Site Monitoring CRA — Clinical Trials Expert

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

Job summary

IQVIA is seeking a Clinical Research Associate to perform monitoring visits and manage site performance in the United States. You will coordinate recruitment plans, train site staff, and ensure protocol compliance with GCP/ICH guidelines.

The role involves tracking regulatory submissions, managing data queries, and maintaining TMF/ISF documentation. Strong communication and organizational skills are essential for success in this position.

Qualifications

• Bachelor's degree in a scientific discipline or healthcare preferred.
• At least 2 years of on-site monitoring experience as a Clinical Research Associate (CRA) in a CRO, sponsor, or similar setting.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
• i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad.
• Experience utilizing EDC, CTMS, eTMF, IVRS/IWRS, and other clinical trial systems.

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 (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the ISF is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Skills

Communication skills

Organizational skills

Problem-solving

Time management

Financial management

Education

Bachelor's degree in scientific discipline or healthcare

Tools

EDC

CTMS

eTMF

IVRS/IWRS

Microsoft Word

Microsoft Excel

PowerPoint

Job description

IQVIA is seeking a Clinical Research Associate to perform monitoring visits and manage site performance in the United States. You will coordinate recruitment plans, train site staff, and ensure protocol compliance with GCP/ICH guidelines.

The role involves tracking regulatory submissions, managing data queries, and maintaining TMF/ISF documentation. Strong communication and organizational skills are essential for success in this position.