Senior Clinical Site Lead

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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  

Understand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with Abbott clinical staff, e.g. Site CRA, Site Contract Associate.  

Train facility staff regarding protocol requirements and technology.  

Enrollment  

Develop site-specific strategies to promote appropriate patient enrollment.  

Identify site successes and challenges and assist in implementing techniques that promote study goal achievement.  

Continuously evaluate site study performance and provide timely feedback to site.  

Attend study procedures and follow-ups when indicated (or ensure trained personnel attend).  

Regulatory and Quality  

Core level Abbott certification and/or equivalent level proficiency  

Develop site-specific strategies to avoid deviations.  

Educate site on tools to facilitate compliance.  

Provide timely feedback to the sites on key compliance indicators.  

Escalate non-compliant sites according to corporate policy.  

Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.  

Review data and source documentation from investigational sites for accuracy and completeness  

Facilitate resolution of data queries and action items at clinical sites  

Promptly reports the findings of monitoring visits according to Abbott processes.  

Maintain accurate, detailed and complete records of monitoring visit