Stephanie Patel
Hanahan,SC
Summary
Dynamic Program Delivery Manager at Johnson & Johnson Innovative Sciences with a proven track record in stakeholder management and process improvements. Expert in cancer therapy and project management, I streamlined study startup timelines by 50%, enhancing operational efficiency while fostering collaboration across cross-functional teams. Committed to delivering exceptional results in clinical research.
Overview
15
15
years of professional experience
Work History
Program Delivery Manager - Investigational Product (Site Investigational Product Specialist)
Johnson & Johnson Innovative Sciences
09.2024 - Current
- Established, built and sustained strong partnerships with stakeholders, including nurses, pharmacists, and investigators.
- Resolved complex Investigational Product issues as the main contact for cross-functional teams.
- Authored comprehensive IPPI documents to standardize product handling and administration.
- Championed process improvements, leading to increased operational efficiency.
- Facilitated workshops to promote teamwork and share best practices.
- Served as primary contact for cross-functional teams to resolve Investigational Product (IP) issues.
- Medical writing: Investigational Product Preparation and Administration Instruction (IPPI) to enhance best practices in IP handling, preparation, and administration.
- Managed diverse portfolio of advanced studies, sharing strategic insights with Global Development teams.
- Led initiatives related to IPPI and collaborated within working groups to ensure compliance.
- Conducted ongoing dialogues with customers to understand site perspectives on study drug preparation and administration.
- Provided consultation across cross-functional teams and business units to ensure the safe delivery of study drugs and documents at clinical sites.
- Executed organizational strategies to support continuous learning and operational improvements.
- Implemented process improvements, resulting in an increase in operational efficiency.
- Facilitated team meetings and workshops to foster collaboration and share best practices.
- Demonstrated behaviors consistent with the Leadership Imperatives, mentor and coach team members to improve their skills and contributions to the organization in collaboration with management.
CRA III/Site Investigational Product Specialist
ICON Clinical Research Sciences, formerly PRA Health Sciences
09.2020 - 09.2024
- Established productive relationships with internal and external stakeholders.
- Acted as the primary contact for cross-functional study teams regarding investigational product queries and issue resolution.
- Participated in nursing, pharmacy practice discussions, and scientific forums related to investigational products and clinical trial documents.
- Led onboarding and mentorship initiatives for new employees, enhancing integration into the team.
- Maintained diverse portfolio of complex studies, sharing insights with Global Development and special project teams.
- Directed IPPI-related initiatives and contributed to working groups focusing on investigational product improvements.
- Executed administrative tasks accurately and promptly, ensuring compliance with operational standards.
- Collaborated closely with clinical teams to support site assessments and training on investigational product administration.
Clinical Research Nurse/Department Manager
Charleston Oncology
Charleston, SC
05.2014 - 03.2020
- Directed clinical research program across primary and two satellite sites, managing over 100 trials including Expanded Access and Compassionate Use programs for 12 Principal Investigators.
- Established strong relationships with internal stakeholders, including clinical trial managers and medical science liaisons.
- Streamlined study startup timelines by 50% to a median of eight weeks and reduced treatment day violations by approximately 90% through implementation of new tools.
- Developed standard operating procedures for compliance with study sponsor protocols across various departments.
- Oversaw clinical monitoring quality and adherence to established plans and processes.
- Led bimonthly meetings with stakeholders to align goals, improve workflows, and discuss regulatory document transitions.
- Doubled clinical trial program revenue in first year, achieving consistent annual increases thereafter.
- Ensured patient safety and IRB compliance through informed consent processes and adverse event reporting.
- Coordinated communication between investigators, sponsors, vendors and other research personnel involved in the clinical trial process.
- Monitored laboratory results for trends that could indicate potential problems with study medications or treatments.
- Provided education to patients, families and healthcare providers about clinical trial protocols and informed consent process.
- Assisted with the preparation of regulatory documents for submission to appropriate agencies such as IRB and IEC or FDA.
- Monitored departmental budget, tracked trends, and negotiated sponsor budgets/contracts.
Infusion Nurse
Charleston Oncology
Charleston, SC
01.2013 - 05.2014
- Oversaw all aspects of patient care in infusion and injection suites.
- Administered chemotherapy and biotherapy daily for up to 12 patients.
- Conducted comprehensive patient assessments, including vital signs, and ECG.
- Calculated medication dosages and collaborated with medical personnel for necessary adjustments.
- Administered medications, maintained computerized charting, and completed treatment-related billing.
- Ensured proper infection control practices were followed throughout the entire infusion process.
- Managed multiple tasks simultaneously while maintaining attention to detail.
- Responded quickly and efficiently to emergency situations that occurred during an infusion procedure.
- Participated in continuing education programs related to advances in infusion practice standards.
- Mixed medications for chemotherapy and iron infusions, carefully following physician specifications.
- Performed blood and blood product transfusions and intravenous infusions to address patient symptoms or underlying causes.
- Educated family members about the importance of adhering to prescribed treatments for their loved ones receiving IV therapies.
Charge Nurse
Roper Saint Francis Hospital
Charleston, SC
01.2011 - 01.2013
- Oversaw comprehensive patient care, promoting teamwork and collaboration among staff.
- Managed care for five patients, including direct admissions, transfers, and discharges.
- Completed all required documentation and charting within established timelines.
- Collaborated with personnel to enhance patient care delivery and meet management expectations.
- Supervised nursing staff of two nurses and two patient care coordinators to ensure efficient operations.
- Collaborated with interdisciplinary teams to develop individualized care plans for patients.
- Provided emotional support for families facing difficult decisions regarding end-of-life care.
- Delegated tasks appropriately among staff members according to their qualifications.
- Managed staffing levels within the unit while ensuring optimal levels of patient care.
- Served as a preceptor for new nurses by providing orientation to unit policies and procedures, coaching on clinical skills, and mentoring on professional development issues.
- Coordinated communication between physicians and other healthcare professionals regarding patient care.
- Assisted with admission and discharge planning for assigned patients.
- Responded to emergency situations with speed, expertise and level-headed approaches to provide optimal care, support and life-saving interventions.
- Maintained strict patient data procedures to comply with HIPAA laws and prevent information breaches.
Education
Associate Degree - Nursing
Trident Technical College
Charleston, SC12.2010
Bachelor of Arts - Biology
College of Charleston
Charleston, SC08.1997
Skills
- Project management
- Cancer therapy expertise
- Microsoft Office applications
- Data analysis and communication tools
- Visual presentations and word processing
- Healthcare quality assessments
- Team leadership
- Stakeholder management
- Database management
- Delivery management
- Risk assessment
- Attention to detail
Accomplishments
- Inspire Award for support of EMR2 Program, 01/2025
- Inspire Award IPPI Process Improvement, 03/2025
- Inspire Award Foundational Training Material Review, 05/2025
- Imaavy (Nipocalimab) Health Authority Approval, 05/2025
Acknowledgments
- LKA Award for Nipocalimab Program, 12/06/21
- LKA Award - Janssen IPPI Department as SIPS, 12/20/21
- Mentor for SIPS, 2021
- Quality IPPI Process Audit, 02/01/22 - 03/01/22
- 2023 Thank you award recipient, 2023
- Mentor for SIPS, 2024
- LKA Award for Ancillary Supply Process, 07/01/24
- US Oncology Research Associate of the Month, 2015
- Top Recruiting Clinical Trial Site for US Oncology, 2014
- US Oncology Research Associate of the Month, 2014
- Oncology Nursing Society, Member, 2010 - Current
- Lambda Chi Nu Honor Society, Inductee & Member, 2010
- Student Nurses Association, Legislative Director, 2009 - 2010
Training
- Collaborative Institutional Training Initiative (CITI Program)
- US Oncology Research Good Clinical Practice (GCP) Training
- US Oncology CRC Core Curriculum
- HAZMAT Training
- Healthcity HIPAA/HITECH Training
- OSHA/Workplace Safety Training
Therapeutic Areas
- Hematology
- Oncology
- Immunology
- Neuroscience
- Infectious Disease - Phase I to Phase IV
- Solid Tumor Cancers/Carcinomas
- Bone Marrow Cancers
- Blood Disorders
- Supportive Care (Phase II to Phase IV)
- Registry and Observational Studies
- Compassionate Use/Expanded Access/Medical Affairs
Clinical Experience
- Medical University of South Carolina
- Roper Hospital
- Roper Saint Francis Hospital
- Palmetto Behavioral Health
Timeline
Program Delivery Manager - Investigational Product (Site Investigational Product Specialist)
Johnson & Johnson Innovative Sciences
09.2024 - Current
CRA III/Site Investigational Product Specialist
ICON Clinical Research Sciences, formerly PRA Health Sciences
09.2020 - 09.2024
Clinical Research Nurse/Department Manager
Charleston Oncology
05.2014 - 03.2020
Infusion Nurse
Charleston Oncology
01.2013 - 05.2014
Charge Nurse
Roper Saint Francis Hospital
01.2011 - 01.2013
Associate Degree - Nursing
Trident Technical College
Bachelor of Arts - Biology
College of Charleston