SUMMARY

A highly experienced certified clinical research Associate Principal, Site Payment Specialist, with considerable global experience within the CRO/Pharmaceutical/Medical Devices communities. Key experiences are within hematology, oncology, cardiovascular, neurology, general studies areas.

EXPERIENCE

Date: From Jul 2023 to Present

Company Name: Premier Research

Job title: Associate Principal, Site Payments Specialist

Schedules and leads kick-off meetings (KOM)

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 in 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 retrieving 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 and CROs to review the study status and to address any issues/concerns

Reviews and tracks remaining balance of the purchase order

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

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, counselling, 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 documents for allocated regions 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.

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

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

Date: From Dec 2019 to Dec 2020

Company Name: Centene Corporation

Job title: Program Coordinator

Completed 701b state assessments for Broward County, Florida Medicaid contract participants

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.

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 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 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.

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.

Date: From Feb 2007 to May 2012

Company Name: Mayo Clinic

Job title: Protocol Development Coordinator/Masters Level Study Coordinator

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.

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 CRA

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/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 submit 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.

THERAPEUTIC EXPERIENCE

Therapeutic Area & Phase

Cardiovascular, US and Global

oPhases II, IIb/III, III, and IV – Hypertension

Hematology, US and Global

oPhases I, Ia Ib, II, IIb/III, III, and IV – MM, Leukemia, Lymphoma, Sickle- Cell Anemia,

Oncology, US and Global

oPhases I, Ia, Ib, II, IIb/III, III, and IV – Head and Neck, GI/GU, Breast, Endometrial, Liver, Renal

Neurology, US and Global

oPhases II, IIb/III, III, and IV – ALS, Stroke, Alzheimer’s, Parkinson’s, Epilepsy

General Studies, US and Global

oPhases II, IIb/III, III, and IV – Urinary, Quality of Life

EDUCATION

Year: 2010

Master of Business Administration and Finance, Capella University, Minneapolis, MN

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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