Summary
Overview
Work History
Education
Skills
References
Timeline
Generic

Gina Stefanelli

Hampstead,NC

Summary

Enthusiastic Lead Sr. GCTA with 3+yrs of experience on the sponsor side across multiple TA’s, through all study phases, both in-house and outsourced. I am eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Some of my responsibilities include meeting minutes, documents and communication distribution to the team, running weekly reports ensuring all metrics are compliant, maintaining EDL completeness within VTMF, vendor shipment requests and tracking. I prepare and lead the AQR (annual quality review) and ensure all FA’s have completed their review before the due date. I support with the upload and distribution of site staff training. I am motivated to learn, grow, and excel in Clinical Trial Research by taking on new tasks which allow me to grow and learn. By working closely with the GTL and CTM’s. I am able to support with meetings, distributions to the team and be included in other functional areas. I am involved in the VTMF Champions group along with the GCTA Leadership program. Willingness to take on added responsibilities to meet team goals. Quick learner with great people skills and focus on problem-solving. Handles complex assignments without complaint and works great under pressure. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Overview

21
21
years of professional experience

Work History

Sr. Global Clinical Trial Associate

ICON PLC
04.2021 - Current
  • Implemented comprehensive quality control measures to ensure accurate data collection and reporting across all aspects of the study.
  • Supported the successful completion of all study milestones by proactively identifying potential challenges and implementing well-coordinated action plans to address them.
  • Cultivated productive working relationships with key opinion leaders in the field to enhance scientific credibility and promote trial awareness among stakeholders.
  • Served as a key liaison between investigative sites and study sponsors, ensuring prompt communication of updates, concerns, or requests.
  • Increased study efficiency through meticulous tracking of key performance indicators and prompt resolution of any issues identified.
  • Supported timely patient enrollment by proactively addressing potential barriers and utilizing strategic communication methods.

Office Manager/Dental Assistant

Southampton Dental
01.2004 - 03.2021
  • Handled sensitive information with discretion, maintaining confidentiality of company documents and personnel records.
  • Provided exceptional customer service when addressing client inquiries or concerns via phone calls or email correspondence.
  • Maintained accurate financial records by reconciling accounts payable/receivable transactions regularly to ensure balanced budgets.
  • Developed and maintained successful relationships with vendors, suppliers and contractors.
  • Oversaw office inventory activities by ordering and requisitions and stocking and shipment receiving.
  • Managed office operations while scheduling appointments for department managers.
  • Assisted in the recruitment process, conducting interviews and onboarding new employees to promote a seamless integration into the team dynamic.
  • Cleaned and sanitized dental tools and equipment, straightened treatment rooms, and restocked supplies to prep for next patient and maintain health and safety practices.
  • Provided chairside assistance during examinations, improving dentist efficiency and patient satisfaction.
  • Successfully assisted dentist by performing four-handed dentistry and other chair-side duties.
  • Assisted dentists with complex procedures, ensuring optimal patient care and treatment outcomes.
  • Documented patient dental health information, medical history, and vital signs for future reference.

Education

Master of Science - Hospitality Administration And Management

Widener University
Chester, PA
05.2000

Skills

  • Trial Oversight
  • Vendor Oversight
  • TMF Maintenance
  • CTMS
  • Central lab coordination
  • Training and mentoring
  • Good Clinical Practices
  • EDC Rave
  • Communication and collaboration
  • Good Documentation Practice
  • ICH-GCP
  • Proficient in Excel, MS Office Suite and SharePoint
  • Leadership
  • VTMF Champion
  • GCTA Leadership Program

References

Available upon request

Timeline

Sr. Global Clinical Trial Associate

ICON PLC
04.2021 - Current

Office Manager/Dental Assistant

Southampton Dental
01.2004 - 03.2021

Master of Science - Hospitality Administration And Management

Widener University
Gina Stefanelli