Job Details

JOB DESCRIPTIONAbbott 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.SummaryThe 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 earlyindicationof trends, clinical trial enrollment, and ICH-GCP and clinical researchapplication.Adheres to specified site nomination, qualification, and startup processes. Leads ongoing training/retraining of all site stakeholders to ensure protocol adherence.Continuouslyreviews, manages, and influences all aspects ofsite'srecruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). Proactivelyutilizesappropriate operationalmetrics 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 ResponsibilitiesWith limited direction from leadership:1. Develop andmaintaina productive clinical territory:Identify, develop, andmaintainsites capable of delivering start-up goals, study participationlevelsandrequireddata quality.Understand and assess investigators' interests and qualifications.Identifyappropriate investigatorsas defined by study-specific requirements and by the applicable regulatory code.Maintainopen communication and relationships with key site personnel including thePrincipleInvestigator, Research Coordinator, as well as regulatory and legal personnel.Provide ongoing technical support to customers and field staff.Facilitatecommunication 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 UpNominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.Facilitate all aspects of the start-up process and site initiation visitsUnderstand regulatory and legal requirements for study participation at a level that allows forappropriate collaborationwith Abbott clinical staff,e.g.Site CRA, Site Contract Associate.Train facility staffregardingprotocol requirements and technology.EnrollmentDevelopsite-specific strategies to promoteappropriate patientenrollment.Identifysite successes and challenges andassistin implementing techniques that promote study goal achievement.Continuously evaluatesite study performance and providetimelyfeedback to site.Attendstudy procedures and follow-ups whenindicated(or ensure trained personnelattend).Regulatory and QualityCore level Abbott certification and/or equivalent levelproficiencyDevelopsite-specific strategies to avoid deviations.Educatesite ontools tofacilitatecompliance.Providetimelyfeedback to the sites on key compliance indicators.Escalate non-compliant sites according to corporate policy.Collectessential documents,identifyand obtain missing data, data corrections, reviewing adverse events and protocol deviations.Review data and source documentation from investigational sites for accuracy and completenessFacilitate resolution of data queries and action items at clinical sitesPromptly reportsthe findings of monitoring visits according to Abbott processes.Maintainaccurate,detailedand complete records of monitoring visits.3. Provide training and procedure coverage:Apply clinical and technicalexpertiseto train site and Abbott staff for clinical trials and applicable commercial launches.As needed, provide clinical and technicalexpertisefor clinical trial procedure supportAttend study procedures and follow-ups (or ensure trained personnelattend).4. Collaborate with commercial partners:Whenappropriate, collaborate in the education of local sales groups on new product launches.Whenappropriate, contribute to the education of customers on new and existing Abbott products.Meet with key customers where Abbott GCO presence can elevate the customer experience.Act as anadditionalresource for technical questions and troubleshooting.5.Identifyand adapt to shifting priorities and competing demands.6. Remain current on developments in the field of expertise including clinical and Abbott product knowledge, competitive positioning and published scientific and economic evidence.Maintainat least one area of expertise and function as a local clinical and technical resource.7.Possessindependent problem-solving skills and ability to make decisions.8. Exhibit excellent oral and written communication skills.Require Qualifications:BachelorsDegree ( 16 years) Related field OR an equivalent combination of education and work experienceWorking technical knowledge and application of concepts,practicesand procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.Exercisesjudgment within defined procedures and practices to determineappropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on thesystemsenvironment.Minimum 2 years Related work experience with a good understanding of specified functional areaPreferred Qualifications:Bachelor's DegreeOrMaster'sDegreein engineering, science, health science, nursing, ora relatedfield, OR equivalent or related experience in cardiology or clinical research.2+years of progressively more responsible relevant clinical trial experience inthecardiovascular field.Competency incatheterizaionlab and operating roomprotocoland procedures.Ability to travel approximately 75%, including internationally.The base pay for this position is $60,000.00 $120,000.00. In specific locations, the pay range may vary from the range posted.