Clinical Research Associate (CRA) | Contract

Clinical Research Associate (CRA) - Renal & Hepatic

Engagement Type: Contract (6 months to start, with potential for long-term extension)

Hours: Approximately 130 - 160 hours per month

Location: Remote; candidates must be based in the Central or Southeastern U.S. Preferred locations include Texas, Illinois (Chicago area), or Florida.

Travel: Approximately 6 - 10 days per month

Position Overview

Our client, a Contract Research Organization (CRO) specializing in Phase I and Phase II clinical studies, is seeking an experienced Clinical Research Associate (CRA) to support the successful execution of renal and hepatic clinical trials

The CRA will play a key role in ensuring participant safety, data integrity, and regulatory compliance throughout the clinical trial lifecycle. This individual will provide site support, conduct monitoring activities, and collaborate closely with cross-functional teams to drive efficient study execution and the achievement of trial objectives

Key Responsibilities

• Monitor multiple clinical trial sites to ensure compliance with study protocols, regulatory requirements, and ICH-GCP guidelines
• Conduct all phases of site monitoring, including Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs)
• Perform both on-site and remote monitoring activities to evaluate site performance, identify and resolve issues, and ensure high-quality study execution
• Review informed consent documentation and verify adherence to patient safety procedures
• Identify, document, and report Serious Adverse Events (SAEs) in accordance with sponsor and regulatory requirements
• Ensure accurate and timely data entry, source data verification, and query resolution within Electronic Data Capture (EDC) systems
• Collaborate with cross-functional teams, including Clinical Operations, Data Management, and Medical Affairs, to support study timelines and deliverables
• Maintain complete and accurate monitoring reports, regulatory documentation, and site records
• Provide training, guidance, and ongoing support to site personnel to ensure protocol compliance and adherence to clinical research best practices
• Build and maintain strong working relationships with investigators, study coordinators, and other key stakeholders
• Travel approximately 6-10 days per month to conduct on-site monitoring visits

Qualification

• Must be based in the Central or Southeastern United States; preferred locations include Texas, Illinois (Chicago area), or Florida
• Minimum of 5 years of independent clinical monitoring experience as a Clinical Research Associate (CRA)
• Experience monitoring renal and hepatic clinical trials is strongly preferred
• Strong knowledge of clinical trial processes, FDA regulations, ICH-GCP guidelines, and industry best practices
• Experience with Clinical Trial Management Systems (CTMS), Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC) platforms, electronic Trial Master Files (eTMF), and **Veeva Vault is highly preferred
• Proven ability to manage multiple clinical trial sites and priorities simultaneously in a fast-paced environment
• Strong organizational, analytical, and problem-solving skills with exceptional attention to detail
• Excellent written and verbal communication skills and the ability to collaborate effectively with cross-functional teams
• Ability and willingness to travel approximately 6-10 days per month; valid driver's license required