Senior Clinical Research Associate: Site Monitoring & Trials

IQVIA Inc; Denver (CO); On-site; USD 90,000 - 150,000; Full time

Job summary

IQVIA MedTech's MCRA unit seeks a Clinical Monitoring professional to perform site monitoring and site management to ensure studies are conducted per protocol, GCP/ICH guidelines, and sponsor requirements.

This on-site role in the Denver area partners with sites, manages recruitment, training, data quality, and TMF/ISF compliance, and collaborates with the study team to keep projects on track.

Qualifications

• Bachelor's Degree or higher in a scientific discipline or health care (req).
• At least 1 year of on-site monitoring experience (req).
• Equivalent combination of education, training and experience may be accepted (req).
• Knowledge of Good Clinical Practice (GCP) and ICH guidelines (req).
• Therapeutic and protocol knowledge from company training.
• Proficiency with MS Word, Excel, PowerPoint; laptop and mobile devices as applicable.
• Strong written and verbal English communication skills.
• Excellent organizational and problem-solving abilities.
• Good time and financial management; ability to work with coworkers, managers and clients.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and regulatory requirements (GCP/ICH).
• Coordinate recruitment plans with sites to support project needs.
• Administer protocol training to sites and maintain regular communication with site personnel.
• Evaluate site practices for protocol adherence and regulatory compliance; escalate issues.
• Track regulatory submissions, recruitment, CRF completion, data queries; support start-up as needed.
• Maintain TMF/ISF documents and ensure proper filing and retention.

Skills

On-site monitoring experience

GCP/ICH knowledge

Communication skills

Organizational skills

Time management

Financial management

Relationship building

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

IQVIA MedTech's MCRA unit seeks a Clinical Monitoring professional to perform site monitoring and site management to ensure studies are conducted per protocol, GCP/ICH guidelines, and sponsor requirements.

This on-site role in the Denver area partners with sites, manages recruitment, training, data quality, and TMF/ISF compliance, and collaborates with the study team to keep projects on track.