Abbott

The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure) for the greater Atlanta region.. This new team member is a 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.. The Clinical Site Lead 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.. Note: this role is field based and requires the Clinical Site Lead to be based in the Atlanta, GA region.. Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel.

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 114,000 colleagues serve people in more than 160 countries.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youll also have access to:<ul><li>Career development with an international company where you can grow the career you dream of.</li></ul><ul><li>Free medical coverage for employees* via the Health Investment Plan (HIP) PPO</li></ul><ul><li>An excellent retirement savings plan with high employer contribution</li></ul><ul><li>Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelors degree.</li></ul><ul><li>A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.</li></ul><ul><li>A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.</li></ul>For years, Abbotts medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether its glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks.The OpportunityThe Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure) for the greater Atlanta region. This new team member is a 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.This individual will adhere to specified site nomination, qualification, and startup processes as well as lead ongoing training/retraining of all site stakeholders to ensure protocol adherence. Continuously reviews, manages, and influences all aspects of sites recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). Additionally, will proactively utilize appropriate operational metrics to minimize screen failure, attrition rate, etc. and will monitor to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits. The Clinical Site Lead 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.Note: this role is field based and requires the Clinical Site Lead to be based in the Atlanta, GA region.What Youll Work OnWith limited direction from leadership:Develop and maintain a productive clinical territory:<ul><li>Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels and required data quality.</li></ul><ul><li>Understand and assess investigators interests and qualifications.</li></ul><ul><li>Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.</li></ul><ul><li>Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel.</li></ul><ul><li>Provide ongoing technical support to customers and field staff.</li></ul><ul><li>Facilitate communication between clinical sites and other Abbott clinical staff (e.g., operations management, study team, Site Contracts Associate), as needed.</li></ul>Manage all aspects of study lifecycle to include site regulatory and quality:<ul><li>Start Up</li></ul><ul><li>Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.</li></ul><ul><li>Facilitate all aspects of the start-up process and site initiation visits</li></ul><ul><li>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.</li></ul><ul><li>Train facility staff regarding protocol requirements and technology.</li></ul><ul><li>Enrollment</li></ul><ul><li>Develop site-specific strategies to promote appropriate patient enrollment.</li></ul><ul><li>Identify site successes and challenges and assist in implementing techniques that promote study goal achievement.</li></ul><ul><li>Continuously evaluate site study performance and provide timely feedback to site.</li></ul><ul><li>Attend study procedures and follow-ups when indicated (or ensure trained personnel attend).</li></ul><ul><li>Regulatory and Quality</li></ul><ul><li>Core level Abbott certification and/or equivalent level proficiency</li></ul><ul><li>Develop site-specific strategies to avoid deviations.</li></ul><ul><li>Educate site on tools to facilitate compliance.</li></ul><ul><li>Provide timely feedback to the sites on key compliance indicators.</li></ul><ul><li>Escalate non-compliant sites according to corporate policy.</li></ul><ul><li>Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations.</li></ul><ul><li>Review data and source documentation from investigational sites for accuracy and completeness</li></ul><ul><li>Facilitate resolution of data queries and action items at clinical sites</li></ul><ul><li>Promptly reports the findings of monitoring visits according to Abbott processes.</li></ul><ul><li>Maintain accurate, detailed and complete records of monitoring visits.</li></ul>Provide training and procedure coverage:<ul><li>Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches.</li></ul><ul><li>As needed, provide clinical and technical expertise for clinical trial procedure support</li></ul><ul><li>Attend study procedures and follow-ups (or ensure trained personnel attend).</li></ul>Collaborate with commercial partners:<ul><li>When appropriate, collaborate in the education of local sales groups on new product launches.</li></ul><ul><li>When appropriate, contribute to the education of customers on new and existing Abbott products.</li></ul><ul><li>Meet with key customers where Abbott GCO presence can elevate the customer experience.</li></ul><ul><li>Act as an additional resource for technical questions and troubleshooting.</li></ul>Identify and adapt to shifting priorities and competing demands.Remain current on developments in the field of expertise including clinical and Abbott product knowledge, competitive positioning and published scientific and economic evidence.<ul><li>Maintain at least one area of expertise and function as a local clinical and technical resource.</li></ul><ul><li>Develop working knowledge of disease states and product lines for all relevant Abbott clinical trials.</li></ul><ul><li>Upon leadership approval, complete and maintain certifications that are relevant to specific field(s) of expertise (where appropriate).</li></ul>Possess independent problem-solving skills and ability to make decisions. Exhibit excellent oral and written communication skills.Required Qualifications<ul><li>Bachelors Degree OR an equivalent combination of education or work experience.</li></ul><ul><li>Minimum 2 years of related work experience</li></ul><ul><li>Strong clinical orientation, experience with products for use in interventional cardiology</li></ul><ul><li>Good working knowledge and application of business concepts, procedures and practices.</li></ul><ul><li>Will perform this role in a quality system environment.</li></ul><ul><li>Applies learned concepts and company policies and procedures in a safe and professional manner.</li></ul><ul><li>Has understanding and ability to perform clinical trial process including monitoring or regulating compliance and application of statistical reporting.</li></ul><ul><li>Must have excellent interpersonal, written, verbal and presentation skills.</li></ul><ul><li>Must be able to work effectively independently and within a group.</li></ul>Preferred Qualifications<ul><li>Bachelors Degree in Life Sciences, Engineering or medical training (RN, EMT, PA, etc)</li></ul><ul><li>Experience working in the medical industry</li></ul><ul><li>2 years of progressively more responsible relevant clinical trial experience in the cardiovascular field.</li></ul><ul><li>Competency in catheterization lab and operating room protocol and procedures.</li></ul><ul><li>Highly developed interpersonal skills, and strong attention to detail.</li></ul>Apply Now (https://www.jobs.abbott/us/en)<ul><li>Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.</li></ul>Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.The base pay for this position is $57,300.00 $114,700.00. In specific locations, the pay range may vary from the range posted.An Equal Opportunity EmployerAbbot welcomes and encourages diversity in our workforce.We provide reasonable accommodation to qualified individuals with disabilities.To request accommodation, please call 224-667-4913 or email corpjat@abbott.com <h3>J-18808-Ljbffr</h3>

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