Allison Warner Leadley
Golisano Children's Allergy and Immunology
Pittsford
20
years of professional experience
Healthcare professional with more than 30 years of experience in clinical research, academic medicine, and healthcare operations within a large academic medical center. Extensive background in patient interaction, informed consent, interdisciplinary collaboration, regulatory compliance, quality improvement, and clinical trial management. Experienced leader with a proven record of supervising research teams, mentoring staff, and managing complex projects across multiple specialties. Completing an accelerated Bachelor of Science in Nursing at the University of Rochester and eager to apply strong clinical judgment, communication, and evidence-based practice as a registered nurse.
Work History
Senior Clinical Human Subject Research Specialist
4 Years 10 Months- Manage multiple NIH funded pediatric clinical trials.
- Lead site initiation, monitoring, audit, and close-out visits while ensuring compliance with GCP, FDA, and institutional requirements.
- Oversee participant recruitment, informed consent, study visits, specimen collection, and electronic data capture.
- Collaborate with physicians, nurses, laboratory personnel, CTSI, and external sponsors to ensure seamless coordination of study activities.
- Supervise research coordinators, administrative staff, and student employees, providing mentorship and support to enhance workflow and team effectiveness.
- Assist investigators in developing protocols, preparing grants, and facilitating investigator-initiated research projects.
Clinical Program Manager, Patient Reported Outcome
4 Years 3 Months- Led enterprise-wide implementation of Patient Reported Outcome Measurement Information System (PROMIS) across UR Medicine.
- Collaborated with executive leadership, physicians, nursing, and information systems to integrate PROMIS into clinical workflows, enhancing efficiency and patient engagement.
- Developed training materials and trained clinical teams on PRO adoption and implementation.
- Managed multidisciplinary projects aimed at increasing patient engagement and driving quality improvement initiatives.
Senior Health Project Coordinator
6 Years- Supervised six research coordinators overseeing 100+ active clinical studies to ensure quality and compliance.
- Managed investigational products while ensuring adherence to regulatory standards and accountability.
- Conducted informed consent and participant education.
- Monitored adverse events and reported to regulatory agencies.
- Developed study budgets, timelines, and feasibility assessments.
- Ensured compliance with GCP, FDA regulations, and institutional policies.
- Prepared studies for sponsor audits and monitoring visits to facilitate compliance and operational integrity.
Health Project Coordinator
4 Years 6 Months- Coordinated maternal-fetal nutrition research with Cornell University and University of Rochester, contributing to multidisciplinary knowledge advancement.
- Coordinated participant visits, specimen collection, cord blood collection, and placenta processing to ensure comprehensive data gathering for research.
- Maintained study databases and supported publications and literature reviews to enhance research dissemination and academic contributions.
Education
Bachelor of Science in Nursing
Masters in Public Health - Clinical Research/Maternal & Fetal Health
Bachelor of Science - Biology
Skills
Informed consent discussions
Patient assessment and education
Venipuncture (phlebotomy)
Research medication dispensing and accountability
Specimen collection and processing
Interdisciplinary collaboration
Clinical documentation (EPIC/eRecord)
IRB submissions
Adverse event reporting
Quality improvement
Staff supervision and mentoring
Budget development
Timeline
Senior Clinical Human Subject Research Specialist
Golisano Children's Allergy and Immunology
10.2021 - CurrentRead More
Clinical Program Manager, Patient Reported Outcome
URMC Medical Faculty Group
06.2017 - 09.2021Read More
Senior Health Project Coordinator
University of Rochester Department of Orthopaedics
05.2011 - 05.2017Read More
Health Project Coordinator
University of Rochester Strong Midwifery Group
10.2006 - 04.2011Read More
University of Rochester School of Nursing
Bachelor of Science in Nursing
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University of Rochester School of Medicine
Masters in Public Health from Clinical Research/Maternal & Fetal Health
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Cornell University
Bachelor of Science from Biology
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