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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Santa Anna Trail,Augusta GA-Street Address
Email: EMAIL AVAILABLE Cell: PHONE NUMBER AVAILABLEAccomplished and result-oriented business professional with over 12 years experience in various fields of Health Care Practice Management with specialization in Opthalmology,Retina and Diabetes. Experienced in managing all aspects of clinical research including Regulatory, contracts/budgets, and financial administration.EDUCATIONOct 1994Oct 1996 Newport University,UTMaster of Business Administration- MarketingJuly 1991Apr 1993 University of MadrasMaster of Science in BiochemistryJun 1988May 1991 Bharathidasan UniversityBachelor of Science in ChemistryCLINICAL RESEARCH WORK HISTORY01/2021 Present Clinical Research/ Financial ManagerSoutheast Retina Center PC, Augusta GA07/2014 12/2021 Natural Sciences Practice & Clinical AdministratorSoutheast Retina Center PC, Augusta GA08/2009 07/2014 Biochemist/Clinical Research ManagerCenter for Podiatry Care /Aiyan Diabetes Center, Augusta GA07/1996 08/2000 Biochemist/Lab AdministratorSharon Clinical Laboratory, Trichy, IndiaCLINICAL RESEARCH OPERATIONAL SKILLSNegotiated over 100 CTA/Budgets and amendments with various CRO companies and sponsors like Genentech, Regeneron, Kodiak Sciences, Various leading Pharmaceuticals etc. including DRCR network and increased significant revenue for the site.In charge of development, review, and proper maintenance of study documents and tools (including study logs, case report forms, regulatory binders, and site IRB documents) to ensure protection of confidentiality of subjects in clinical trials.In charge of study feasibility calls, providing feasibility questionnaire data and PSV and SIV calls with Sponsors /CROs for new trials.Served as IRB site liaison and assisted in all IRB reporting and continuous review reporting for all site protocols with the regulatory coordinator.Adept in Reliance agreement creation and execution for new SUB-I with Academic Institutions who participate in Site protocols.Managed progress of clinical studies and assuring compliance with SOP, GCP guidelines, and federal regulations governing conduct of clinical studies.Coordinated smooth monitoring of all trials by identifying and managing qualified staff, establishing procedure to ensure that data is entered into the database in a timely fashion.Provided oversight over cross-functional study activities, identifying, and resolving issues, and communicating study timelines and deliverables.Developed recruitment strategies to increase patient randomization in the trial by supporting data mining activities in the EMR and spreadsheet with internal referrals sent by PILed all internal meetings and preparing minutes, budget reports, and activity reports for investigators as needed.Served as Sites Liaison and advocate with sponsors and PI in regulatory, quality control, and quality assurance matters.Coordinated external meetings, conferences, and events as needed by sponsors to increase subject recruitmentParticipated in study-specific invoice processing, creating and tracking purchase orders, delivery of shipments, and site and vendor payments.Served as site representative for IBC committee in ensuring safe use of biologic material in RGX gene therapy studiesIn charge of SOP development for all Clinical research process to ensure GCP guidelines are followedProvided other administrative support as needed, such as line management of clinical research staff including recruitment, protocol initial training, ongoing training, and directing other daily activities.Managed turnover and retention of clinical study staff to meet company objectives.Ensured that risk management policies are being followed.Identified, responded to potential and current risk management issues by coordinating with ASC Administrator.Provided oversight on general practice functions and revenue of practice by liaising with the accounting department and CPA, and the heads of the billing and human resources departments.Ensured that clinical strategies are translated into operational execution.Maintained drug inventory using Cubixx software and tracking purchase orders and invoices for the in-house compounding pharmacy.Ensured that the compounding pharmacy follows USP 797 in compounding sterile preparation.Coordinated with the pharmacist in educating clinic personnel about transmission, risk prevention, and appropriate precautions and assessments in dispensing drugs.Ensured staff compliance with drug dispensing SOP, including appropriate barcode scanning, creating unique labelling, and timely discarding expired medication.Provided oversight on refrigerator temperature logs and freezer temperature logs to ensure drug integrity and compliance and report temperature excursionsProvided oversight on all calibration logs for lab equipment and helped liaise with service technicians when troubleshooting.Developed Corrective action plan when deviation was reportedEducated staff on minimizing drug attrition occurring because of spoilage, drug expiration, and dropped vials, and maintaining timely reporting and discarding of expired drugs as per the drug SOP.Ensured adherence to all safety measures, including use of protective equipment, avoiding common problems and that all standards, including specimen integrity and proper labels with unique identifiers, are maintained in all shipments for all protocols.Ensured effective leadership in FDA audit process and ensured all updates were provided to auditors, IRBs sponsors and compliance processes and CAPAs were in place.Ensured sits audit readiness processes are in place.Ensured financial management of over 35 clinical trials and accurate bookkeeping and reporting to the corporate Finance and accounting team.Spearheaded and opened a new Sister Research site in Florence Sc .Actively working on creating Research sites in Greenville SCNegotiated CTA and budget for Sister Research sites at Bradenton, Florida.Served as Mentor and provided guidance to research Coordinators at sister site.OTHER PROFESSIONAL EXPERIENCE10/2007 10/2008 Management ConsultantArrowhead Technologies LLC,Tampa FL10/2002 11/2006 Quality AnalystTenatronics Ltd. Newmarket ON, CanadaCLINICAL SYSTEMS PROFICIENCYNextech EMR, Nextgen EMR, Maximeyes EMR, Athenahealth EMR, Medisoft EMRVeeva Vault eTMFRealtime CTMSEDC: iMedidata RAVE, InForm, datatrak, Phase forward, RedcapIWRS/IVRSQuickBooks and Quicken software - accounting and payrollMicrosoft OfficeCERTIFICATIONThe NIH Office of Clinical Research Training for human subject protection.CITI Training Course for Biomedical ResearcherIATA training from Mayo clinic shipping Dangerous Goods CertificationHarvard Clinical Research Institute Inform TrainingSoftware testing Automated and Manual CertificationDiploma In E commerceYellow belt certification in Lean six SigmaPost Graduate Diploma in Computer educationCertified java professional Aptech Computer EducationSoftware testing( manual, Automated,)SDLC,PM,CM,RM |
