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Clinical Research

Location:
Mobile, AL
Posted:
December 10, 2023

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Resume:

BeatriceW.McDonald,BS,MBA

Mobile, AL ***** 251-***-**** ad1uv1@r.postjobfree.com www.linkedin.com/in/beatricemcdonald Analytical, organized and detail-oriented accountant with GAAP expertise and experience in the full spectrum of public accounting. In-depth knowledge and understanding of clinical procedures, study protocols, regulatory submission, informed consent, and documentation practices. Collaborative team player with ownership mentality and a track record of delivering the highest quality strategic solutions to resolve challenges, propel business growth. Skills/Core Competencies

GCP, Protocol, Data Entry, Accounts Payable, Accounts Receivable, Budget, administrative support, Clinical Research, Clinical trials, conferences, counseling, data collection, documentation, email, English, letters, meeting, patient safety, policies, presentations, protocols, reporting, SOP, multi-line telephone, travel arrangements, travel expenses reconciliation, fixed assets, bank reconciliation, month-end closing, journal entries, general ledger, posting, Phases I, II, III clinical trials, PSSVs, SIVs, IMVs, and COVs.

Technical Skills

MS Office (Word, Excel, Outlook, PowerPoint), Electronic Data Capture (EDC) System, ICH-GCP, Slack, Computer, Laptop computer, Fax, Multi-line telephone, Accounting, editing, financial, teaching, spreadsheets, technical writing, word processing, adaptability, collaboration, creative, emotional intelligence, Serious Adverse Event (SAE) reporting, Regulatory submissions, informed consent, documentation practices, Code of Federal Regulations (CFR) and DSCS Sweat Equity and Invest

Licenses and Certifications

• Clinical Research Associate Academy, Org.

• Protecting Human Research Participants (PHRP)

• ICH-GCP

• IATA

Experience:

Bioscience Technician/AIDT/Montgomery, AL / July 2023 – October 2023

• Ability to read and follow all written policies such as Standard Operation Procedures (SOP), Batch Production Records (BPR), Chemical Hygiene Plan, Emergency Contingency Plan, Material Safety Data Sheets (SDS), Specification Records, etc.

• Ability to write legibly and record data in accordance with Good Documentation Practices (GDP).

• Develop a general understanding of cGMP compliance and aseptic techniques as defined in company-specific training programs.

• Accurately perform operations such as weighing, measuring, sampling, and multi-step reagent or other solution preparation under direct supervision (eventually independently).

• Clean glassware and other laboratory equipment.

• Perform facility cleaning including sanitizing fume hoods, biological safety cabinets, clean rooms, isolators, etc.

• Report and address any problems and deviations.

• Transfer hazardous or nonhazardous waste materials to collection areas for disposal, recycling, or reuse.

• Active participation in deviation and/or CAPA (Corrective Action/Preventive Action) investigations. Accounting Specialist/Nations Roof, LLC/ Mobile, AL July 2022 – Present (Remote)

• Emailed/mailed out 3500 + invoices monthly.

• Handled billing disputes and prepared necessary journal entries to adjust and correct errors, issued credit memos or issue rebates.

• Ran detail aging report to cross reference all past due accounts for management.

• Managed and resolved customer inquiries.

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• Prepared journal entries for month end closing. Sort and coded customer payments analysis, tracking and updating daily deposits and reports.

• Cross reference payment activity through accounting system and excel to make sure it balanced. Clinical Research Associate/DSCS Sweat Equity & Investments, San Bernardino, CA October 2021 – November 2022

Phase 1 Dose-Escalation Study of Combination of Gedatolisib with Palbociclib and Faslodex in the Neoadjuvant Setting in Previously Untreated Patients with ER+/HER2-Breast Cancer (Remote monitoring).

• Conduct pre- site selection, initiation, monitoring, and close-out visits for research site according to the monitoring plan, PPD and Sponsor SOPs, ICH-GCP guidelines and applicable regulations.

• Review data queries, assist sites with query resolution and follow up on outstanding queries.

• Track and reports progress of study sites.

• Responsible for quality data from study sites.

• Provide training to site personnel.

• Verify that informed consent form procedure and protocol requirements are adhered to according to the applicable regulatory requirements.

• Identify and complete follow-up of SAEs at study site. Accounts Receivable Accountant/GLOBAL TEL LINK, Mobile, Alabama December 2019 – October 2020

• Emailed/mailed out 3500 + invoices monthly.

• Handled billing disputes and prepared necessary journal entries to adjust and correct errors, issued credit memos or issue rebates.

• Ran detail aging report to cross reference all past due accounts for management.

• Managed and resolved customer inquiries.

• Prepared journal entries for month end closing. Sort and coded customer payments analysis, tracking and updating daily deposits and reports.

• Cross reference payment activity through accounting system and excel to make sure it balanced. Accounting Tech/ Escambia County Commission, Pensacola, FL July 2018 – December 2019

• Efficiently process vendor invoices and maintain an up-to-date system.

• Created purchase orders and changed orders.

• Preparation and projection for the annual budget for the department.

• Reconciled employees Visa cards expense monthly.

• Wage verifications and reimbursement for contractual workers through vouchering payment.

• Performed presentations regarding financial planning. Loan Closer/Navy Federal Credit Union, Pensacola, FL September 2017 – July 2018

• Reviewedsalescontracts,addenda,homeowner’sinsurance,finalinspectiondocuments.

• Strong knowledge of various types of loans FHA, Conventional, ARM home loans.

• Figured APR and finance charges for home loans for RESPA and TIL compliance.

• HUD Settlement Statement for correct closing costs to wire funds to Tile Agency.

• Prepared and sent closing package via electronic and FedEx with instructions on how to sign the documents. Substitute Teacher/Escambia County School District, Pensacola, FL September 2013 – September 2017

• Provided positive behavior support with an emphasis on proactive solutions, development of coping mechanisms and antecedent control through the individualized development behavior plan.

• Delivered student instruction through lectures and demonstrations.

• Reinforced lectures with appropriate audio-visual aids to supplement oral instruction.

• Created a safe, positive, and supportive learning environment.

• Provided daily support, conflict resolution with staff through modeling and feedback.

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Accountant 1/Mobile County Commission, Mobile, AL August 2007 – April 2011

• Performed monthly bank and accounts reconciliations.

• Accounts Payable and Receivables.

• Created a new vendor identification account number for Account Payable Clerks.

• Maintained fixed assets and performed on-site / off-site annual physical count of assets.

• Placed surplus items on GovDeals.com for sale and received proceeds from sales and made deposit from sells. Page 3

• Work with external auditors during the audit review and compile all the necessary documentation required during the investigation.

Affiliations

Membership w/SOCRA May 2022

Education

MASTER BUSINESS ADMINISTRATION, FAULKNER UNIVERSITY December 2020 Major: Business Administration

BACHELOR OF BUSINESS ADMINISTRATION, FAULKNER UNIVERSITY DECEMBER 2005 Major: Business Administration

ASSOCIATE IN APPLIED SCIENCE IN ACCOUNTING, BISHOP STATE COMMUNITY COLLEGE MAY 2001 Major: Accounting

Reference Available Upon Request



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