Sr. Clinical Research Associate (Remote)

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 109,000 colleagues serve people in more than 160 countries.About AbbottThe key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott''s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.Our pioneering technology spans the world of healthcare operations "” with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.Our location in San Diego, CA currently has an opportunity for a Sr Clinical Research Associate. WHAT YOU''LL DOConduct monitoring visits and activities in accordance with FDA Code of Federal Regulations, GCP guidelines, departmental SOPs, Work Instructions and the Clinical Monitoring PlanServe as primary site contact; establish and maintain regular communication with clinical sitesConduct Site-Qualification, Initiation, Interim and Closeout visits to include document review for accurate data recording, source data verification to protocol adherence and governing regulationsAssist with distribution, collection and tracking of regulatory documents for site compliance and audit readinessPrepare and maintain monitoring visit reports and site communication documentationIdentify and resolve routine site issues, protocol deviations, queries, study discrepancies and collects missing or incomplete informationFacilitate subject recruitment and retention programsIdentify and resolve site issuesProficient use of, and capability to train others, on EDC systemsProvide leadership/ training/mentoring of CRAs and CTAsProvide input and help facilitate the development of Site Monitoring Plan, informed consent forms, source document templates, Case Report Forms and other study related documentsCommunicate to CTM any observed study trendsDevelop clinical trial documents as requested by CTMQuality control review of clinical study reports, tables, listings and figures as requestedWork with minimal supervisionWork on multiple projects simultaneouslyAdditional project and tasks as determined by department and organizational needsTravel may be approximately 30íUCATION AND EXPERIENCE YOU''LL BRINGRequiredMinimum BA or BS in related field and 5 years of related experiencePreferredOn-site monitoring experience of IVD clinical studies is preferredAdvanced knowledge of clinical trial practices and regulationsAdvanced knowledge of clinical monitoring and trial designWorking knowledge of clinical trial databasesAdvanced technical writingProficient computer skills including Microsoft Office SuiteCompetenciesLeadershipCollaborationCommunicationInterpersonal SkillsInfluencing SkillsRelationship BuildingTeamworkTroubleshooting SkillsTechnical Writing SkillsWHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: 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 on Facebook at and on Twitter @AbbottNews and @AbbottGlobal. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Created: 2021-11-29