Clinical Research Associate: Site Monitoring & Study Oversight

IQVIA; Springfield (OH); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking an experienced Clinical Research Associate to monitor study sites and ensure data integrity in line with the protocol, regulations, and sponsor requirements. The role requires engaging with sites to drive recruitment plans, administer protocol training, and maintain clear communications throughout the study lifecycle.

The ideal candidate has 2+ years of on-site CRA experience, strong knowledge of GCP/ICH guidelines, and proficiency with EDC, CTMS, and eTMF systems, alongside

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 2 years of independent on-site monitoring experience as a Clinical Research Associate (CRA).
• Equivalent combination of education, training and experience may be accepted.
• Knowledge of GCP and ICH guidelines.
• Experience using EDC, CTMS, eTMF, IVRS/IWRS and other clinical trial systems.
• Written and verbal communication skills in English.
• Strong organizational, problem-solving and time management skills.
• Ability to collaborate with study team members and clients.

Responsibilities

• Perform site monitoring visits (initiation, monitoring and close-out) per scope of work and GCP.
• Drive subject recruitment plans to enhance predictability.
• Administer protocol training and maintain regular site communication.
• Evaluate site practices for protocol conduct and regulatory adherence.
• Track submissions, recruitment, CRF completion and data queries; may support start-up.
• Maintain TMF/ISF documentation per regulatory requirements.
• Document site management activities and create visit reports and action letters.
• Collaborate with study team for project execution support.
• Support site recruitment plan development per site if applicable.
• Support site financial management per contract and invoice retrieval if applicable.

Skills

Communication skills

Time management

Organizational skills

Problem-solving

Team collaboration

Education

Bachelor's degree

Tools

EDC

CTMS

eTMF

IVRS/IWRS

Microsoft Word

Excel

PowerPoint

Job description

IQVIA is seeking an experienced Clinical Research Associate to monitor study sites and ensure data integrity in line with the protocol, regulations, and sponsor requirements. The role requires engaging with sites to drive recruitment plans, administer protocol training, and maintain clear communications throughout the study lifecycle.

The ideal candidate has 2+ years of on-site CRA experience, strong knowledge of GCP/ICH guidelines, and proficiency with EDC, CTMS, and eTMF systems, alongside