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 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
• 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

• Bachelor's Degree Degree in scientific discipline or health care preferred

Benefits

• Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered.
• Dependent 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

• Requires at least 1.5 years of year 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
• 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 use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
• Written and verbal communication skills including good command of English language
• Organizational and problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• I.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Bachelor's Degree Degree in scientific discipline or health care preferred
• Requires at least 1.5 years of year of on-site monitoring experience.

Required skills

• Clinical Practice (GCP), Clinical Research Regulatory Requirements, International Conference on Harmonisation (ICH) Guidelines, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Relationship Management

Experience

• 1+ years