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Clinical Research Associate I – Remote (USA only) in Abbott Park, IL in Abbott
Job title Clinical Research Associate I - Remote (USA only)Company AbbottJob 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 115,000 colleagues serve people in more than 160 countries.CLINICAL RESEARCH ASSOCIATE I – REMOTE (USA ONLY)About AbbottAbbott 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 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. You’ll also have access to• Career development with an international company where you can grow the career you dream of.• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO• An excellent retirement savings plan with high employer contribution• Tuition reimbursement, thestudent debt program and 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.The OpportunityOur Diagnostics business currently has an opportunity for aCLINICAL RESEARCH ASSOCIATE I.This position is based REMOTE - USA ONLY.Travel 40 % (mostly within USA but on rare occasion, international).The primary function of this position is to manage sites through life of trial and close-out, including, the implementation, coordination and conduct of clinical research activities in compliance with applicable Corporate and Divisional Policies and Procedures under supervision of the Clinical Manager.What You’ll Work OnCore Job ResponsibilitiesUnder supervision of the Clinical Manager, responsible for the following• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol.• Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators and site staff.• Communication with site staff including coordinators, clinical investigators, and their site staff;• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.• Source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.• Verification that the investigator is enrolling only eligible subjects/samples.• Ensures timely collection and review of study and regulatory documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.• Responsible for investigational product accountability and inventory.• Verification and review of adverse events to confirm accurate data reporting in accordance with the protocol.• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and• Timely completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.• Builds and maintains relationships with sites• Basic knowledge in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).Note This job description is not to be considered an exhaustive statement of duties, responsibilities or requirements and does not limit the assignment of additional duties for this role.Supervisory / Management ResponsibilitiesExempts/ Non-Exempts/ Contingent 0Direct Reports 0Indirect Reports 0Position AccountabilityReporting and Peer RelationshipsThis entry level position reports to the Clinical Manager.This position will interface with Clinical Project Teams, Research and Operational Managers who determine study objectives and resource needs.Position ScopeBegins establishing and cultivating a network of internal resources to facilitate completion of tasks. Will perform this job in a quality system environment. Completes daily work to meet established schedule with guidance from supervisor on prioritization of task. Minimal independent decision making; exercises authority within pre-established limits and approval. Individual influence is typically exerted at t
