Sponsor-Driven Clinical Research Associate

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

Job summary

IQVIA is seeking a Clinical Monitor to perform on-site monitoring and site management across studies in the United States. You will ensure sites conduct studies per protocol, maintain data integrity, and comply with GCP/ICH guidelines.

The role requires collaboration with investigators, site staff, and the study team, plus effective communication and documentation of monitoring findings and actions.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of applicable clinical research regulatory requirements (GCP/ICH).
• Proficiency in Microsoft Word, Excel and PowerPoint; laptop, iPhone/iPad usage as applicable.
• Strong written and verbal communication in English; good organizational and problem-solving skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with scope of work and GCP.
• Collaborate with sites to drive and track subject recruitment to enhance study predictability.
• Administer protocol training to sites and maintain regular communication about project expectations and issues.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate as needed.
• Track regulatory submissions, recruitment, CRF completion, data query resolution; support start-up.
• Maintain TMF/ISF; ensure site documents are filed as required.

Skills

On-site monitoring

GCP/ICH knowledge

English communication

Time management

Financial management

Organizational skills

Problem-solving

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Excel

PowerPoint

Job description

IQVIA is seeking a Clinical Monitor to perform on-site monitoring and site management across studies in the United States. You will ensure sites conduct studies per protocol, maintain data integrity, and comply with GCP/ICH guidelines.

The role requires collaboration with investigators, site staff, and the study team, plus effective communication and documentation of monitoring findings and actions.