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Work Background
Manager of Research Operations | Grant Administrator
Medical University of South CarolinaManager of Research Operations | Grant Administrator
Apr. 2024Charleston, South Carolina Metropolitan Area• Provide Pre-Award leadership through the review of grant proposals, applications, and contracts to ensure completeness and compliance with related agencies and affiliates. • Advise investigators in the planning and submission of grant applications, project agreements, contracts and subcontracts. • Assist in the compiling of information required for applications, contacting funding agencies and institutional offices, and coordinating the overall development of applications and contracts. • Responsible for Departmental post-award financial leadership through the research administration team’s management of awarded grants to ensure accurate and appropriate financial activities. • Serve as the leader and departmental liaison with key organizational research partners including Principal Investigators, Office of Research and Sponsored Programs (ORSP), Grant and Contracts Accounting (GCA), and the Office of Clinical Research (OCR). • Partner with the Manager of Research Analytics on PI and Departmental reporting best practices. Collaborate with the Pediatric Research Group Manager and Director of Research Administration on strategic planning and operations of clinical research activities.
Director of Clinical Research
Coastal Pediatric AssociatesDirector of Clinical Research
Jan. 2024 - Apr. 2024Charleston, South Carolina, United States
Owner
JMB Consulting, LLCOwner
Jun. 2021Charleston, South Carolina Metropolitan AreaAt JMBC, I specialize in optimizing the operational efficiency of clinical research sites with a specialty in pediatric studies. I bring a wealth of experience in managing and streamlining clinical trials, ensuring that your site adheres to the highest standards of quality and compliance while addressing the unique challenges of pediatric research. I offer a comprehensive suite of services, including site management structure, financial contract and budget negations, regulatory compliance, quality assurance and control, patient recruitment and retention strategies, approaches to study feasibility, guidance for site financial health and compensation models, and data management. The tailored solutions are designed to enhance site performance, improve patient outcomes, and accelerate the advancement of pediatric therapies. Through our partnership, clinical research sites gain access to specialized knowledge and best practices in pediatric research operations, empowering them to deliver exceptional results in a field that demands precision and compassion.
Clinical Research Financial & Regulatory Manager
Coastal Pediatric AssociatesClinical Research Financial & Regulatory Manager
Oct. 2017 - Jan. 2024Charleston, South Carolina, United States• Operational Responsibilities o Management of quality, regulatory, finance, and study coordinators (approximately 20-25 staff); develop plans and goals for study delivery, promoting mentorship and diversity in trial assignments for career development o Delegated phlebotomist on all pediatric studies; act in a back-up coordinator capacity as needed o Maximize clinical trial delivery process efficiency and regulatory compliance on a company-wide scale and delegate staff to support functions o Reorganized project-specific training and coordinator orientation; determine resources and methodologies required for staff and study success with KPIs and collaboration with other departments within the practice o Lead, and participate in, training development efforts for new systems and problem-solving interoperability where applicable • Financial Responsibilities o Budget and contract development, including preparation and negotiation with study Sponsors. o Compile and report monthly financial statements and metrics for forecasts and budgeting o Created variable compensation calculations and allocated distributions. o Participate in long-term financial and strategic planning. o During COVID-19, acted as interim Senior Director of Finance to the pediatric practice and research division to manage $28 million in receivables. • Regulatory Responsibilities o Perform quality assurance and control on subject visits, data completion, and regulatory compliance for over 75+ active trials across four locations. o Manage the development and enforcement of the Coastal Pediatric Research Quality Management Program with formal QA report and metrics for staff and study evaluation o Manage and write site Standard Operating Procedures; provide training on revisions. o Provide ongoing development of protocol site workflows and staff continuing education on regulations; o Manage web-based clinical trial management and regulatory systems as site super-user
Clinical Research Financial & Regulatory Analyst
Coastal Pediatric AssociatesClinical Research Financial & Regulatory Analyst
Apr. 2016 - Oct. 2017• Responsible for clinical research budget and contract development including preparation and negotiation with study Sponsors • Analyzed protocol required events to determine appropriate clinical procedures to be used for budgeting • Maintained and ensure that all documentation is in a state of audit readiness across 10+ investigator site files in three locations • Compiled and reported quarterly budgeted research finances for forecasts • Assisted with day-to-day research activities • Acted in a back-up coordinator capacity for over 20+ active trials
Practice Administrator
Access Healthcare, LLCPractice Administrator
Jun. 2015 - Apr. 2016• Managed downtown office staffing and operations • Controlled daily maintenance of IT, planning and implementation of new technology, systems and workflows —-Redesigned the workflow for patient handouts in current EMR • Analyzed and reported revenue collections, accounts payable, payroll, tax records, and year-end practice analytics • Contributed to 5% growth in patient volume, equating to a 22% increase in revenue for from FY2014 to FY2015 • Re-evaluated services provided and expanding staff functions for a strategic growth of a second practice • Researched and successfully implemented a new phone system to improve the workflow for routing calls appropriately • Introduced sclerotherapy as a new provided service, and designed fee structure for additional revenue
Administrative Intern
Access Healthcare, LLCAdministrative Intern
Jan. 2015 - May. 2015Charleston, South Carolina
OCAO Intern
Medical University of South CarolinaOCAO Intern
Sep. 2014 - Apr. 2015•Building and optimizing Tableau© reports using SQL server and EPIC to manage operational performance metrics within the perioperative arena •Working constructively with clinical staff to operationalize the analytics and facilitate data-influenced change
Administrative Intern
Ralph H Johnson VA Medical CenterAdministrative Intern
Apr. 2014 - Apr. 2015charleston area, south carolinaDepartment of Nursing and Patient Care Services •Educated nurse managers on labor mapping changes to improve productivity using the derived clinical-financial system, dSS (Decision Support System) •Created a “stoplight” standardized approach to certify labor mapping changes on a monthly basis for nurse managers •Organizing a LEAN process for implementation and evaluation of Project RED© (Re-Engineered Discharge), collecting baseline data and operationally defining measures •Drafted proposals and memorandums to inform Labor Union Representatives regarding Project RED© •Redesigning Nursing SharePoint site to make the site a more user-friendly and better utilized platform for communication and file-sharing
Graduate Intern
Medical University of South Carolina College of MedicineGraduate Intern
Jan. 2014 - Apr. 2014Department of Pathology •Audited specimens and mapped processes of two frequent types of specimens from accessioning to billing •Analyzed the timing of technical and professional fees billed; technical fees averaged 1 day following case sign-out; professional fees averaged 30 days following case sign-out •Provided recommendations to ensure workload was captured and reduce waste
Research Assistant
Medical University of South CarolinaResearch Assistant
Nov. 2013 - Jan. 2015Research assistant for Antiepileptic Monitoring Project.
Office of Alumni Relations Intern
Washington & Jefferson CollegeOffice of Alumni Relations Intern
Sep. 2012 - May. 2013• Coordinated with students and alumni, matching compatible pairs for the Alumni-Mentor Program and its networking capabilities • Wrote monthly articles for the alumni eNewsletter, specifically focusing on student and Greek organization spotlights • Wrote Alumni-Mentor articles between protégés and mentors for the promotion of the Alumni-Mentor program • Drafted a proposal and student representative description to create a Volunteer Program conducted through the Office of Alumni Relations
Maternal Child Deparment Intern
Licking Memorial HospitalMaternal Child Deparment Intern
May. 2012 - Jan. 2014newark, oh• Assisted lactation consultant in collecting data for the Breastfeeding Promotion & Support Program, focusing on duration and exclusivity • Created survey questions for data collection based upon time returning to work, and compared data with duration of breastfeeding, observing the support mothers received upon returning to work. • Assisted lactation consultant with producing a booklet for the launch of their Tobacco Cessation Program, encouraging new and expecting mothers to quit smoking. • Audited records, looking at vitals trends in special-care nursery infants with effective kangaroo care. • Audited records for Neonatal Abstinence Scores and regiments for drug withdrawal for Nationwide Children's Hospital's (Columbus, Ohio) data collection, encompassing multiple hospitals throughout central Ohio.
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