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Tyler Whitfield

About

Self-motivated clinical research (CCRC) and technology enthusiast (BS in software engineering) with 5+ years in site level research covering a wide range of responsibilities. High aptitude for problem-solving, identifying bottlenecks in complex systems, and acquisition and integration of new skills. Proven versatility to dynamic team structures and role variability.

Work Experience

CIRCA | PANDA Neurology | Atlanta Headache Specialists
Atlanta, GA
September 2021 – July 2022
Clinical Research Operations Manager
Highlights
  • Maintained the daily operations and project management of clinical research department for a pediatric & adult neurology practice
  • Accounted for all study startup activities including the execution of confidential disclosure agreement (CDA), clinical trial agreement (CTA), budget negotiations, pre-site selection visit (PSSV) & site initiation visit (SIV) scheduling, and continuing correspondence between involved parties
  • Executed all institutional review board (IRB) reporting for study startup, continuing reviews, safety, study closeout, and other required communication
  • Collaborated with CRO/Sponsor to ensure appropriate site and state specific requirements are implemented while editing informed consent and other patient facing documents
  • Served as main point of contact for PIs, coordinators, IRB, CRAs, CROs, and sponsors for all studies
  • Maintained site staff master file with protocol agnostic certifications for GCP, IATA, C-SSRS, CV, and medical licensing
  • Lead department meetings to ensure continued operational status during site search for operations director
  • Continued tasks of lead clinical research and data coordinator
CIRCA | PANDA Neurology | Atlanta Headache Specialists
Atlanta, GA
October 2018 – July 2022
Lead Clinical Research Coordinator
Highlights
  • Ensured strict adherence to FDA regulatory standards on up to 20 simultaneous neurology studies
  • Trained new staff on site SOP, created CAPA as required, and Served as mentor
  • Attended continuing education meetings on research methodology and neurology developments
  • Performed data management and statistical analysis on investigator-initiated studies and edited/co-authored final report
  • Continued tasks of clinical research and data coordinator
CIRCA | PANDA Neurology | Atlanta Headache Specialists
Atlanta, GA
October 2017 – October 2018
Clinical Research Coordinator
Highlights
  • Executed tasks as delegated by PI on various clinical trials in accordance with ICH/GCP guidelines
  • Served as primary contact with sponsors for designated studies
  • Ensured working knowledge and thorough understanding of clinical trial protocols, informed consent process, and laboratory and drug accountability requirements for all assigned studies
  • Facilitated Sponsor and/or CRO monitoring visits, including site initiation, interim, and close-out visits
  • Performed ECG/EKGs and sent to central or local cardiology facility for overread
  • Created original CRF source documents adherent to study-specific eCRF guidelines provided by Sponsor
  • Ensured timely data entry of source documents into eCRF and Ensured query resolutions of eCRF were reconciled with source documents
  • Conducted phase I-IV studies with pediatric, adolescent, and adult populations in a neurology clinic
  • Maintained integrity of trial master file through the duration of studies
  • Obtained subject vitals: height, weight, blood pressure (BP), respiratory rate (RR)
  • Accountable for all pharmacy duties not specifically delegated to PI
CIRCA | PANDA Neurology | Atlanta Headache Specialists
Atlanta, GA
March 2017 – October 2017
Recruitment Specialist
Highlights
  • Facilitated reduction in pre-screening redundancies and overlap by pushing the adoption of new recruitment system and training of site staff
  • Increased study enrollment by ~60% through rigorous pre-screening and re-organization of recruitment process

Projects

  • Lead Coordinator: Real-world Evidence of Duration of XXX for treatment of ADHD: An open-label pragmatic study to assess the real-world effectiveness of XXX in treatment of adult and adolescent patients with ADHD in the United States
  • Lead Coordinator: Evaluation of XXX ER 200 and 400 mg Efficacy and Safety in Children with ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial
  • Lead Coordinator: Evaluation of XXX ER 400 and 600 mg Efficacy and Safety in Adolescents with ADHD - A double-blind, placebo-controlled, pivotal trial
  • Lead Coordinator: Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of XXX for the Treatment of Pediatric Patients with Attention Deficit/Hyperactivity Disorder (ADHD)
  • Lead Coordinator: A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy and Safety of XXX Nasal Spray for the Treatment of Acute Migraine in Subjects Ages 6 to 11 Years, with an Open-Label Extension
  • Lead Coordinator: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of XXX Versus Placebo for the Preventive Treatment of Chronic Migraine in Pediatric Patients 6 to 17 Years of Age
  • Lead Coordinator: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of XXX Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age
  • Lead Coordinator: A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of XXX for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age
  • Lead Coordinator: An Observational Study to Investigate Cognition and Quality of Life in Children and Adolescents with Dravet Syndrome
  • Lead Coordinator: A single-arm, open label, multicenter study of the safety and efficacy of XXX for the acute treatment of migraine in adolescents
  • Lead Coordinator: preventive TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems
  • Lead Coordinator: Randomized, Double-Blind, Multi-Center, Parallel-Group Comparison of the Efficacy and Safety of the XXX (XXX Microneedle System) to Placebo for the Acute Treatment of Cluster Headaches
  • Lead Coordinator: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of XXX as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet Syndrome (DS)
  • Lead Coordinator: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of XXX as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS)
  • Lead Coordinator: A Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of XXX as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome
  • Coordinator: A Randomized, Double-Blind, Placebo-Controlled Study of XXX in Patients 6 to 17 Years of Age with Episodic Migraine
  • Coordinator: An Open-Label Trial to Assess the Safety of XXX (XXX) Oral Solution in Combination with Cannabidiol, as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome or Lennox-Gastaut Syndrome
  • Coordinator: An Open-Label Extension Trial to Assess the Long-Term Safety of XXX (XXX) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome
  • Coordinator: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral XXX for the Prevention of Migraine in Participants with Episodic Migraine
  • Coordinator: A Phase 3, Multicenter, Open-Label 40-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral XXX for the Prevention of Migraine in Participants with Episodic Migraine
  • Coordinator: A Randomized, Placebo-controlled Trial to Evaluate the Long-term (ie, Maintenance) Efficacy of Oral XXX in the Treatment of Pediatric Subjects with Tourette’s Disorder
  • Coordinator: An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of XXX in Pediatric, Adolescent and Adult Subjects with Epilepsy
  • Coordinator: Expanded Access Program for patients with Dravet syndrome who do not qualify for participation in one of the ongoing XXX (XXX) clinical trials
  • Coordinator: Prevalence of XXX Deficiency in Cerebral Palsy Patients with Unknown Etiology
  • Coordinator: Blood Collection Protocol for Clinical Laboratory Research Evaluating Biomarkers in Individuals with Dravet Syndrome
  • Coordinator, Videographer: A Randomized, Double-Blind, Placebo-Controlled Study of XXX for the Treatment of Dyskinesia in Cerebral Palsy in Children and Adolescents
  • Consultant, Data Manager: A Prospective, Open-Label Study of XXX for the Treatment of Chronic Migraine Headaches
  • Technical Liaison: A Phase 2, Open-label, Dose-finding Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Pharmaceutical Grade Synthetic XXX Oral Solution in Pediatric Patients with Treatment-Resistant Childhood Absence Seizures
  • Unblinded Pharmacist: A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XXX Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine.
  • Recruiter: A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of XXX Administered Intravenously in Patients with Chronic Migraine
  • Recruiter: An Open-Label, Multicenter Study with an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of XXX Oral Suspension when Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to less than 12 years) with Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic-Clonic Seizures

Contact

Atlanta, Georgia GA USA
LinkedIn

Education

  • 2020

    Kennesaw State University

    Bachelor of Science

    Software Engineering

  • 2014

    University of North Georgia

    Associate of Science

    Mathematics, Computer Science

Skills

Multidisplinary
Adaptive Problem Solving Attention to Detail Data Analysis Ethics Interdisciplinary/Systems Thinking Interpersonal & Team Skills Microsoft Office Suite - Excel, OneDrive, OneNote, Outlook, PowerPoint, SharePoint, Teams, Word Project Management Root Cause Analysis SQL & Database Design Technical Acumen
Clinical
ECG Electronic Health Records (EHR/EMR) ICH E6(R2) GCP Informed Consent Medical Terminology Regulatory Requirements Vitals
Electronic Data Capture - EDC/IxRS/RTMS/CTMS
Almac Calyx/ClinPhone ClearClinica ClinCapture Clinical 6/Clinical Ink ClinicalStudio/TrialKit drugDevSpark eCaselink endpoint ePIP Clario/ERT Firecrest IBMClinical medidata Oracle InForm Parexel SecureConsent SharePoint StudyTeam Thread Veeva YPrime