Sponsor-Dedicated Clinical Research Associate

IQVIA; Springfield (OH); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking a site monitoring professional to ensure study sites conduct and report data per protocol, GCP, and sponsor requirements. Responsibilities include monitoring visits, training, TMF/ISF oversight, and collaboration with the study team.

Requirements include a bachelor's in a scientific field, at least 2 years on-site monitoring experience, and strong regulatory knowledge along with proficiency in MS Word/Excel/PowerPoint and excellent English communication.

Qualifications

• Bachelor's degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• Good knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Proficiency in Microsoft Word, Excel and PowerPoint; laptop/iPhone/iPad usage.
• Written and verbal communication skills in English.
• Organizational and problem-solving abilities.

Responsibilities

• 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 and study training; maintain regular communication with sites.
• Evaluate site practices for protocol conduct and regulatory compliance; escalate issues.
• Track regulatory submissions, recruitment, CRF completion, data queries; support startup.
• Maintain TMF docs and ISF per regulatory requirements.
• Create documentation of site management, visit findings, and action plans.
• Collaborate with study team members for project execution support.
• Support development of recruitment plans per site; possibly site financial management.

Skills

On-site monitoring

GCP/ICH knowledge

Regulatory knowledge

English proficiency

Time management

Communication skills

Education

Bachelor's degree in science/healthcare

Tools

Microsoft Word

Microsoft Excel

PowerPoint

iPhone/iPad familiarity

Job description

IQVIA is seeking a site monitoring professional to ensure study sites conduct and report data per protocol, GCP, and sponsor requirements. Responsibilities include monitoring visits, training, TMF/ISF oversight, and collaboration with the study team.

Requirements include a bachelor's in a scientific field, at least 2 years on-site monitoring experience, and strong regulatory knowledge along with proficiency in MS Word/Excel/PowerPoint and excellent English communication.