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Title Clinical Research Accounts Payable/Receivable Billing Specialist
Target Location US-FL-Jacksonville
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Candidate's Name
A highly experienced Certified Clinical Research Professional currently an Associate Principal, Site Payment Specialist with experience as a Budget/Contract specialist, Financial Analyst, Clinical Research Manager, Study Start Up, Accounts Payable/Receivable and Regulatory Affairs with considerable global experience within the CRO/Pharmaceutical/Medical Devices communities in all phases and indications. EDUCATIONYear: 2010 Master of Business Administration and Finance, Capella University, Minneapolis, MN Year: 2005 Bachelor of Science (Professional Studies), University of North Florida, Jacksonville, FL EXPERIENCEDate: From April 2024 to presentCompany Name: ESS servicesJob title: Substitute Teacher (all grades), Paraprofessional ESE/ESLManaging classrooms and teacher lesson plans in their absence.Taking attendance, maintaining classroom environment, and monitoring the class for assistance.Always supervise students in and out of the classroom.Support students with emotional, physical and behavior concerns in developing the appropriate social skills as identified in the behavior intervention plan.Date: From Jul 2023 to Jan 2024Company Name: Premier ResearchJob title: Associate Principal, Site Payments Specialist Schedules and leads kick-off meetings (KOM) globally for all projects assigned. Develops and manages study timelines including the initial startup payments timelines. Drafts, manages, and oversees study level requirement documents outlining set up for configurations of all sites and ensures site configuration in eClinicalGPS is consistent with EDC configurations. Monitors site contract configuration and issue resolution by proactively collaborating with other financial roles to retrieve missing documents or information prior to reaching out to the site. Reviews and tracks the remaining balance of the purchase order for the global project. Perform accounts payable and receivables review with all projects up to 16 billion.Date: From Apr 2022 to Jun 2023Company Name: Premier ResearchJob title: Associate Manager, Data Operations Responsible for the recruitment and line management of data operations staff including staff resourcing, communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; developing, coordinating, and enforcing policies, procedures, and productivity standards. Manages data operations projects by ensuring quality and customer service; analyzing and resolving quality and customer service problems; identifying trends; recommending system improvements. Administers financial compensation for direct reports and proposes adjustments (e.g., promotions, market adjustments, etc.) to management with account payable and receivable review.Date: From April 2023 to presentCompany Name: Bella Labae Enterprise LLCJob title: Owner Photography, 360 photo booth rental, party, and event planning in the Florida area. Create invoices, bookkeeping, customer service, accounts payable and receivable for the business. Ordering supplies, maintenance of equipment and marketing for business.Date: From May 2021 to Mar 2022Company Name: PRA Health Sciences/ICON Pharmaceutical Job title: Study Start Up Lead 2/Site Activation Manager Oversaw the Local Regulatory Affairs Lead (LRAL), Contracts Associate (CA) and In- House Clinical Research Associate (IHCRA) ensuring essential regulatory documents for allocated regions globally were developed, collected, reviewed, and tracked according to the processes and timelines agreed upon on the project. Implemented the project start-up methodology, to include project parameters, subject recruitment months and high-level study start-up activities/statuses) and documented the information within the Project Start-up Plan (PSP), CTMS and the Project Start-up Summary. Created, maintained, and facilitated Sponsor Approval of project documents related to study start-up, including the Essential Document Templates, Essential Document Review Requirements, Country, and Site Standard investigational Product Release forms for global projects. Reviewing all FDA regulatory documents sent for each site accuracy, uploaded and filed in TMF/Activate for all protocol versions. Date: From Dec 2020 to May 2021Company Name: PPD PharmaceuticalJob title: Senior Country Approval Specialist Coordinated with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines for study activations. Ensured alignment of submission process for sites and study were aligned to the critical path for site activation. Prepared, reviewed, and coordinated local regulatory submissions (MoH, EC/IRB additional special national local applications, if applicable, e.g., gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. Date: From Dec 2019 to Dec 2020Company Name: Centene CorporationJob title: Program Coordinator Completed all 701b state assessments for Broward County, Florida Medicaid contract participants to continue participants coverage. Confirmed eligibility for participants for services in the home for long-term care via customer service with all Florida counties and members as needed. Processed ID cards, letters to case workers and file documents into system for scanning. Date: From May 2017 to Oct 2019Company Name: Mayo ClinicJob title: Research Clinical Studies Supervisor Management experience with 20 employees for 130 new clinical trials assigned monthly through the project life cycle collaborations with multiple ancillary services at the hospital and clinical practice with 500 plus ongoing trials in various stages. Provided education, mentoring and trained staff for regulatory requirements support of 172 doctors, protocol amendments and contract modifications for clinical research trials, start up to closeout costs on drug, device, hematology, oncology with non-cancer therapeutic experience. Trained, developed, and mentored staff for quality programs with created processes, workflows, tools, and dedicated teamwork. Date: From May 2012 to May 2017Company Name: Mayo ClinicJob title: Research Revenue Analyst II/ Finance Analyst II/Code and Coverage Analysis Audited more than 350 assigned clinical trials all indications with analytical and technical skills for federal, foundations and industry sponsored for accuracy within the budgets reflecting the full test schedule /schedule of events in the protocol with distinction of standard of care and research items costs. Executed quality reviews for informed consent discrepancies, contract, payment terms omissions, and final budget exhibits for consistency and finance/accounting reconciliation prior to activations for research finance. Verifying RVUs reviewed and accounted to correct unit PAUs and activities. Develop budget and cost proposals. Preparing cost proposal narratives including benchmarking for procedures, overhead and invoiceable on proposal. Counteroffer on budgets as needed and escalate to legal/chair if needed. Review local coverage decisions (LCDs) and national coverage decisions (NCDS) on all qualifying clinical trials. Process, review, and implement CDAs, NDAs, MSA and BMLs. Prepare weekly & monthly cost reports via Business objects for PAUs, and activity numbers for multiple projects and reconciliations. Date: From Feb 2007 to May 2012Company Name: Mayo ClinicJob title: Protocol Development Coordinator/Masters Level Study Coordinator Clinical project management, protocol development, accounting and regulatory management pre and post approval from pre-site visit to close out visit for 20 plus studies at one time. Lead core project team for each indication in hematology, oncology, neurology and facilitate their ability to lead extended/complete project team. Ensure clinical trials are conducted, reported in accordance with the protocol, standard operating procedures, ICH-GCP (Good Clinical Practice) guidelines and all applicable local regulatory authority requirements.  Maintained a working knowledge of ICH/GCP (Good Clinical Practice) guidelines, other applicable guidance and regulations regarding investigational drug.  Developed and assisted writing clinical trials(outlining the purpose and methodology of a trial) for hematology and oncology trials.  Entered health data into clinical databases for review, accountability and auditing on trials. Completed and/or reviewed queries for the federal funded ECOG and GOG studies opened in Florida. Date: From Feb 2005 to Feb 2007Company Name: Jacksonville Heart Center/Baptist Heart Specialist Job title: Regulatory Affairs Specialist/In house Clinical Research Associate Organized, dated, submitted, tracked and filed regulatory documents for 27 research clinical trials across 6 satellite sites. In house clinical monitoring experience (EDC system Bioclinica and Enforme) in preparation for regional monitor visits. Conducted pre-site qualification visits, site initiation visits, interim monitoring visits and close out visits, where applicable, both remote, via WebEx and/or site. Verified data entered on to CRFs was consistent with patient clinical notes, known as source data/document verification (SDV). Date: From Feb 2003 to February 2005Company Name: Jacksonville Heart Center/Baptist Heart Specialist Job title: Medical Billing Specialist Lead/Accounts Receivable/Payable Entered all insurance payments and specialty invoice checks for 16 doctors, up to 16 million dollars annually for 4 offices. Act as team lead over 10 people regarding accounts and collections. Examined and submitted denials for processing to appropriate insurance. Delegated current denials to appropriate reps for follow up. Reconciled daily insurance receipts for depositing. Review accounts for proper CPT coding and ICD9 coding. Answer patients complaints and concerns regarding accounts by correspondence or phone. Thoroughly process insurance/patient refund requests for issuance. Posting electronic remittance of Medicare and processing exception report. Report problematic trends with payments, diagnosis, procedures, etc. to management.

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