Sponsor-Dedicated Clinical Research Associate

IQVIA; Clarksville (TN); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking a qualified professional to monitor study sites and manage site activities in accordance with the protocol, GCP, and local regulations. The role ensures data integrity, recruitment progress, and regulatory submissions across multiple sites.

The ideal candidate will have a science or health care degree, at least two years of on-site monitoring experience, and strong English communication and organizational skills.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (GCP/ICH).
• Proficient in Microsoft Word, Excel and PowerPoint; comfortable with laptop and mobile devices.
• Written and verbal communication skills including good command of English.
• Strong organizational and problem-solving skills.
• Effective time and financial management 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 visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals site documents are available for filing in the TMF and verify ISF maintenance per GCP and local requirements.
• Create and maintain documentation regarding site management, monitoring visit findings and action plans with visit reports and follow-up letters.
• Collaborate with study team members for project execution support as appropriate.
• May be accountable for developing project subject recruitment plan per site.
• May be accountable for site financial management according to contract and retrieve invoices per local requirement.

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Excel

PowerPoint

Job description

IQVIA is seeking a qualified professional to monitor study sites and manage site activities in accordance with the protocol, GCP, and local regulations. The role ensures data integrity, recruitment progress, and regulatory submissions across multiple sites.

The ideal candidate will have a science or health care degree, at least two years of on-site monitoring experience, and strong English communication and organizational skills.