Clinical Research Associate: On-Site Monitoring & Coordination

IQVIA Inc; Denver (CO); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate to monitor study sites, ensure data integrity, and drive subject recruitment plans in line with the protocol and regulatory standards. The role requires on-site visits, strong communication with sites, and collaboration with the study team to manage expectations and issues.

You will ensure TMF/ISF readiness, track regulatory submissions, and support start-up activities where needed.

Qualifications

• Bachelor's degree in science or healthcare preferred.
• At least 2 years' on-site monitoring experience as CRA.
• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Proficient with MS Word, Excel and PowerPoint; strong communication.

Responsibilities

• Perform site monitoring visits per scope of work and GCP.
• Coordinate recruitment plans to improve predictability.
• Administer protocol training and maintain site communication.
• Evaluate site practices for protocol adherence and quality.
• Track regulatory submissions, approvals, and CRF data queries.
• Maintain TMF/ISF documentation per regulatory requirements.
• Document visit findings and issue follow-up actions.
• Collaborate with study team for project execution.
• Support recruitment plan development per site, if applicable.

Skills

Attention to detail

Communication skills

Time management

Problem solving

English proficiency

Education

Bachelor's Degree in scientific discipline or health care

Tools

EDC

CTMS

eTMF

IVRS/IWRS

Microsoft Word

Excel

PowerPoint

Job description

IQVIA is seeking a Clinical Research Associate to monitor study sites, ensure data integrity, and drive subject recruitment plans in line with the protocol and regulatory standards. The role requires on-site visits, strong communication with sites, and collaboration with the study team to manage expectations and issues.

You will ensure TMF/ISF readiness, track regulatory submissions, and support start-up activities where needed.