.
• Proficient in Word, Excel and PowerPoint.
• Strong written and verbal English communication.
• Organizational and problem-solving skills.
• Ability to manage multiple sites and timelines.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out).
• Coordinate subject recruitment plan with sites to boost predictability.
• Administer protocol training and maintain regular site communication.
• Assess site practices for protocol compliance and regulatory adherence.
• Track regulatory submissions, recruitment, CRF completion and data queries.
• Maintain TMF and ISF, ensure site documents are filed appropriately.
• Create reports and letters; support project execution with study team.

Skills

On-site monitoring

Communication skills

Organizational skills

Problem solving

Time management

Financial management

Collaboration

Education

Bachelor's degree in scientific discipline or health care

Tools

MS Word

Excel

PowerPoint

Job description

IQVIA is seeking a Monitoring Scientist to perform on-site monitoring for clinical studies in the United States. You will ensure sites conduct studies according to protocol, GCP and sponsor requirements, and support site recruitment and data quality.

Responsibilities include visits (initiation, monitoring, close-out), communication with sites, maintaining TMF/ISF, and generating visit reports. Strong English, organizational, and time-management skills are essential.