Experience

Advanced Clinical

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Trial Manager

  • Sep 2022 - Present

  As a member of the Client Pharmaceuticals Development Operations team, I manage external vendors and CROs, prepare study documents and manuals, coordinate and oversee the design of study materials such as CRFs, patient diaries, study participation cards and source documents, assist with protocol development and study report completion, manage monitoring activities at clinical study sites, provide guidance, direction, and management to CRAs, track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; assist in coordination of data management activities, coordinate study supplies, negotiate contracts with vendors of clinical trial services, review ICFs, CRFs, and study related materials, plan and participate in investigator meetings, assist and support data query processes, assure regulatory compliance of investigational sites with Client Pharmaceuticals’ SOPs and FDA and ICH guidelines, ensure that the TMF is current and sufficiently maintained, and assist with audits and inspection readiness. Show less



Organogenesis

• Biotechnology Research
• 700 & Above Employee

• Clinical Project Manager

  • Sep 2020 - Sep 2022

  As a Clinical Project Manager, I guided strategy, daily planning, and oversight of clinical trials for the Surgical & Sports Medicine (SSM) and Advanced Wound Care (AWC) portfolios.

• Clinical Research Associate II

  • May 2019 - Sep 2020

  As an in-house CRA, I was responsible for in-house monitoring of clinical studies to ensure compliance with protocols, SOPs, regulatory requirements, and ICH-GCP standards. I provided oversight of clinical monitoring activities and management of the eTMF, and was responsible for regulatory submissions and reports. Selected Achievements:• Coordinated study startup and monitoring throughout all phases, staying in communication with the CRO, investigators, and vendors to ensure compliance and consistency. • Maintained awareness of the clinical research landscape, including reviewing current literature and participating in networking events to ensure study alignment with industry changes and best practices. • Developed study plans and data reports, as well as managed the eTMF for up to seven trials simultaneously. Show less



University of Alabama at Birmingham

• Higher Education
• 700 & Above Employee

• Program Manager II, VA Medical Center Geriatric Research, Education & Clinical Center

  • Nov 2015 - May 2019

  Within the UAB Department of Medicine, I directed three large, simultaneous research projects for the Division of Geriatrics, Gerontology, and Palliative Care. Selected Achievements:• Spearheaded provider education and training efforts, including maintaining communication between all parties. • Led the audit process and monitoring of projects to ensure each project was aligned with stakeholder expectations. • Engaged with the clinical team, including RNs, CTCs, and CRCs, and delegated tasks based on project needs. Show less

• Data Analyst for the Jefferson County Family Court

  • Jul 2010 - Oct 2015

  I was responsible for data analysis and reporting for the partnership between the UAB Department of Psychiatry and the Jefferson County Family Court System. During this time, I participated in a comprehensive national initiative to reduce racial and SES disparities in juvenile justice programs.

• Substance Abuse Research Program Manager

  • Jan 2008 - Jul 2010

  , I managed two randomized clinical trials to assess medication-assisted therapies in the treatment of opiate dependency and other substance abuse issues within the criminal justice system

• Program Coordinator for the Shaken Baby Prevention Program

  • Aug 2006 - Dec 2007

  I began my UAB career in the Department of Medicine, where I oversaw program planning and reporting for the Division of Pediatrics’ Shaken Baby Syndrome Prevention program. In this role, I supervised and mentored five bilingual parent coaches and facilitated in-service trainings for parents and providers.