Clinical Research Associate, Sponsor Dedicated

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• 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) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH 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

Preferred

• Knowledge of electronic data capture preferred

Benefits

• Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered.
• Depending on the position offered, a range of health and welfare and/or other benefits may be offered.
• Glassdoor
• 3.9
• IQVIA provides analytics, compliance, and management solutions to the life sciences industry.
• Durham, North Carolina, USA
• https://www.iqvia.com
• Public Company
• Total Funding
• $6.61B
• 2026-09-09
• Post Ipo Debt· $2B
• 2026-06-04
• Post Ipo Debt· $1.11B
• 2025-06-02
• Leadership Team
• Karl Guenault
• SVP and Chief Information Officer
• Chris Colapietro
• Vice President, Customer Engagement
• Recent News
• FierceBiotech
• Aligning drug discovery around patient benefit from the outset: Connecting human insights to better decisions
• 2026-10-20
• PR Newswire UK
• IQVIA Selects Veeva Clinical Operations Applications
• 2026-10-16
• IQVIA, Veeva expand on existing partnership for speedier clinical trials
• Company data provided by
• AI Tools

Qualifications

• 2.5 years of clinical research coordination experience at site level
• Nursing or University Degree (US Bachelor Level or equivalent) in one of the life sciences
• Equivalent combination of education, training and experience
• Knowledge of electronic data capture preferred

Required skills

• Clinical Research Coordination, Electronic Data Capture (EDC)

Preferred skills

• Knowledge of electronic data capture preferred

Experience

• 2+ years