Clinical Research Associate - Site Monitoring & Study Execution

IQVIA; Kansas City (MO); In loco; USD 75.000 - 198.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Clinical Research Associate to monitor trial sites and ensure data integrity in line with the study protocol and ICH/GCP guidelines. The role involves initiating and close-out visits, site training, and ongoing communication with investigators to manage expectations and issues.

You will track regulatory submissions, patient recruitment, and data queries, while ensuring Study Files are complete and compliant.

Competenze

• Requires at least 2 years of independent on-site monitoring experience as a CRA.
• Bachelor's Degree in scientific discipline or health care preferred.
• Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Proficient in Microsoft Word, Excel and PowerPoint; comfortable with laptops/tablets.
• Experience using EDC, CTMS, eTMF and IVRS/IWRS for monitoring activities.
• Strong written and verbal English communications.
• Good organizational and problem-solving abilities.
• Ability to manage time and financial resources and work with teams.

Mansioni

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Collaborate with sites to drive recruitment plans to enhance predictability.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate issues as needed.
• Track regulatory submissions, enrollment, CRF completion, data queries; support startup as needed.
• Ensure TMF/ISF documentation is maintained per regulatory requirements.
• Document site management findings and action plans; generate visit reports and follow-up letters.
• Coordinate with study team for project execution support.

Conoscenze

On-site monitoring

Regulatory knowledge

Communication skills

Time/financial management

Team collaboration

English proficiency

Formazione

Bachelor's degree in science/healthcare

Equivalent combination of education/experience

Strumenti

EDC

CTMS

eTMF

IVRS/IWRS

MS Office (Word/Excel/PowerPoint)

Descrizione del lavoro

IQVIA is seeking a Clinical Research Associate to monitor trial sites and ensure data integrity in line with the study protocol and ICH/GCP guidelines. The role involves initiating and close-out visits, site training, and ongoing communication with investigators to manage expectations and issues.

You will track regulatory submissions, patient recruitment, and data queries, while ensuring Study Files are complete and compliant.