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Click here or scroll down to respond to this candidateCandidate's Name
PHONE NUMBER AVAILABLERaleigh, North Carolina, United StatesEMAIL AVAILABLELINKEDIN LINK AVAILABLEExperienceTitle ClerkHertz Car SalesNovember 2023 - presentWorking in the car sales division as title clerk processing all titles for vehicles ready for sale and all cars sold.Do a weekly audit to verify that we have all titles assigned to our location. Help with customers buying vehicles - until a salesman becomes available. Make a daily listing of all cars available for sale for the sales people. Help with bi-weekly car inventories.Transport cars to and from storage lot and mechanic (when needed). Assist with office cleaning.Front Desk AttendantCozy Cat Veterinary HospitalMar 2023 - Oct 2023 (7 months)Check in and check out clients.Collect payments from clients.Pet and hold the friendly cats.Make and change appointments.Process prescriptions that come from outside pharmacies. Update client charts.Verify incoming package contents to invoice and stock shelves. Study Start Up Coordinator1PSI CRO AGJan 2022 - Sep 2022 (9 months)Informed Consent review, Ethics Committees/Institutional Review Board submissions and communications, protocol amendment management, submissions and follow-up to the appropriate governing authorities on a per country basis. Proactively forecasts submission / approval timelines and ensures they are adhered to. If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified. Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety information.Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements ICH / GCP guidelines l.Prepares checklist for IP release according to country regulations . Track the completion of site regulatory documents in the study CTMS and ensure ongoing updates are reviewed tracked and filed appropriately. Review and approve site specific Informed Consent Form Templates. Work with sites to ensure data collection and cleaning are complete and benchmarks / timelines for completion are maintained. Including resolving data queries and collection of source documents to support end point adjudication. Work closely with study sites to complete study start up by facilitating site regulatory approval and contract completion.2SSUAPremier ResearchJul 2019 - Dec 2021 (2 years 6 months)Start-Up Associate performs all country specific tasks associated with the start-up of a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements. Work with the Site Recruitment Specialist to provide study start-up metrics and site contact information.Informed Consent review, Ethics Committees/Institutional Review Board submissions and communications, protocol amendment management, submissions and follow-up to the appropriate governing authorities on a per country basis. Transition all study start-up complete sites to the Study Maintenance Associate within timeline and in general all needed preparations for site activation. SSUA serves as the primary point of contact for the Project Manager, Clinical Manager, Clinical and Regulatory Start-up Lead (or designee) during start-up on allocated projects. Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety information.Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.Prepares checklist for IP release according to country regulations. 3DriverEnterpriseApr 2019 - Jul 2019 (4 months)Drive rental vehicles from RDU Airport to and from local offices and around the airport. Clinical Trial CoordinatorDuke Clinical Research InstituteFeb 2004 - Mar 2019 (15 years 1 month)Use critical thinking skills to assess investigator and site qualification for a particular protocol l. Work closely with study sites to complete startup by facilitating local regulatory approval and negotiating study budgets to completion.Track the completion of site regulatory documents in the study CTMS and ensure ongoing updates are reviewed tracked and filed appropriately.Work with sites to ensure data collection and cleaning are complete and benchmarks/timelines for completion are maintained. Including resolving data queries and collection of source documents to support end point adjudication.Independently create new and customize existing templates to meet project needs. Assist Study Lead CRA and PL with cross functional project specific activities. Run weekly and biweekly reports for the sponsor.Update CTMS database for the site management team and the monitoring team. Adding new documents, milestones, etc. Updates to DEG as well. Developed a drug accountability log that was approved by the sponsor and used by all sites. Provided CTMS training for the regional AROsAssist the CRA Lead on all other site material development, production and shipping to all ARO sites, assuring the supplies are adequate and delivered to sites in a timely manner. Follow up with sites to resolve and close action items (Follow-up items) issued by the on-site monitors.Work with Project Office to keep the protocol updated in CTMS (i.e. safety letters, new documents). Developed spreadsheets to track enrollment, screening logs, site selection and clinical supplies shipping dates.Prepared and distributed weekly reports to the sponsor and DCRI CV Mega Trials leadership. The reports included enrollment, screening log exclusion factors, site start up figures and site demographics.4Cashier and Pharmacy TechnicianCVS PharmacyNov 2001 - May 2004 (2 years 7 months)Finance CEO's Assistant and A/P & A/R ClerkTravel Management PartnersMar 1999 - Apr 2003 (4 years 2 months)Pharmacy CashierKerr DrugsNov 1998 - Jan 2001 (2 years 3 months)Owner's Assistant and Finance ClerkTravel Experts, Inc.Apr 1996 - Feb 1999 (2 years 11 months)EducationU.S. Career InstituteMedical Assistant Certificate, Medical/Clinical Assistant 2016 - 2017Penn Foster GroupDiploma, Pharmacy Technician/Assistant2009 - 2010Comprehensive course designed to prepare one for state specific accreditation North Carolina State UniversityNatural Resources Recreation Major1983 - 1986Greenwich Central School Greenwich NYState of New York Regents Scholarship 1978 - 1983SkillsRegulatory Guidelines Life Sciences Office Administration Medical Research Administrative Assistance Drug Development Computer Literacy Quality Control ICH Trial Master File 5 |
