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C H U R C H I L L I N N E HNashville, TNPhone: PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLEPrincipal/Sr.Clinical Research AssociateDedicated and highly skilled Principal/Senior Clinical Research Associate with over 8 years of extensive experience in the pharmaceutical, CRO, and healthcare industry. Demonstrated expertise in monitoring and managing studies across diverse therapeutic areas, including Ophthalmology, Medical Device-IVD, Infectious Disease, Central Nervous System, Womens Health, and Oncology. Seeking a challenging role as a Senior Clinical Research Associate/Principal CRA where I can leverage my wealth of experience and contribute to the success of clinical studies. Currently, I am actively exploring new opportunities in which I can apply my skills and knowledge to drive study excellence and advance the field of clinical research.EducationMaster of Science  MSc. Physiology May.2017, University of BeninBachelor of Science- BSc. Physiology Dec.2008, University of Benin ExperienceNatera Sep 2019  PresentSr. Clinical Research AssociateCommunicate effectively with investigators, site staff, and sponsor representatives.Track and manage site payments in accordance with contractual agreements.Collaborate with cross-functional teams, including data management, biostatistics, and medical monitoringAssist project team with study start-up activities including, site budget review, site contract review, and site selectionUpdate study dash boards with site updates, enrollment status and potential site recruitment challenges.Conduct weekly phone/email follow-up with investigators regarding AEs, SAEs and PDs related to the study drug.Assist CTM with study document creation including, monitoring plans, CRFs, and lab/pharmacy manualsParticipate in weekly CRA team calls and Data Management calls to provide study teams with necessary site updates and data trends.Review trip reports for ROW CRAs and junior level CRAsPerform routine e-TMF check to ensure TMF complianceManaged and monitor sites in accordance to study protocols, SOPs, ICH-GCP and FDA guidelines.Verify qualification for all potential investigative sites prior to any study conduct.Conduct site visits of all kinds, PSSVs, SIVs, IMVs, COVs and Co-Monitoring.Monitor progress of clinical trials ensuring conduct, data records and reports are in accordance to Good Clinical Practice (GCP) protocol, relevant regulatory requirements, and Standard Operating Procedures (SOPs).Review Case Report Forms and source documents to ensure subject safety, investigator compliance, site adherence to protocol and overall clinical objectives.Quickly resolve queries and random study site issues to maintain study progress and also prevent protocol deviations and regulatory penalties.Support Investigator sites with trial execution through proper training and subject recruitmentTrain and mentor newly hire Clinical Research AssociateVerification that the investigator is enrolling only eligible subjects per the inclusion and exclusion criteria.Conducting investigational product/drug accountability and inventory through IWRS and accountability logsCommunication with the medical site staff including coordinators, clinical research physicians and their site staff.Participate in routine study data cleaning, including Database Lock and Data Review meetingsWork closely with data management team to review consistent deviations across multiple sitesServe as team lead on heart/lung studiesIntegrium Clinical Research Jul 2016  Aug 2019Clinical Research Associate IIResponsible for site monitoring, site management, site administration and registry management for clinical studies according to GCP-ICH and FDA guidelines as well as company standard operating procedures.Ensure the accuracy of all data generated and collected from clinical sites.Create trackers for study data including protocol deviationsWork closely with the project management team to track data trends and ongoing protocol deviationsAssist CTM with all study start-up activities including drafting Feasibility Questionnaires, study manuals, risk management plan etc.Monitored risk based studies and provided study team with potential risks identifiedEnsure the safety of all subjects by thoroughly reviewing all study related protocols and ICF, as well as verifying source documentation 100%Maintain study/site trackers and ensure study dashboard is updatedVerify qualification for all potential investigative sites prior to any study conduct.Conduct site visits of all kinds, PSSVs, SIVs, IMVs, COVs and Co-MonitoringMeet with data management team on a bi-weekly basis to discuss pending SDV metrics and open/closed queries.Monitored progress of clinical trials ensuring conduct, data records and reports are in accordance to Good Clinical Practice (GCP) protocol, relevant regulatory requirements, and Standard Operating Procedures (SOPs).Review Case Report Forms and source documents to ensure subject safety, investigator compliance, site adherence to protocol and overall clinical objectives.Quickly resolve queries and random study site issues to maintain study progress and also prevent protocol deviations and regulatory penalties.Support Investigator sites with trial execution through proper training and subject recruitmentTrain and mentor newly hire Clinical Research AssociateVerification that the investigator is enrolling only eligible subjects per the inclusion and exclusion criteria.Conducting investigational product/drug accountability and inventory through IWRS and accountability logsCommunication with the medical site staff including coordinators, clinical research physicians and their site staff.Ensure the timely reporting of all SAEs, and protocol deviations. Integrium Clinical Research Aug 2014  Jul 2016Entry level Clinical Research Associate ICompleted 1 year of entry level CRA training via CRA training course and observational/co- monitoring visits (PSSVs, SIVs, IMVs and COVs).Participated in protocol review and protocol training callsParticipated on study start-up activities including potential sites identificationConducted monitoring visits of each kind including PSSVs, SIVs, IMVs, and COVsAssisted study team with IP tracking and distributionAssisted study team with study data reviewPerformed SDV at 100%Participated on clinical monitoring callsDrafted/reviewed ICFs and submitted ICFs to the IRBPrepared study start-up documents for IRB submissionEnsured the accuracy of all data generated and collected from clinical sites.Participated on TMF reconciliation activitiesPerformed UATs on all project assigned EDC systemsManaged and monitored sites in accordance to study protocols, SOPs, ICH-GCP and FDA guidelines.Ensured the safety of all subjects by thoroughly reviewing all study related protocols and ICF, as well as verifying source documentationVerified qualification for all potential investigative sites prior to any study conduct.Monitored progress of clinical trials ensuring conduct, data records and reports are in accordance to Good Clinical Practice (GCP) protocol, relevant regulatory requirements, and Standard Operating Procedures (SOPs).Quickly resolved all queries and study site issues to maintainEnsured all deviations and SAEs are reported in a timely manner.Support Investigator sites with trial execution through proper training and subject recruitmentVerification that the investigator is enrolling only eligible subjects per the inclusion and exclusion criteria.Conducted investigational product/drug accountability and inventory through IWRS and accountability logsCommunicated with the medical site staff including coordinators, clinical research physicians and their site staff.University of Tennessee Medical Center Sep 2011 Jun 2014 Assistant Lab ManagerPlan, organize and oversee daily operations of the laboratoryProcure, maintain, and calibrate laboratory equipment and instruments.Effectively train laboratory staff on the appropriate usage of lab machinesImplement and maintain quality control measuresManage and maintain laboratory inventory of supplies,Organized and sorted samples and specimen collected from patients for lab processing.Arranged delivered reports from collected data.Assisted lab staff with labeling and packaging of all shipped lab samplesUpdated lab normal ranges in various systemsResponsible for coordinating sample pickup and shipmentExamined body fluids and cells collected from study population.Used lab results to report accurate results and help organize results. Additional ExperienceSystems Experience:EDC: Abond, Veeva, iMedNet, Oracle, CastorCTMS: Medidata Rave, Veeva Vault, Clinplus, Advarra TMF: Veeva Vault