Callie Arnold
Director
Summary
Strategic, organized Director with talents for team building, leading and motivating, as well as excellent customer relations aptitude and analytical problem-solving skills. Talented at performing detail-oriented inspections and training employees for excellent service. Accomplished at identifying deficiencies and initiating solutions to problems. Dedicated to maintaining both superlative quality and excellent employee morale.
Overview
18
18
years of professional experience
4
4
Certifications
Work History
Site Director
Accelerated Enrollment Solutions
Orlando, FL
03.2021 - 06.2023
- Managed the largest clinical research site within the AES/PPD global network of 160+ sites. Orlando site comprised of 4 clinics, including a Phase 1 clinic, and over 100 staff members
- Personnel management duties included interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations
- Planned for the appropriate study conduct and staffing resources to ensure a successful workflow (including recruitment, clinical conduction, and client deliverables)
- Served as a KOL (Key Opinion Leader), for Site Directors and Senior Leadership across the organization, on several topics including increasing morale and employee performance, quality improvement, regulatory inspections, and ethical conduct of research
- Oversaw numerous FDA Inspections and Sponsor Audit Engagements resulting in favorable outcomes and zero significant findings
- Prepared budgets and forecasts, scheduled project tasks, allocated resources to team members, and monitored projects to ensure they were completed on time and under budget
- Conducted process and system audits to identify areas of improvements and enforce compliance with the company quality framework (QA/GCP), regulatory (GCO) legislation, guidelines, and international standards (Global/Local COPS/SOPS)
- Developed and implemented comprehensive quality assurance policies to monitor data collection, resulting in >80% reduction in data entry delays and queries within the first 3 months
- Worked with the Global Senior Compliance team to create and/or rewrite several organizational documents, including national and global SOPs
- Utilized effective communication skills to positively motivate and influence clients, colleagues and direct reports
- Collaborated with cross-functional teams to increase site-level financial visibility, local study selection and recruitment campaigns, resulting in improved quality and increased efficiencies
- Built and maintained strong relationships with internal and external partners.
Clinical Research Manager
AdventHealth Hospital
Orlando, FL
05.2017 - 02.2021
- Managed the COVID/Critical Care Research Department, created in response to the COVID pandemic
- Trained and supervised a remote team, comprised of coordinators, data entry staff, and research assistants
- Selected and oversaw the development of new staff including investigators and regulatory staff
- Complied with research protocols by providing ongoing quality control audits to ensure compliance with applicable regulations; provided leadership support in identifying and implementing corrective actions/processes
- Developed and implemented processes, including marketing strategies, for identifying and recruiting potential subjects for studies
- Provided effective clinical study management; including planning, organizing, and managing all activities related to clinical operations and execution of timelines
- Worked closely with both central and local IRBs to ensure the implementation of approved protocols
- Completed entire study lifecycle, from start-up, through execution, and close-out
- Collected and organized research data, patient schedules, and performed clinical tasks (i.e., ECG, Vital Signs, phlebotomy, and processing)
- Created source documents, Case Report Forms, tracking sheets, referral letters, and study eligibility forms
- Conducted monthly and quarterly meetings involving research team members, clinic staff, and physicians to review outcomes, patient enrollment, areas for improvement, and upcoming studies.
Account Finance Manager/Research Coordinator
AES/PPD
Orlando, FL
09.2013 - 04.2017
- Executed and coordinated daily Protocol specific clinical research activities according to SOP, GCP, and FDA/ICH guidelines
- Supported operations management, sales, and marketing efforts to increase revenue and overall financial health
- Trained new and existing staff members in financial responsibility when conducting/completing subject clinical visits and data accuracy
- Attended Investigator Meetings and networked with pharmaceutical companies, sponsors, and certified research professionals
- Strengthened communication with other departments to enhance recruiting and retaining eligible patients for enrolling and future studies
- Worked on various trials including general medicine, pain, and neurological indications at Phases 1 to 4
- Maintained and dispensed investigational products and reconciled investigational accountability logs
- Monitored budget and revenue trends, compiling reports for company leadership to inform decision-making
- Cross-Functional accounting and finance duties, including Clinical Conductor Study Builds, Accounts Receivables/Payables, Budgets, Contracts, and Protocol/Budget Amendments
Accountant
Ruth's Hospitality Group, Inc
Winter Park, FL
05.2011 - 08.2013
- Performed audit and accounting functions for over 80 national restaurants and 20 global franchises
- Executed financial reporting, managing prepaid accounts, schedules, reconciliations, event settlements, and month-end accruals
- Participated in internal and external audit processes to establish accurate financial records and comply with Generally Accepted Accounting Principles and regulatory requirements
- Aided in preparing budgets and forecasting expenses and costs to make informed decisions regarding future financial performance
- Maintained fixed asset records and depreciation schedules to establish accurate calculations
- Documented cash, credit, fixed assets, accrued expenses, and line of credit transactions
- Monitored accounts receivable, accounts payable and other account balances to track transactions, avoid discrepancies and maintain accuracy
- Diminished outstanding debts by analyzing accounts for issues
- Prepared working papers, reports and supporting documentation for audit findings
- Initiated comprehensive account assessments to check viability, stability, and profitability of business operations
Accountant
Liberty Investment Properties, Inc.
Maitland, FL
06.2008 - 06.2011
- Reconciled accounts and reviewed expense data, net worth, and assets.
- Documented cash, credit, fixed assets, accrued expenses, and line of credit transactions.
- Completed daily cash functions like account tracking, payroll and wage allocations, budgeting, donating, and cash, and banking reconciliations.
- Handled day-to-day accounting processes to drive financial accuracy.
- Partnered with auditors to track errors and add contributions to maintain accuracy.
- Initiated comprehensive account assessments to check viability, stability, and profitability of business operations.
Marketing Director
Holland Pools & Spas, Inc.
Longwood, FL
01.2005 - 05.2008
- Boosted brand awareness and generated leads while managing internal and external marketing campaigns and programs.
- Devised marketing plans using digital strategies, print advertising, and word of mouth tactics.
- Created innovative strategies to drive customer engagement.
- Coordinated with creative team to generate dynamic marketing content and communication tools for promotional campaigns.
- Secured long-term accounts by recommending strategies to promote brand effectiveness and highlight product benefits.
- Planned and executed events and marketing programs to increase qualified leads.
Education
Bachelor of Science - Finance
Florida Southern College
Lakeland, FL 08.2007 - 2009.05
Bachelor of Science - Marketing
Florida Southern College
Lakeland, FL 08.2007 - 2009.05
Associate's Degree - Business Administration And Management
Seminole State College
Sanford, FL 06.2002 - 2005.12
Skills
Policy Development
Affiliations
- Association of Clinical Research Professionals
- International Society of Female Professionals
Certification
Certified Clinical Research Coordinator
Timeline
Site Director
Accelerated Enrollment Solutions
03.2021 - 06.2023
Certified Clinical Research Coordinator
05-2017
International Air Transport Association
05-2017
Clinical Research Manager
AdventHealth Hospital
05.2017 - 02.2021
Basic Life Support
09-2013
Account Finance Manager/Research Coordinator
AES/PPD
09.2013 - 04.2017
Accountant
Ruth's Hospitality Group, Inc
05.2011 - 08.2013
Accountant
Liberty Investment Properties, Inc.
06.2008 - 06.2011
Bachelor of Science - Finance
Florida Southern College
08.2007 - 2009.05
Bachelor of Science - Marketing
Florida Southern College
08.2007 - 2009.05
Notary Public, Florida
04-2005
Marketing Director
Holland Pools & Spas, Inc.
01.2005 - 05.2008
Associate's Degree - Business Administration And Management
Seminole State College
06.2002 - 2005.12
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