Summary
Overview
Work History
Education
Skills
Certification
Clinical Trials
Timeline
Generic

Lelia T. Halloran

Amelia,VA

Summary

Detail oriented, organized central monitor with 11 years’ cumulative experience looking to further my career in clinical research.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Central Monitor

Syneos Health (inVentiv) - GSK Pharmaceuticals
03.2021 - 07.2024
  • Inspect near-real-time aggregate clinical and operational data from multiple sources (eCRF, vendor data, digital health/wearables, etc.). Utilize data analytics and visualizations to uncover insights and see complex patterns within data.
  • Use Key Risk Indicators (KRIs) to identify significant issues and emerging risks at the study site, program, country.
  • Clearly document the detected issue / emerging risk.
  • Translate the issue / emerging risk—the situation, the significance / implication of the data insight, and what further action is required—breaking down complex concepts into simple language.
  • Communicate findings as per planned process to ensure that all cross-functional stakeholders have the same understanding of the issue / emerging risk so that the appropriate follow-up action can be taken.
  • Arm the primary site monitor with important information that will enable Sponsor to be the clinical partner of choice; allowing monitors to work differently with site staff and have more productive discussions with our Investigator partners.
  • Work collaboratively in the pursuit of quality with the primary site monitor, the Study Team and cross-functional departments.

Billing Specialist

Counseling Horizons
07.2019 - 05.2022
  • Manage all client accounts
  • Enter charges for therapy sessions, administrative work, and legal charges
  • Submit insurance claims and follow up for payment
  • Allocate payments received, both self-pay and insurance
  • Communicate with clients regarding outstanding charges, answer any billing questions, and provide clarification on any billing items.

Clinical Research Coordinator

Neurological Associates
07.2018 - 03.2021
  • Coordinate research-related activities with clinical and non-clinical staff throughout the health system
  • Provide supervision and direction to clinical trials under the direction of the Principal Investigator
  • Manages clinical trial subject visits, perform tasks delegated by the Principal Investigator, and conducts the informed consent process
  • Coordinates and manages clinical studies according to OHRP and FDA regulations, as well as, ICH Good Clinical Practices and IRB requirements
  • Assists in preparing study contracts and budgets
  • Obtain detailed knowledge of all components of study protocol through independent analysis and review of study to complete all study activities completely.

Clinical Research Associate

American Research Associates, llc
10.2017 - 07.2018
  • Responsible for the management and coordination of clinical research studies conducted by Medacta USA in Richmond, VA and Newport News, VA
  • Responsible for monitoring data at sites across the United States for accuracy, completeness, and identify any issues with the data collection
  • Assist in the building, production, and maintenance of a study’s EDC system with IBM.

Research Coordinator & Patient Educator

OrthoVirginia
01.2013 - 10.2017
  • Coordinates and manages clinical studies according to OHRP and FDA regulations, as well as, ICH Good Clinical Practices and IRB requirements
  • Educating patient’s on surgical procedures and the post-operative courses
  • Working in the clinical setting as well as answering all telephone calls
  • Staff training, development, and ongoing evaluation of assigned clinical sites.

Patient Care Technician

Bons Secours St. Francis Medical Center
06.2011 - 10.2013
  • Assist patients with activities of daily living
  • Take vital signs, ambulate patients, check blood glucose levels
  • Assist the nursing staff with various tasks.

Education

Master of Public Health -

Liberty University
12.2015

BS in Health Sciences -

James Madison University
12.2012

Skills

  • Clinical research trial start-up
  • ICH/GCP
  • AE and SAE reporting
  • Efficient in various EDC systems
  • Detail oriented
  • Excellent communication skills
  • Patient recruitment
  • Budget negotiation
  • Patient retention
  • Informed consent process and documentation
  • Clinical research monitoring
  • Data entry
  • Risk assessment
  • IRB submissions
  • Data evaluation
  • Detailed documentation
  • Patient safety
  • Site management
  • Clinical study reports

Certification

  • 10/2018, Certified Clinical Research Coordinator, ACRP
  • 09/2018, Basic Life Support (CPR and AED) Program, American Heart Association

Clinical Trials

  • Novocart 3D Autologous Chondrocyte Implant System, Aesculap Biologics, LLC, (2015-2017), Prospective, randomized, controlled, multicenter, phase-III clinical study evaluating the safety and effectiveness of Novocart 3D compared to the standard procedure microfracture for treatment of articular cartilage defects in the knee.
  • NUsurface Meniscus Implant, Active Implants, LLC, (2015 - 2017), Randomized, multicenter, prospective, interventional clinical trial evaluating the effectiveness of the NUsurface device compared to standard of care treatments.
  • An Investigation of ReNu Knee Injection, NuTech Medical, (2015 - 2017), Prospective, randomized study evaluating the efficacy of ReNu in patients with Kellfren-Lawrence grade II-III osteoarthritis.
  • PROGRESS IV Clinical Trial, Zimmer Biomet, (2017), Double-blind, multicenter, randomized, controlled trial for patients with early to moderate symptomatic knee osteoarthritis in one knee who failed previous conservative therapy.
  • Single-use Efficiency Instruments With Patient Specific Technique (MyKnee) Versus Traditional Metal Instruments With Conventional Surgical Technique, Medacta USA, (2017 - 2018), Multi-center, Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed With Single-use Efficiency Instruments With Patient Specific Technique (MyKnee) Versus Traditional Metal Instruments With Conventional Surgical Technique.
  • Alkermes ALK8700-A302, Alkermes, (2018 - 2019), A Phase 3 Study in Subjects with Relapsing Remitting Multiple Sclerosis to Evaluate the Tolerability of ALKS 8700 and Dimethyl Fumarate
  • Alkermes ALK8700-A301, Alkermes, (2018 - 2021), A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis
  • RESTORE, Lundbeck NA Ltd., (2018 - 2021), A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion to assess Sustained effecTs Of dRoxidopa therapy
  • INSYTE ACP-103-037, ACADIA Pharmaceuticals, (2018 - 2021), Prospective, observational study evaluating the management of Parkinson’s Disease Psychosis in Actual Practice (The INSYTE Study).
  • A0081096, Pfizer Inc., (2018 - 2020), Prospective Randomized 12-Week Controlled Study of Visual Field Change in Subjects with Partial Seizures Receiving Pregabalin or Placebo (Pro00026427).
  • MASTER-2, EMD Serono, (2019 - 2021), Observational evaluation of effectiveness and patient-reported outcomes (PROs) in suboptiMAlly controlled patientS previously Taking oral or infusion disEase-modifying dRugs (DMDs) for relapsing forms of multiple sclerosis (RMS) (MASTER-2).
  • CLICK-MS, EMD Serono, (2019 - 2021), Observational evaluation of effectIveness and patient-reported outcomes (PROs) in suboptimally Controlled patients previously taKing injectable disease-modifying drugs (DMDs) for relapsing forms of Multiple Sclerosis (RMS) (CLICK-MS).
  • DUET (EP0092), UCB Biopharm SRL, (2019 - 2020), A multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Padsevonil as adjunctive treatment of focal-onset seizures in adult subjects with drug-resistant epilepsy.
  • EP0093, UCB Biopharm SRL, (2019 - 2020), An open-label, multi-center, extension study to evaluate the safety and efficacy of Padsevonil as adjunctive treatment of focal-onset seizures in adult subjects with drug-resistant epilepsy.
  • ACP-103-063, ACADIA Pharmaceuticals, (2020 - 2021), A 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson’s Disease Psychosis.
  • AbbVie M15-736, AbbVie, (2020 - 2021), Advanced Parkinson's Disease: Double-Blind, Double-Dummy, Active-Controlled, Efficacy and Safety Study of ABBV-951 Versus Oral Carbidopa/Levodopa.
  • TemPo2, Cerevel Therapuetics, LLC, (2020 - 2021), A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson’s Disease (TemPo-2 Trial).
  • AbbVie M20-098, AbbVie, (2020 - 2021), An Open-Label Extension of Study M15-736 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects with Advanced Parkinson’s Disease.
  • TemPo3, Cerevel Therapuetics, (2020 - 2021), A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TemPo-3 Trial).
  • 324-ETD-201, SAGE Therapuetics, Inc., (2020 - 2021), A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Efficacy, Safety, and Tolerability of SAGE-324 in the Treatment of Individuals with Essential Tremor.
  • GEMINI2, Genzyme Corporation, (2020 - 2021), A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio) in participants with relapsing forms of multiple sclerosis (GEMINI 2).
  • TemPo4, Cerevel Therapuetics, (2021), 58-Week Open-Label Trial of Tavapadon in Parkinson’s Disease (TemPo-4 Trial)
  • SUVN-G3031, Suven Life Sciences Limited, (2021 - 2022), A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in Patients With Narcolepsy With and Without Cataplexy
  • TrilynX, EMD Serono Research & Development Institute, Inc., (2021 - 2023), A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)
  • PROGRESS, Incyte Corporation, (2023 - 2024), A Phase 2, Randomized, Double-Blind, Placebo-Controlled STudy to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants with Fibrodysplasia Ossificans Progressiva (PROGRESS)
  • IMG-7289/MK-3543, Imago BioScienes, Inc., (2023 - 2024), A Multi-Center, Open Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Patients with Myeloproliferative Neoplasms (MPNs) Enrolled in a Prior Bomedemstat Clinical Study
  • 405-201-00016, Otsuka Pharmaceutical Development & Commercialization, Inc., (2023), A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Efficacy and Safety of Once Daily Centanafadine Capsules for the Treatment of Adolescents With Attention-deficit/Hyperactivity Disorder
  • 405-201-00017, Otsuka Pharmaceutical Development & Commercialization, Inc., (2023 - 2024), A Phase 3, Multimeter, Open-label, Long-term Trial Evaluating the Long-term Safety and Tolerability of Once Daily Centanafadine Capsules in Children and Adolescents With Attention-deficit/Hyperactivity Disorder (ADHD)
  • CTP2S1911A4B2, Suven Life Sciences Limited, (2024), A Phase 2a Open-Label Study Evaluating the Safety and Efficacy of Ropanicant in Participants With Moderate to Severe Major Depressive Disorder

Timeline

Central Monitor

Syneos Health (inVentiv) - GSK Pharmaceuticals
03.2021 - 07.2024

Billing Specialist

Counseling Horizons
07.2019 - 05.2022

Clinical Research Coordinator

Neurological Associates
07.2018 - 03.2021

Clinical Research Associate

American Research Associates, llc
10.2017 - 07.2018

Research Coordinator & Patient Educator

OrthoVirginia
01.2013 - 10.2017

Patient Care Technician

Bons Secours St. Francis Medical Center
06.2011 - 10.2013

Master of Public Health -

Liberty University

BS in Health Sciences -

James Madison University
Lelia T. Halloran