Sponsor-Dedicated CRA — On-Site Monitoring Expert

IQVIA; O'Fallon (IL); On-site; USD 72,000 - 189,000; Full time

Job summary

IQVIA is seeking a field-based Monitoring Professional to ensure sites conduct studies per protocol, regulations, and sponsor requirements. This role focuses on site visits, data quality, and cross-functional collaboration across study teams.

Responsibilities include coordinating recruitment plans, maintaining TMF/ISF documentation, and ensuring regulatory adherence while communicating findings and actions with sites and sponsors.

Qualifications

• Bachelor's degree in scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Knowledge of GCP and ICH guidelines.
• Proficient with MS Word, Excel and PowerPoint.
• Strong written and verbal English communication.

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 Investigator's Site File (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

GCP knowledge

ICH guidelines

English communication

Time management

Organizational skills

Regulatory compliance

Education

Bachelor's degree in scientific discipline or health care preferred

Tools

MS Office

Job description

IQVIA is seeking a field-based Monitoring Professional to ensure sites conduct studies per protocol, regulations, and sponsor requirements. This role focuses on site visits, data quality, and cross-functional collaboration across study teams.

Responsibilities include coordinating recruitment plans, maintaining TMF/ISF documentation, and ensuring regulatory adherence while communicating findings and actions with sites and sponsors.