Emily Randolph

-All responsibilities listed in Scientific Program Leader I listed below, plus:

• Assist with scientific concept development for future project funding
• Mentoring Scientific Program Leaders to ensure successful completion of program objectives
• Lead Program Manager for the 2024-2025 UL Flu Vaccine Effectiveness (VE) Network, to provide estimates of clinical effectiveness of licensed flu vaccines by age group and by influenza virus type and subtype
• Monitored program performance through regular evaluations, identifying areas for improvement and implementing necessary changes.

-Concurrently managing multiple NIH, CDC, and industry-based clinical trials (Phases I-IV), including:

• CDC Clinical Immunization Safety Assessment clinical trials (Phase IV): NCT03530124, NCT05007041, NCT05157191, NCT06038617
• Division of Microbiology and Infectious Disease (DMID) Vaccine and Treatment Evaluation Unit (VTEU) clinical trials: 16-0058 (Phase I PK Fosfomycin trial), 13-0053 (Phase I PK Safety of PA-824 trial)
• DMID Phase II COVID-19 Variant Immunologic Landscape Trial
• NIH Phase I/II RSV Vaccine trial in Children (DAIDS Study ID #38530
• NIH Division of AIDS (DAIDS) Phase I Study )HIV-1 Suppressed on Antiretroviral Therapy (NCT05604209)
• Site contact and lead for multiple COVID-19 & RSV Moderna and Pfizer clinical trials

-Manages all aspects of assigned clinical studies from study plan development to close-out

-Negotiating and facilitating site budgets and contracts

-Collaborate with finance administrators to track project spending and report financial highlights to the primary investigators

-Serve as the primary communication channel with external collaborators, sponsors, and subcontractors

-Draft project proposals, including operational requirements, pricing and schedules for projects

-Writing trial summary reports and drafting complex scientific presentations summarizing work for Scientific Advisory Board Meetings

-Leads protocol development and Manual of Procedures development

-Assists in development of study related documents, including Clinical Research Forms, Informed Consents, and Manuals of Operations

-Develop risk management plans and provide warnings of serious deviations or variations that may compromise programmatic deliverables

-Developing databases (i.e. REDCap) and working closely with biostatisticians to manage and review study analysis

-Overseeing Quality Assurance/Quality Control processes

-Collaborate with groups across Duke to monitor progress reports and milestones; coordinating processes to ensure contract reporting requirements are completed and submitted in accordance with the deadlines for each program

-Plan, lead, and facilitate regular cross-functional project team meetings.

-Develop detailed task lists and work effort assessment and short and long-term resource allocation plans based on input from all key players and team members

-DVTU floor warden/Safety Committee Member, communicating policies and procedures to employees during emergencies

-Managed all staffing/operations at the Duke Sleep Disorders Center for all shifts, 24/7, seven days a week

-Successfully re-accredited sleep center through the American Academy of Sleep Medicine (October 2018)

-Increased home sleep testing volume 202% from FY16 (July/2015 –June 2016) through FY19 (July 2018 –June 2019)

-Implemented hypoglossal nerve simulator therapy –Duke hospital first in NC to introduce new therapy

-Implemented new workflow process to allow for “chartless” documentation –allowing all PHI to be documented solely on Duke approve servers and on Epic for HIPPA compliance.

-Partnered with the Health Information Management department to load years of historical patient data into the patient’s electronic medical record.

-Implemented new workflow for patient billing to remain compliant with federal regulations

-Increased team leadership positions by 50%

-Project manager of the sleep lab renovation -9 day shut down. Collaborated with building contractors, medical equipment vendors, as well as Duke Hospital Infection control to maintain patient safety standards

-Implemented new safety protocols and equipment for patient and staff safety

-Managed operations/workflow on scheduled shift

-Direct patient care -performing all overnight sleep testing, including diagnostic, CPAP, BiPAP, ASV

-Handled interpersonal conflict and intervened when necessary to resolve issues

-Corrects and reports issues of missing/incorrect billing information

-Managed charge reconciliation process

-Continued to manage all activities listed under Polysomnographic Technologist I/II position

-Managed operations/workflow on scheduled shift

-Direct patient care -performing all overnight sleep testing, including diagnostic, CPAP, BiPAP, ASV

-Handled interpersonal conflict and intervened when necessary to resolve issues

-Corrects and reports issues of missing/incorrect billing information

-Managed charge reconciliation process

-Head chair of the departmental Policy/Procedure Committee – Ensuring policies in the lab are current and within AASM guidelines

-Successfully ensured that the Duke Sleep Disorders Center achieved re-accreditation in 2013

-Implemented and created a patient caregiver consent form to ensure safety for patients and technologists

-Successfully passed and obtained registry through the Board of Registered Technologists (BRPT) in 2011

-Performed overnight sleep studies, including diagnostic, CPAP, BiPAP, and ASV studies

-Scored sleep studies according to AASM guidelines

-Received multiple departmental patient recognition awards due to excellent service

-Recognized the need and implemented Spanish translated patient documentation for non-English speaking patients

-Successfully promoted to Polysomnographic Technologist II through the clinical ladder process in May 2012