| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
EMAIL AVAILABLEPHONE NUMBER AVAILABLEHIGHLIGHTS1992 present: Clinical Research which includes Regulatory experienceClinical Monitoring experiencePhase I, II, III, IV experienceTMF SpecialistCTA SpecialistTHERAPEUTIC EXPERIENCEOncologyNeurologyCardiologyHIVCNSPROFESSIONAL EXPERIENCE7/2023 Present Prevail InfoWorksProject CoordinatorMaintain list of study and site contacts as required. Keep contact info up to date.Manage system accessAssist with trial start up activities as requiredHelp with study plans/documentsCoordinate functional areasLiaison with vendors for study deliverablesAssist in development, finalization, and approval of trial specific documentsComplete trial level templatesAttend meetings, take minutes, track attendance, provide metrics as requires, update and maintain action itemsSupport HA/EC submission activities, prepare submission documents as neededAssist Safety group with site contact info as needed/verify their recipients list SUA/SUSARs, file any SUA reportsDistribute missing data reporting, assist in close out activitiesOther responsibilities assigned by Director, Clinical Operations3/2018 4/2023 Catalyst Clinical Research, Raleigh, NCCTA/eTMF Specialist (long term contract)Assist with data entry, proofing and distribution of project tracking reports that can include but is not limited to enrollment, monitoring visits, submission of trip reports and other study specific metrics.Responsible for updating the Trial Master File (TMF) in accordance with Eisai file structure.Perform quarterly audits on studies in the eTMF, maintain the filing for all studies, ensure all document are filed correctly in the eTMFResponsible for routine maintenance of the TMF, including general filing and periodic auditing of files as directed by the Project Manager or Eisai Director.Assist with the distribution and tracking of study supplies, including reference manuals and regulatory packets as well as study specific supplies as needed.Responsible for the collection and tracking of regulatory documents using Eisai systemsWork with study team members to ensure that all study documents and files are accurate and current.Coordinate and participate in team meeting; generate and distribute team meeting minutes.Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow as assigned.May serve as a central contact for the clinical team for designated project communications, correspondence and associated documentation.Perform other duties as assigned which may entail supporting other Eisai studies/protocols9/2017 2/2018 EmergeOrtho, Durham, NCPatient Support SpecialistGreet and assist all patients and other visitors who arrive to EmergeOrtho.Checks in patients for appointments, reviews and verifies demographics, confirming insurance eligibility, collecting all due balances, deposits and co-payments.Provide patients with prescriptions, medical records and other needs as requested.11/2016 4/2017 CMED Research, Durham, NCRegulatory Specialist (Contract position)Perform quality review of regulatory documents required for country approval In accordance with all applicable regulations, guidelines and Cmed proceduresPerform quality review and approval of regulatory documents required for site Initiation/drug release In accordance with all applicable regulations, guidelines andCmed procedures. These documents include, but are not limited to; required regulatory document packages, Informed consents, advertisements and patient related materialsEnsure that Regulatory Authority, Central and local EC submission timelines are metResponsible for timely follow-up for Inquiries or objections made by RA/EC In collaboration with study teamPerform timely and accurate data entry of regulatory documents and maintenance ofcountry/investigator Information In the appropriate clinical trial management systemPerform regulatory document maintenance, amendments, periodic update and safety letters (safety reporting responsibilities In collaboration with the Drug Safety group)Meet or exceed metrics for review and submission of completed RA/EC packets as defined by theRegulatory Manager/Lead/Designee at study startMeet or exceed metrics for error rate of completed RA/EC packets as defined by the RegulatoryCompetent In communication skills for timely follow-up, Issue resolution and report updates; as outlined In the communication and escalation plan with timely documentationRegulatory expertise and guidanceAttend study team meetings as requiredAssemble and distribute study materials to clinical and project teams, Including materials to study sites and Investigator Meetings (e.g., Investigator binders) and vendors as appropriateResponsible for compliance with applicable corporate and divisional policies and proceduresBroad knowledge of various technical alternatives and their potential Impact on the businessCoordinate Instructions for Use (IFU) and Informed Consent Form (IOF) development activitiesParticipate In department systems development InitiativesPerform work without appreciable directionReview completed work from a relatively from a relatively long-term perspective, for desired resultsAssume additional responsibilities as directed by the Clinical and Regulatory Operations groupSupport the Clinical and Regulatory Operations group with Improvement activities by providing Ideas, Implementation activities and adapting SOPsMaintain confidentiality of management Information as appropriate03/2015 09/2016 MedSource, Raleigh, NCRegulatory Affairs SpecialistAssist with collecting, logging, filing, and/or tracking of study documents/trial master file in the project tracking system including site correspondence, vendor correspondence, IRB submissions and approvals, IND safety reports, case report forms (CRFs), regulatory and other study documents according to client/company Standard Operating Procedures (SOPs), ICH, and federal regulationsAssist with coordinating regulatory workflow, provide support to the regulatory team, and track regulatory project timelinesReceive and disseminate study-related regulatory documents and correspondence from assigned sites; screen documents for completeness and compliance with protocol and appropriate regulations; investigate incomplete, inaccurate, or missing documents to ensure accuracy and completeness of dataAssist in the production and distribution of various study-related, investigator, regulatory tools, and documentation (correspondence, operations, guidelines, training manuals, study forms, site regulatory binders, and worksheets)Create and maintain tracking tools in support of project needs and in-house functionsPrepare reports from tracking tools to include weekly reports and other reports as requestedCommunicate with sites to provide information, request updates, track documentation, and help to ensure the overall progress of clinical trials and adherence to established guidelinesEnsure that study materials and drug kits are shipped and re-supplied as requested; respond to routine questions related to study protocol and refer more complex questions to management as appropriateCommunicate regularly with study monitors as needed to resolve discrepancies and provide information before and after monitoring visits to participating sitesCommunicate and coordinate with other study personnel including data entry and randomization personnel, pharmacy, laboratories, study sponsors, and others as needed for study implementation and routine problem resolutionAttend routine weekly meetings and other meetings related to assigned clinical trials and corporate projects; stay abreast of information and any changes to study protocol and project timelinesWhen specified, scan study-related documents and ensure that the quality of the electronic document is adequate, correct naming conventions are utilized, and verify the paper file matches the electronic fileProvide assistance with meetings (e.g., investigator, kick-off, team, etc.) and preparation of meeting agendas, minutes, and action items as neededPrepare, proofread, and edit correspondence and other written materials (presentation, reports, etc.) as neededProvide filing, faxing, photocopying, and mailing support for designated projectteam(s) as required12/2013 03/2015 GSK, Research Triangle Park, NCClinical Study Associate / Regulatory SpecialistSend CDAs to 600 potential sites in order to select a total of 350Send feasibility to sites as neededAttending site selection meetings weekly and giving updatesBeginning discussions of the upcoming Investigators MeetingsDaily tracking of sites statusSending site selection letters weekly03/2013 09/2013 GSK, Research Triangle Park, NCStudy ManagerSet up and maintain ISS studies in the Lotus Notes DatabasePerform bi-monthly file reviewsMaintain studies in eTrackContact study sites bi-monthly for study updatesProvide Monthly Budget Updates to the Finance TeamsTrack and maintain the Publications databaseTrack milestone payments to sitesPerform quarterly milestone reconciliationFill out Proposal Summaries for new proposed studies, request contracts07/2009 02/2013 Quintiles, Morrisville, NCIn-House Clinical Research AssociateCollect, track and review study site critical documents used to monitor interest for enrollment of investigative sitesEnsure compliance with protocol guidelines and requirements of regulatory agencies, including the provisions of the Anti-Kickback Statute (USA) and the False Claims Act (USA)Thoroughly document and track all communication (email, voice, fax, call reports) with all study site personnel and any client interaction in accordance with study plansMay assist in the development of site specific recruitment, retention and follow up plans / processes in line with the project strategy provided by Project Coordination Centre (PCC) LeadEnsure the site is recording data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources in accordance with study plansFollow established guidelines in the collection and tracking of clinical data and resolution of data queries in accordance with study plans and client preferencesEvaluate and assure quality of data collected; ensure that all data and study documents are handled consistently with the demands of regulatory agencies with respect to data protectionIdentify problems and/or inconsistencies; monitor site and subject progress, including documentation and reporting of adverse events; recommend corrective action as appropriate; escalate to PCC Lead or line manager as appropriateRespond to questions on study procedures/protocol via the study hotlineLiaise and work in conjunction with CRAs monitoring on-site as neededPerform on-site co-monitoring and remote monitoring activities as neededProvide guidance to PCC Clinical Assistant staff as needed04/2008 11/2008 Quintiles, Morrisville, NCAssociate Site Start-up SpecialistReview and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.Resolve site issues and report site status to SSU Team Lead.Work with regulatory team members or sponsor to secure authorization of regulatory documents.Work with legal team members or sponsor to secure authorization of contracts.Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.Inform team members of completion of regulatory and contractual documents for individual sites.Work with team members in preparation of regulatory submissions per work instructions.May coordinate translation of critical documents.May participate in feasibility and/or site identification activities.01/2009 05/2009 Novella, Research Triangle Park, NCSenior Regulatory Affairs SpecialistSupport sponsor Study Management by providing study start up, maintenance and close-out activities for assigned studiesGather, enter, interpret and apply information into various sponsor systems to support studiesCheck own work and correct errorsCreate and utilize customized reports develop basic information management solutions, participate in clinical team activities as assigned and contribute to deliverablesParticipate in the development and implementation of key organizational process improvement initiativesWork within standardized best practicesEnsure study related logistics are completedWhen escalating complex requests, recognize underlying issues and communicate as appropriateParticipate in interviewing process of new hires as requestedTrain and mentor entry-level or new staff as directedCoordinate workflow, staff and tasks to accomplish study or project deliverables as requestedSet up and maintain method of tracking for study budget spendReview and reconcile invoices/spend, and facilitate/coordinate investigator paymentsCoordinate the preparation and the routing of clinical study agreements and ensure that fully executed agreements are in place prior to drug shipment and paymentOrder, assemble, distribute, manage and track study conduct tools, and non-drug clinical suppliesObtain, set up, and maintain sponsor study records according to FDA/ICH Guidelines and internal SOPTravel to sites and/or CROs to conduct file review, reconciliation and other closeout activities as requestedCollect, review and submit required documentation to TCS throughout the studyLiaise with meeting planning vendor in the logistical planning of study meetings (Investigator, CRO, Coordinator)Assemble materials and travel to or attend meetings as neededContribute to content of Investigator Meetings and present at meetings as appropriateReconcile FIDS, CARDS and sponsor study records to provide documents to Records Management04/1992 03/2008 GlaxoSmithKline, Research Triangle Park, NCClinical Study AssociateRoutine administrative duties that included but not limited to study start up activities, maintenance, as well as close-out activitiesAdhere to the GCP and ICH guidelines, FDA regulations and GSK SOPsParticipated in site recruitment activities that includes searching intranet for possible investigators to participate in the trial, present to team members at site selection meetingsMaintained investigator list on several required databasesPrepared and pre-populated regulatory documents for site mailings, received documents for review, submitted regulatory documents to regulatory for review as well as IRBAssisted with travel arrangements and prepared expense report templates for investigator meetingAttended investigator meetings, prepared power point slides, present regulatory document collection process as well as assist with travel reservations, dinner reservations and computer training set upBudgets: prepared contracts, reviewed contracts and tracked accrualsMaintained database to track vendor payments, investigator payments and invoice processes. Communicated with external vendors regarding invoicesTracked site information, regulatory documents and SAEs in several databases as well as on Excel spreadsheetsAttended study conduct meetings; prepared meeting minutes, stored minutes on shared areaRan weekly reports of study progress that included regulatory status, patient data information, IRB submissions, and budget informationActivated drug shipments, tracked drug shipments, and collected drug accountability logs for files. Tracked patient visits to ensure timelines were met per protocolCompared databases for correct data transfers of patient dataWorked close with data management on database comparisons, ran weekly reports and reported data at study conduct meetings10/1988 04/1992 ClinTrials, Research Triangle Park, NCAdministrative AssistantSecretarial support for statisticians, research support and department headsInvolved in typing final study reports, setting up tables for reports, logging in case report forms and assisted in quality assurance auditsPerform general secretarial duties for the monitoring department and assigned to different projects to type memos to investigators, take minutes at project specific meetings, perform mail merges, back-up secretarial support on the switchboardGCP TRAININGNIH: Protecting Human Research Participants, Jan2024 |
