Associate Clinical Site Lead - Atlanta

About this role

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: About Abbott  

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health.   We’re   always looking towards the future,   anticipating   changes in medical science and technology.  

Working at Abbott  

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.   You’ll   also have access to:  

• Career development with an international company where you can grow the career you dream of.  

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.  

• An excellent retirement savings plan with a high employer contribution  

• Tuition reimbursement, the Freedom 2 Save student debt program, and   FreeU   education benefit - an affordable and convenient path to getting a bachelor’s degree.  

• A company recognized as   a great place   to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.  

• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.  

The Opportunity  

The   Associate Clinical Site Lead   for the  Atlanta, GA   region drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). Developing skills and foundation to become a resource in protocol execution, developing 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.  

What You'll Work On  

With supervision of senior colleague/manager (or delegate):  

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.  

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  

• Strong understanding of GCP and commitment to progress knowledge and achieve Abbott certifications  

• 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 visits.  

Provide training and procedure coverage:   

• Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches.  

• As needed, provide clinical and technical   expertise   for cli

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