STEPHANIE BABEY
803-***-**** · ad2cfj@r.postjobfree.com · Spartanburg, SC 29304
A business professional exploring new endeavors, with a keen ability to analyze complex data and develop effective solutions to problems. Systematic team leader with experience in managing and leading cross-functional teams. Experienced in managing budgets and allocating resources. Skilled in creating and implementing innovative ideas and strategies to deliver products and services that exceed client expectations.
Experience:
Entrepreneur/ Entertainment Business Owner
ENORAS CORNER LLC, Columbia, SC
January 2020 - Present
• Analyzed market trends and competitor data to develop competitive pricing strategies.
• Developed and implemented a successful marketing strategy to increase brand awareness and customer base.
• Directed administrative activities related to making products or supplying services.
• Designed innovative approaches to optimize workflow, streamline procedures, and enhance customer service satisfaction levels.
• Set and implemented strategic goals and initiatives to align the company with its mission, values, and vision.
• Full decentralization.
Senior Clinical Research Site Manager III
PAREXEL INTERNATIONAL, Durham, NC
December 2018 - January 2020
• Performed monitoring visits to clinical sites to review source documents, case report forms, and other pertinent documents per ICH-GCP guidelines.
• Addressed and resolved client or customer inquiries to foster superior standards of service.
• Facilitated month-end closing processes, invoicing, and journal entries.
• Represented business in the marketplace and developed relationships with key accounts to promote and market business.
• Conducted site qualification visits, initiation visits, interim monitoring visits, closeout visits, and regulatory document reviews.
• Hybrid role with full decentralization.
Clinical Research Site Monitor II
PAREXEL INTERNATIONAL, Durham, NC
September 2016 - December 2018
• Monitored inventory levels at job sites regularly to prevent shortages or overages of supplies.
• Conducted risk assessments of tasks being performed at the job site and provided recommendations for mitigating risks if necessary.
• Participated in incident investigations as required by company policy.
• Performed regular audits of the premises to identify areas where improvements can be made regarding safety protocols.
• Assessed and monitored the safety of site personnel, equipment, and visitors to ensure compliance with regulations and standards.
• Hybrid role with full decentralization.
Clinical Research Site Monitor I
PAREXEL INTERNATIONAL, Durham, NC
December 2010 - September 2016
• Tracked progress of each study by reviewing enrollment numbers regularly; provided updates as needed.
• Developed comprehensive knowledge of Good Clinical Practice guidelines and regulations to ensure compliance with study protocols.
• Identified discrepancies between source documentation and the database entries; worked closely with investigators to resolve any issues promptly.
• Prepared regulatory submissions for Ethics Committees or IRBs to obtain approval before conducting clinical trials.
• Collaborated with internal teams such as Data Management, Quality Assurance, Drug Safety, and Biostatistics, as necessary.
• Managed logistics associated with the shipment of investigational products from warehouses or sponsors directly to clinical sites.
Education:
Associate in Arts (A.A.) in Liberal Arts
Southern New Hampshire University, Manchester, NH, US
• Humanities /Behavioral Studies
Associate in Science (A.S.) in Computer Science
Katharine Gibbs School of Business, New York City, NY, US
• Digital Communications & Business Administration Skills:
• Team Development • Continuous Quality Improvement (CQI)
• Database Management System Software • Customer Acquisition
• Site Investigations • Business Planning
• Personnel Management • Conversational Spanish
References:
References are available upon request.