Clinical Site Lead

Summary  

The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). Recognized resource in protocol execution, increasing product and disease state knowledge, procedure support (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application.  

Adheres to specified site nomination, qualification, and startup processes. Leads ongoing training/retraining of all site stakeholders to ensure protocol adherence. Continuously reviews, manages, and influences all aspects of site’s recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). Proactively utilizes appropriate operational metrics to minimize screen failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.  

May be consulted in the following areas: study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee.  

Main Responsibilities  

With limited direction from leadership:  

1. Develop and maintain a productive clinical territory:  

Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels and required data quality.  

Understand and assess investigators’ interests and qualifications.  

Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.  

Maintain open communication and relationships with key site personnel including the Principle Investigator, Research Coordinator, as well as regulatory and legal personnel.  

Provide ongoing technical support to customers and field staff.  

Facilitate communication between clinical sites and other Abbott clinical staff (e.g., operations management, study team, Site Contracts Associate), as needed.  

2. Manage all aspects of study lifecycle to include site regulatory and quality:  

Start Up  

Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.  

Facilitate all aspects of the start-up process and site initiation visits