Clinical Operations Salt Lake
Resume:
Brenda J. Williams
Pronouns: She/Her
Curriculum Vitae
Email: ***********@*****.*** Mobile: +01-801-***-**** Professional Experience
Dates: January 2024 – February 2024
Company: Parexel, Inc.
Location: Salt Lake City, UT (remote position)
Title: Clinical Operations Leader*
*Terminated from position due to loss of studies/workforce reduction at assigned Sponsor (Moderna) Time Away from Work
Dates March 2023 – December 2023
Title: Caregiver
Job Responsibilities: Took care of aging parents. Sold house in SC, moved parents and pet across country (to CA), got them settled in retirement community (independent living community with levels of care), assisted with medical care. Professional Experience
Dates May 2021- February 2023
Company: Bill & Melinda Gates Medical Research Institute Location: Salt Lake City, UT, USA (Remote Position) Title: Clinical Trial Leader
Job Responsibilities: Provided sponsor oversight, quality project management, timelines and budgets for assigned Phase 1
& Phase 2b/2c clinical trials on Tuberculosis and infant RSV. Most clinical trials were conducted in Low Middle-Income Countries (e.g., South Africa, Philippines & Peru). Conducted vendor selection (i.e., CROs, Labs, Translation, Site recruitment, etc.), country and site feasibility for potential clinical trials. Activities included creating Request for Proposals, sending them to vendors and sites, obtaining feedback, holding bid defense meetings and budget review. Responsible for first contact with CROs and setting up parameters for site success. Collaborated with other functional groups at Gates MRI and represented the Clinical Operations Group by managing and leading global clinical trials. Also responsible for CRO/vendor management and monitoring oversight. Participated in SOP Committee and Process Improvement Projects such as TMF (Veeva Vault) and site start-up and closure processes. Dates May 2020 – May 2021
Company: GlaxoSmithKline (GSK) – Vaccines Division Location: Salt Lake City, UT, USA (Remote Position) Title: Senior Local Delivery Lead
Job Responsibilities: Mentored/coached new hires (i.e., new LDLs), became subject-matter expert and train the trainer on new TMF system (Veeva Vault Clinical), took on more leadership roles in team and lead feasibility exercises for new RSV vaccine program. Also, continued to perform clinical trial manager activities described in Local Delivery Lead position below.
Dates April 2014 – April 2020
Company: GlaxoSmithKline (GSK) / Novartis Vaccines, Inc (Novartis was acquired by GSK in 2015) Location: Salt Lake City, UT, USA (Remote Position) Title: Local Delivery Lead / Clinical Trial Manager Job Responsibilities: Provided sponsor oversight, quality project management, timelines and budgets for assigned Phase 1
– Phase IV clinical vaccine trials. Conducted country and site feasibility for potential clinical trials. Collaborated with other functional groups in Clinical Development and represent Region North America (US and Canada) Clinical Page 2 of 5
Operations Group. Mentored junior associates and acted as subject-matter expert for various systems. Also responsible for in-house study management and CRO/vendor management for large global pediatric influenza trial. Dates July 2012 – March 2014
Company: Novartis Vaccines and Diagnostics, Inc.
Location: Salt Lake City, UT, USA (Regional Position) Title: Associate Clinical Trial Manager
Job Responsibilities: Provided trial support to senior Clinical Trial Managers and ran in-house clinical trials. Also accountable for sponsor oversight, quality management, timelines and budgets of assigned clinical trials. Dates: June 2010 – June 2012
Company: Novartis Vaccines and Diagnostics, Inc
Location: Salt Lake City, UT, USA (Remote Position) Title: Senior Clinical Research Associate
Job Responsibilities: Oversaw ongoing clinical trials of investigational products (Phase I – Phase III) and ensured compliance with FDA regulations and GCP. Responsibilities included identification and qualification of sites, training of site personnel, establishing essential communication pathways with sites and project teams and assisting sites with recruitment, enrollment and retention. Also, performed monitoring activities as described in Watson Laboratories CRA position on page 2.
Dates: Sep 2007 – Mar 2010
Company: Wyeth, Inc. (Wyeth was acquired by Pfizer in Oct 2009) Location: Salt Lake City, UT, USA (Remote Position) Title: Senior Site Manager
Job Responsibilities: Oversaw ongoing clinical trials of investigational products (Phase I – Phase III) and ensured compliance with FDA regulations and GCP. Responsibilities included identification and qualification of sites, training of site personnel, establishing essential communication pathways with sites and project teams and assisting sites with recruitment, enrollment and retention. Also, performed monitoring activities as described in CRA on page 2. Other responsibilities included acting as the Lead Site Manager on several infant and adult vaccine studies. Dates: Feb 2007 – Sep 2007
Company: RPS, Inc., representing Wyeth Pharmaceuticals (MMAX Initiative, Team 1) Location: Salt Lake City, UT, USA (Regional Position) Title: Senior Regional Clinical Research Associate Responsibilities: Oversaw ongoing clinical trials of investigational products (Phase I – Phase III) and ensured compliance with FDA regulations and GCP. Responsibilities included identification and qualification of sites, training of site personnel, establishing essential communication pathways with sites and project teams and assisting sites with recruitment, enrollment and retention. Also, performed monitoring activities as described in CRA position on page 2. Dates: Jun 2006 – Jan 2007
Company: K-Force, Inc., on assignment for Pfizer Clinical Studies Location: Salt Lake City, UT, USA (Regional Position) Title: Senior Clinical Research Site Manager
Responsibilities: Oversaw ongoing clinical trials of investigational products (Phase I – Phase IV) and ensured compliance with FDA regulations and GCP. Responsibilities included identification and qualification of sites, training of site personnel, establishing essential communication pathways with sites and project teams, assisting sites with recruitment, enrollment and retention, and acting as the primary contact/site manager for all site questions and issues. Also, performed monitoring activities as described in CRA position on page 2. Dates: Jan 2005 – Jun 2006
Company: Watson Laboratories, Inc.
Title: Senior Clinical Research Associate
Location: Salt Lake City, UT, USA
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Responsibilities: Assisted with project management responsibilities for Phase I, Phase III, and Phase IV clinical trials. Responsibilities included serving as main contact for sites and monitoring team, tracking study activities across sites (e.g., enrollment, study supplies, SAEs, etc.), reviewing laboratory results to determine subject eligibility, communicating with vendors to resolve arising issues, and developing monitoring and tracking tools. Also assisted in the process of selecting sites to participate in new clinical trials and train/mentor junior Clinical Research Associates. In addition, continued to perform all duties listed below for CRA.
Dates: May 2003 – Dec 2004
Company: Watson Laboratories, Inc.
Title: Clinical Research Associate (CRA)
Location: Salt Lake City, UT, USA
Responsibilities: Oversaw ongoing clinical trials of investigational products (Phase I, Phase III, Phase IV) and ensured compliance with FDA regulations and ICH/GCP guidelines. Conducted monitoring visits and assisted with site management from site qualification to site termination (including query resolution). Prepared monitoring reports and provided sites with verbal and written feedback. Reviewed site regulatory documents for accuracy and completeness. Assisted with the development of protocols, informed consent forms, CRFs, source documents, training materials, and other monitoring tools.
Dates: Feb 2002 – Apr 2003
Company: Wasatch Clinical Research
Title: Study Coordinator II
Location: Salt Lake City, UT, USA
Responsibilities: Organized and implemented a large multicenter, double-blind, placebo-controlled Phase III Rotavirus vaccine clinical trial in healthy infants. Also trained new employees, collaborated with outside agencies, adhered to FDA regulations, maintained study documents, and reported to the IRB. Dates: Dec 2000 – Jan 2002
Institution: University of Utah, Department of Pediatrics Title: Study Coordinator for Neurobehavior Clinical Research Program Location: Salt Lake City, UT, USA
Responsibilities: Organized and managed all clinical research projects in our program. Studies focused on examining the developmental course of individuals with disabilities and the efficacy of treatment approaches implemented in our clinic. Other responsibilities included assisting PIs with project conceptualization and development by directing research methodology and design, grant writing and preparation, supervising research assistants, report writing, and preparing research proposals for IRB and Department of Human Service approval. Dates: Jan 1998 – Sep 2000
Institution: University of Utah, Department of Psychology Title: Independent Researcher (Masters’ Thesis)
Location: Salt Lake City, UT, USA
Responsibilities: Conceptualized, organized, collected, and analyzed data for a study examining the early development of autistic children who experience a regression.
Dates: Jun 1997 – Sep 1998
Institution: University of Utah, Department of Psychology Title: Research Fellow, Developmental Disorders Laboratory Location: Salt Lake City, UT, USA
Responsibilities: Organized and implemented a research project examining and differentiating specific executive functions in children diagnosed with various genetic and neurodevelopmental disorders (e.g., Autism, ADHD, Tourette’s Syndrome, FG Syndrome, NF1, and Joubert Syndrome). Supervised research assistants and assisted with data analyses. Dates: Jan 1996 – Mar 1999
Institution: University of Utah, Department of Neurology Title: Research Associate
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Location: Salt Lake City, UT, USA
Responsibilities: Assisted in data collection for a multicenter, double-blind, placebo-controlled drug study in patients with early onset Alzheimer’s Disease. Dates: Oct 1995 – May 1997
Institution: University of Utah, Department of Psychology Title: Research Assistant, Developmental Disorders Laboratory Location: Salt Lake City, UT, USA
Responsibilities: Assisted in data collection for a research project examining and differentiating specific executive functions in children diagnosed with Autism, ADHD, and Tourette’s Syndrome.
Dates: Nov 1994 – Aug 1996
Institution: University of Utah, Department of Psychology Title: Research Assistant and Laboratory Coordinator, Neuropsychology Laboratory Location: Salt Lake City, UT, USA
Responsibilities: Organized studies and assisted in data collection for a research project examining cognitive deficits found in patient groups with subcortical neuropathology
(e.g., Parkinson’s Disease, Huntington’s Disease, & Progressive Supranuclear Palsy). Dates: Feb 1993 – Aug 1994
Institution: MIT, Department of Biology
Title: Research Technician, Center for Cancer Research Location: Cambridge, MA, USA
Responsibilities: Assisted with the production and analysis of mutant mouse strains (called knock-outs) produced by gene targeting in embryonic stem cells. Genes that were made inactive were mainly involved with immune function.
Education
Institution: University of Utah
Location: Salt Lake City, UT, USA
Degree: Master of Science in Psychology
Major: Clinical Psychology; Areas of Concentration: Clinical Child & Family & Neuropsychology Awards/Achievements: Commendation for Teaching (Spring 2000) Institution: Saint Lawrence University
Location: Canton, NY, USA
Degree: Bachelor of Science
Double Major: Psychology & English Writing
Awards/Achievements: Graduated Cum Laude
Licenses/Accreditations
Dates: Sep 2005 – Dec 2009
Accrediation: Certified Clinical Research Associate (CCRA®) Publications
Filoteo, J.V., Williams, B.J., Rilling, L.M., & Roberts, J.W. (1997). Performance of Parkinson’s Disease patients on the Visual Search and Attention Test: Impairment in single-feature but not dual feature visual search. Archives of Clinical Neuropsychology, 12, 621–634.
Filoteo, J.V., Rilling, L.M., Cole, B., Williams, B.J., Davis, J., & Roberts, J.W. (1998). Variable memory profiles in Parkinson’s Disease. Journal of Clinical and Experimental Neuropsychology, 19, 878-888. Page 5 of 5
Krasny, L., Williams, B.J., Provencal, S., & Ozonoff, S. (2003). Social skills interventions for the autism spectrum: Essential ingredients and a model curriculum. Child and Adolescent Psychiatric Clinics of North America, 12
(1), 107-122.
Ozonoff, S., Williams, B.J., Gale, S., & Miller, J.N. (1999). Autism and autistic behavior in Joubert Syndrome. Journal of Child Neurology, 14, 636-641.
Ozonoff, S., Williams, B.J., Rauch, A.M., & Opitz, J.M. (2000). Behavior phenotype of FG Syndrome: Cognition, personality, and behavior in 11 affected boys. American Journal of Medical Genetics, 97, 112-118. Ozonoff, S, Williams, B.J., & Landa, R. (2005). Parental report of the early development of children with regressive autism: the delays-plus-regression phenotype. Autism, 9, 461-486. South, M., Williams, B.J., McMahon, W.M., Owley, T., Filipek, P.A., Shernoff, E., Corsello, C., Lainhart, J.E., Landa, R., & Ozonoff, S. (2002). Utility of the Gilliam Autism Rating Scales in research and clinical populations. Journal of Autism and Developmental Disorders, 32, 593-599. Therapeutic Area Experience
Neuropsychology (Neurology/CNS, Psychology)
- Alzheimer’s disease, Parkinson’s Disease, Supranuclear Palsy, Autism and other childhood neurological disorders such as ADHD, Down Syndrome, Tourette’s Syndrome) – experience was in academic and clinic settings
Pain (Fibromyalgia)
Pediatrics
-Probiotic study for underweight infants in LMIC
Infectious Diseases/Vaccines
- Tuberculosis
-Worked on Vaccines for Rotavirus, Pneumococcal Pneumonia, Meningitis, Influenza Malaria (worked with PATH)
Respiratory Syncytial Virus (RSV)
Dermatology
Nephrology
Tuberculosis
Urology
Oncology (Leukemia)
Language
Mother tongue: English, fluent in written & spoken proficiency
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