Clinical Research Financial Analyst
Resume:
Tiffany Goethe
Goethe, Tiffany, CV April ****
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SUMMARY
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 and Regulatory Affairs with considerable global experience within the CRO/Pharmaceutical/Medical Devices communities. Key experiences are within hematology, oncology, cardiovascular, neurology, general studies areas, and all phases. EDUCATION
Year: 2010
Master of Business Administration and Finance, Capella University, Minneapolis, MN Year: 2005
Bachelor of Science (Professional Studies), University of North Florida, Jacksonville, FL EXPERIENCE
Date: From Jul 2023 to Jan 2024
Company Name: Premier Research
Job 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.
• Schedules and facilitates the requirements document meeting to ensures payments are processed without issues or delays.
• Performs quality control on study configuration with finalized requirements document.
• 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.
• Ensures sites with executed contracts are configured in eClinicalGPS, user access is granted, and start-up payment is requested.
• Schedules and conducts regular check-in meetings with study team globally and CROs to review the study status and to address any issues/concerns.
• Reviews and tracks the remaining balance of the purchase order for the global project.
• Complete issuance for 18 ongoing projects for payments biweekly and some weekly confirming all released and correct amounts.
• Troubleshoots issues and ensures problems are seen to resolution.
• Liaises with the sponsor as needed to resolve issues that cannot be resolved within the organization.
• Trains and mentors Senior Site Payment Specialist, Site Payment Specialist, and Associate Site Payment Specialists.
Tiffany Goethe
Goethe, Tiffany, CV April 2024
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Date: From Apr 2022 to Jun 2023
Company Name: Premier Research
Job 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; analysing and resolving quality and customer service problems; identifying trends; recommending system improvements.
• Build and maintain long-term rapport and relationships with customers to ensure their expectations are continuously exceeded.
• Administers financial compensation for direct reports and proposes adjustments (e.g., promotions, market adjustments, etc.) to management.
• Represents the data operations team in audits and in corporate initiatives, as appropriate.
• Provides support, mentoring, and training to staff, as needed.
• Completes assigned Invoice Specialist project work and study related activities.
• Performs additional duties as assigned.
Date: From May 2021 to Mar 2022
Company 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.
• Entered summary of key role and responsibilities for current position using bullet points.
• Oversaw site identification and recruitment activities for allocated countries; including, liaising with other departments when additional sites were needed, and escalated delays, where applicable.
• Reviewing all regulatory documents sent for each site accuracy, uploaded and filed in TMF/Activate for all protocol versions.
• Attend and bid during bid defense meetings as needed. Tiffany Goethe
Goethe, Tiffany, CV April 2024
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Date: From Dec 2020 to May 2021
Company Name: PPD Pharmaceutical
Job 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.
• 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, additional special national local applications, if applicable, e.g., gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Acted as a key-contact at country level for all submission-related activities.
• Attend and bid in bid defense meetings as needed. Date: From Dec 2019 to Dec 2020
Company Name: Centene Corporation
Job 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.
• Processed ID cards, letters to case workers and file documents into system for scanning. Date: From May 2017 to Oct 2019
Company Name: Mayo Clinic
Job 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.
Tiffany Goethe
Goethe, Tiffany, CV April 2024
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Date: From May 2012 to May 2017
Company Name: Mayo Clinic
Job 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.
• Ensure the successful negotiations and on-going management of clinical trial agreements with investigative sites.
• SME on Florida campus for CRCs, OSPA and PIs for CPT codes, IRB application/documents and research procedure billing and compliance while providing education with research finance.
• 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.
• Generate reports for Vice Chair, administration, and managers on profit loss or gain on studies. Administer corrections or errors on cost allocated to incorrect activities on balance sheets.
• Budget and contract negotiations.
Date: From Feb 2007 to May 2012
Company Name: Mayo Clinic
Job 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.
• Lead cross-unit coordination both internal and external, inclusive of sub-contractors.
• Define and manage project resource needs and establish contingency plans for key resources.
• Ensure successful design, implementation, tracking and revision of project plans for assigned projects.
• Promote effective teamwork among project team members.
• Ensure appropriate communication on project-related matters with the PM Management team.
• Meet financial performance targets for the assigned clinical projects.
• Ensure project deliverables are met according to both worldwide and client expectations.
• Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects.
• Act as key client contact for assigned projects. Tiffany Goethe
Goethe, Tiffany, CV April 2024
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• Establish excellent working relationships with client project teams and vendors to ensure client satisfaction and operational excellence.
• Ensure that all staff allocated to assigned projects adheres to professional standards and SOPs established for clinical research.
• 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 2007
Company 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.
• Verifying pharmacy accountability in the practice.
• 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 2005
Company 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 patient’s 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.
• Functioned independently within the unit assisting other representatives and senior advisors with special projects with instant deadlines and questions. Maintained up to date knowledge on revenue recognition systems and practice billing systems. Tiffany Goethe
Goethe, Tiffany, CV April 2024
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THERAPEUTIC EXPERIENCE
Therapeutic Area & Phase
• Cardiovascular, US and Global
o Phases II, IIb/III, III, and IV – Hypertension
• Hematology, US and Global
o Phases I, Ia Ib, II, IIb/III, III, and IV – MM, Leukemia, Lymphoma, Sickle- Cell Anemia,
• Oncology, US and Global
o Phases I, Ia, Ib, II, IIb/III, III, and IV – Head and Neck, GI/GU, Breast, Endometrial, Liver, Renal
• Neurology, US and Global
o Phases II, IIb/III, III, and IV – ALS, Stroke, Alzheimer’s, Parkinson’s, Epilepsy
• General Studies, US and Global
o Phases II, IIb/III, III, and IV – Urinary, Quality of Life LANGUAGES SPOKEN (Please indicate skill level – basic/intermediate/fluent) Native language: English
PROFESSIONAL AFFILIATIONS
2007 – Present
SoCra, Certified Clinical Research Professional
PUBLICATIONS, ABSTRACTS AND PRESENTATIONS
Marathon and Half-marathon Participant Characteristics as Predictors of Hematologic, Injury, and Illness Outcomes (Runners' Science 2008), Michael Mohseni, Tiffany Goethe, Susan Sumrall, Journal of Medicine, 2007
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