April Smith Email & Phone Number

Nashville, Tn, Us

Nashville, Tn, Us

• Shape and execute TA / DAS / Program / Trial level programmatic, patient and site engagement strategies in support of overall PSE and/or DEICT plan in partnership with regional and country teams• Collaborate with site-facing roles on site-facing activities to obtain insight for the tailoring of fit-for purpose plans and tactics• Create site-facing materials and train site-facing teams throughout the end-to-end process• Manage recruitment timelines to meet the local submission process and maintain documentation of recruitment development and implementation requirements to ensure quality standards are met• Identify and provide Key Performance Indicators (KPI) and conduct Return on Investment (ROI) analysis to determine the effectiveness of recruitment and engagement strategies and tactics• Train and support individual study teams across the portfolio in developing a diversity plan, ensuring equitable access to Janssen studies• Contribute to protocol design to incorporate patient and site voice and local insight

•Operationalized data-driven global recruitment, retention, and site engagement strategies for 10 phase Ib, II, and III clinical trials in the oncology indications of lung and bladder•Supported the development of patient and site trial-specific resources, served as the primary contact for the management, execution, and timely delivery of these solutions, and managed oversight of external vendors in support of clinical trial recruitment and retention•Facilitated internal review and approval of patient and site tactics, management of the tactics in VTMF, and maintained oversight of local IRB/EC tactic approvals•Developed study dashboards to proactively monitor study screening, enrollment, and retention rates at the global, country, and site level•Evaluated global, country and site level recruitment and retention metrics and implemented responsive mitigation strategies for any identified issues•Provided focused recruitment and retention support for local teams in priority countries•Independently drove the update and implementation of vendor template ICF language to improve utilization of vendor services, requiring coordination with multiple internal and external teams•Identified gaps in budget management and forecasting processes leading to the development and implementation of a programmatic training for Patient & Site Engagement functions

Nashville, Tennessee, United States

•Completed detailed evaluation of patient status, tumor type, and mutational profile against trial-specific eligibility criteria, based on slot availability and IP mechanism of action from trial menu of 160+ early phase trials•Executed education and medical management of 8-16 patients per month from initial visit through C1D1 of trial, including administration of informed consent forms and completion of all screening assessments per protocol requirements, with a specific focus on patients with lung or head & neck cancers•Represented the nursing team at SIVs and developed protocol specific education materials to support the enrollment nursing team in identifying appropriate patients for upcoming new trials •Exceeded position requirements by providing trial suggestions to physicians for their patients based on current slot availability, oncologic diagnosis, mutational profile, and IP MOA•Implementation of new team structure to streamline eligibility reviews, resulting in more timely identification and enrollment of patients to trials and increased physician satisfaction

Nashville, Tennessee

•Evaluated and interpreted study protocols, completed protocol required procedures, assessed and documented AEs/DLTs/SAEs/AESIs, and managed medical care of patients from C1D1 through duration of their participation in early phase clinical trials for lung, head & neck, CRC, breast, and ovarian cancers•Developed a competency assessment for new clinical research nurses to test knowledge of protocol interpretation based on real-world potentials for enrolled participants•Implemented a SIV nurse education process to ensure colleagues were appropriately trained on investigational products, protocol requirements, and medical management of enrolled participants for upcoming clinical trials•Exceeded position requirements and provided support to the Enrollment Nursing Team with patient eligibility reviews during a time when their team capacity was low

Nashville, Tennessee

•Managed the care of 4-6 neuro and ortho patients per shift at a leading Level 1 Trauma Center and Comprehensive Stroke Center while providing safe, competent, and professional nursing care to attain optimal patient outcomes.•Skills required to perform successfully include effective collaboration interdisciplinary team members, efficient time management, and effective prioritization.