Alicia Y. Greene

Coordinate clinical trial start-up and ongoing site management across studies sponsored by Merck, Exelixis, Roche, Arcus Biosciences, and investigator-initiated programs. Lead regulatory operations and IRB submissions, including FDA Form 1572s, investigator credentials, laboratory certifications, protocol signatures, amendments, annual renewals, and PI changes. Partner with PIs, CRAs, Clinical Team Leaders, Project Managers, sponsors, and investigative sites to maintain study timelines, protocol compliance, and operational readiness.

Senior Research Program Coordinator II – GU Oncology - Johns Hopkins University - Baltimore, MD

(2025)

• Coordinate clinical trial start-up and ongoing site management across studies sponsored by Merck, Exelixis, Roche, Arcus Biosciences, and investigator-initiated programs.
• Lead regulatory operations and IRB submissions, including FDA Form 1572s, investigator credentials, laboratory certifications, protocol signatures, amendments, annual renewals, and PI changes.
• Partner with PIs, CRAs, Clinical Team Leaders, Project Managers, sponsors, and investigative sites to maintain study timelines, protocol compliance, and operational readiness.
• Oversee data quality and study documentation through OnCore, case report form review, query resolution, site-file quality control, reporting, and action-item tracking.

Senior Research Program Coordinator II - Adult Pulmonary - Johns Hopkins University - Baltimore, MD

• Acted as lead coordinator and co-investigator for five international Phase I–IV clinical trials, including first-in-human studies spanning infectious disease, oncology, and endocrinology.
• Managed study budgets and invoicing exceeding $80,000 while supporting protocol, SOP, site-feasibility, informed-consent, CRF, and data-management development and review.
• Directed recruitment, enrollment, retention, regulatory activities, protocol implementation, data management, pharmacovigilance, and study timelines from start-up through study completion.
• Managed full cycle recruiting, provided ongoing guidance to junior research staff, and served as a protocol and subject matter expert at investigator meetings.

Senior Research Program Coordinator I - Endocrinology - Johns Hopkins University - Baltimore, MD

(2003)

• Acted as lead coordinator of Medtronic implantable insulin pump studies and investigator-initiated research programs.
• Managed study budgets, invoicing, regulatory start-up, IRB documentation, and ongoing regulatory maintenance.
• Directed patient recruitment, study visits, informed consent, patient education, data collection, and research documentation to support efficient study execution.

Johns Hopkins Carey School of Business - Academy for Healthcare Leadership and Management

Academy for Women and Leadership

Bachelor of Science - Business Management - Monmouth University