Site Operations Specialist
hace 2 semanas
Job Overview
In this role, you will perform site management work to ensure that sites are conducting studies and reporting data as required by study protocols, regulations, and sponsor requirements.
Key Responsibilities
- Perform site monitoring visits (selection, initiation, monitoring, and close-out visits) in accordance with contracted scope of work and regulatory requirements.
- Work with sites to adapt and drive subject recruitment plans to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites.
- Evaluate the quality and integrity of study site practices related to protocol adherence and regulatory compliance.
- Manage study progress by tracking regulatory submissions, recruitment, enrollment, case report form completion, and data query generation and resolution.
- Ensure accurate documentation regarding site management, monitoring visit findings, and action plans.
Requirements
- Bachelor's Degree in a scientific discipline or healthcare preferred.
- At least 2 years of on-site monitoring experience.
- Familiarity with clinical research regulatory requirements (GCP and ICH guidelines).
- Good therapeutic and protocol knowledge.
- Excellent computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
- Strong written and verbal communication skills, with a good command of the English language.
- Effective time and financial management skills.
- Ability to establish effective working relationships with coworkers, managers, and clients.
The estimated salary for this role is $65,000 - $90,000 per year, depending on location and experience. This position requires frequent travel to site locations. We offer competitive benefits and a collaborative work environment. Join us at IQVIA and help create a healthier world.
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