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Illinois workNet
Sr. Clinical Site Lead- Philadelphia, PA
Career Insights for Clinical Supervisor / Manager
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What they do
A Clinical Supervisor or Manager supervises staff and manages services in a clinical program. May provide clinical supervision for nursing, counseling or home health care staff. Works to ensure quality patient care. Trains and develops clinical staff and manages clinical program budgets.
$105,450 / year median in Illinois
+12% projected growth
Job Description
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 122,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 (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 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 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. What You'll Work On With limited direction from leadership: 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 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 visits.