Clinical Research Associate: Site Monitoring & Coordination

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

Job summary

IQVIA is seeking an on-site Clinical Research Associate (CRA) to monitor study sites, ensure protocol compliance, and support data integrity. The role requires coordinating with sites, managing recruitment plans, and maintaining regulatory documentation in line with GCP and ICH guidelines.

The candidate should have at least 2 years of independent on-site CRA experience, strong English communication, and proficiency with EDC/CTMS/eTMF/IVRS/IWRS.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 2 years of independent on-site monitoring experience as a CRA in a CRO, sponsor, or similar setting.
• Good knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Experience utilizing EDC, CTMS, eTMF, IVRS/IWRS, and other clinical trial systems.
• Proficiency with Microsoft Word, Excel and PowerPoint; comfortable with laptop, iPhone and iPad where applicable.
• Strong written and verbal English communication skills.
• Organizational and problem-solving skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Drive subject recruitment plans to align with project needs and improve predictability.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion and data queries; support start-up when needed.
• Maintain TMF/ISF documentation and site files per regulatory requirements.
• Collaborate with study team for project execution and site support.
• Assist in developing recruitment plans per site and, where applicable, site financial management.

Skills

English communication

Time management

Interpersonal skills

Problem solving

Education

Bachelor's degree in scientific discipline or health care

Equivalent combination of education, training and experience

Tools

EDC

CTMS

eTMF

IVRS/IWRS

Microsoft Office

Job description

IQVIA is seeking an on-site Clinical Research Associate (CRA) to monitor study sites, ensure protocol compliance, and support data integrity. The role requires coordinating with sites, managing recruitment plans, and maintaining regulatory documentation in line with GCP and ICH guidelines.

The candidate should have at least 2 years of independent on-site CRA experience, strong English communication, and proficiency with EDC/CTMS/eTMF/IVRS/IWRS.