Description
Join IQVIA UK's Site Management team as a Senior CRA to build a meaningful career, drive real impact, and continue your professional growth.
Perform monitoring and site management work to ensure sites are conducting studies and reporting data as required by the study protocol, regulations, guidelines, and sponsor requirements.
Essential Functions
- Conduct site monitoring visits (selection, initiation, monitoring, and close-out) in accordance with contracted scope of work and Good Clinical Practice.
- Collaborate with sites to adapt, drive, and track subject recruitment plans to enhance predictability.
- Provide protocol and study-related training to assigned sites and establish regular communication to manage project expectations and issues.
- Evaluate study site practices for quality and integrity, escalating issues as needed.
- Manage study progress by tracking regulatory submissions, recruitment, case report form completion, and data query resolution.
- Ensure site documents are available for filing in the Trial Master File and verify Investigator's Site File maintenance.
- Create and maintain documentation regarding site management, monitoring visit findings, and action plans.
- Collaborate with study team members for project execution support.
Qualifications
- Bachelor's degree in a scientific discipline or healthcare.
- At least 2 years of on-site monitoring experience.
- Good knowledge of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Proficiency in Microsoft Word, Excel, and PowerPoint, and use of a laptop computer and iPhone/iPad.
- Excellent written and verbal communication skills, with a good command of English.
- Strong organizational, problem-solving, time, and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
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