Senior Clinical Research Associate I — Site Monitoring Pro

IQVIA; Overland Park (KS); On-site; USD 90,000 - 175,000; Full time

Job summary

IQVIA is hiring Senior Clinical Research Associate 1 with experience across multiple therapeutic areas to monitor and manage trial sites, ensuring protocol adherence and data integrity. The role emphasizes on-site monitoring, regulatory tracking, and collaboration with study teams in a global clinical research environment.

The position involves training sites, coordinating with investigators, and maintaining essential TMF/ISF documentation, with potential involvement in start-up activities and

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of on-site monitoring experience.
• 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.
• Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Good therapeutic and protocol knowledge as provided in company training.

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, case report form (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. Responsibilities Essential Functions
• 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

Regulatory knowledge

GCP & ICH guidelines

Clinical oversight

Education

Bachelor's Degree in scientific discipline or health care preferred

Job description

IQVIA is hiring Senior Clinical Research Associate 1 with experience across multiple therapeutic areas to monitor and manage trial sites, ensuring protocol adherence and data integrity. The role emphasizes on-site monitoring, regulatory tracking, and collaboration with study teams in a global clinical research environment.

The position involves training sites, coordinating with investigators, and maintaining essential TMF/ISF documentation, with potential involvement in start-up activities and