Summary
Overview
Work History
Education
Skills
Studies
Timeline
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Bibi Broome

Georgetown,KY

Summary

Clinical Research Program Manager with six years of research experience at the University of Kentucky. Experience across multiple departments at UK Healthcare. Adept at tracking results, implementing data collection procedures and auditing project data to ensure timely delivery of accurate results. Well versed in driving participant care quality and optimizing workflow processes to efficiently utilize resources. Result driven, research inspired, and passionate.

Overview

15
15
years of professional experience

Work History

Research Program Manager

University Of Kentucky, Neuroscience
01.2023 - Current
  • Providing the fundamentals of research coordination training & laboratory/benchtop skills to neurology residents, medical students, NeuroBank employees, visiting research scholars, undergrads/graduate students, and various others at PI's request.
  • Collaborating with PIs/departments/institutions for procuring biospecimens to fulfill research needs of supported studies.
  • Phlebotomy trained personally aiding in extended collaborations with various clinical research departments across UK that require this service.
  • Establishing relationships while maintaining communications that foster/facilitate collaborations with a large network of PIs/UK Healthcare & campus staff/various departments both within/outside of the University of Kentucky.
  • Maintaining regular updates on 16 supported studies with PIs/staff.
  • Creation of tailored and evolving reports based on PI criteria. Providing documentation for/maintaining adherence to IRB policies.
  • Streamlining operations and creating individualized documentation each study from collection to sample processing protocols and data management.
  • Leading screening/hiring process while working with ever changing student schedules to guarantee daily coverage of NeuroBank and it's supported studies.
  • Keeping staff apprised of study schedules/assignments for consistent coverage of all studies through implementing effective communication SOPs with research coordinators, nurses, and physicians.
  • Onboarding of all staff both directly and tangentially to ensure full training and appropriate access to online/software systems necessary for coordinators (UK Healthcare WBTs, CITI, REDCap, OnCore, Environmental Health & Safety, IATA training, research certifications, Operating Room training, etc.)
  • Monitor expiration of staff certificates (GCP, CRC, HSP, EHS, IATA, etc.) and laboratory certificates to ensure compliance to all research/UK regulations.
  • Fill in gaps for multitudes of roles when necessity arises.

Research Coordinator

University Of Kentucky, College Of Public Health
07.2021 - 01.2023
  • Coordinated protocol development, advertisement materials, equipment preparation, financial reconciliations/payments, and materials purchasing for planned studies as sole research coordinator.
  • Prepared documents, reports, and presentations detailing results and conclusions, educated potential donors on studies and metrics, collaborated with BPTP for specimen processing & storage.
  • High recruiting numbers from Turfland Family Medicine (500 subjects in less than one year)/Bluegrass Care Clinic (100 subjects in six weeks)
  • Set up new wet lab for PI.

Clinical Research Associate I

University Of Kentucky, CCTS
09.2017 - 07.2021
  • Plan, organize, implement & manage clinical research studies from pre-study to study close out; screening, recruitment, consenting, source document & SOP creation, eCRFs & date entry, monitoring lab work, testing scores, AEs, medication dispensing/shipping/reconciliations, administering cognitive testing, training subjects on device usage, assessing protocol resources/finances, training staff and patients on use of injectables.
  • Managed over 100 research subjects across seven studies.
  • Aided coordinators with clinical aspects of their studies (phlebotomy, vitals, cognitive testing, processing, etc.)
  • FDA Drug Approval for Palynziq® after three years of meticulous site coordination.

Clinical Services Tech II

University Of Kentucky, Dept. Of Gyn/Oncology
06.2014 - 09.2017
  • Coordinated annual Markey Cancer Center Wreath Auction (marketing, wreath collecting, cataloging, photographing, drafting item descriptions, announcing & informing winners, arranging for payment & wreath pick-up).
  • Registering patients, collecting vitals, obtaining medication/health histories, prepping patients for exam room procedures, phlebotomy, securing patient prior authorizations, aiding in all aspects of EPIC transition.
  • Aided Dr. Frederick Ueland, MD with specimen collection and data entry for his oncology trials.

Practice Manager & Personal Assistant

Stephen C. Josephson, PhD
10.2012 - 03.2014
  • Managed daily operations for bustling boutique psychology practice with over 100 patients, all VIPs/celebrities, to ensure proper appointment scheduling, patient records management, billing/insurance functions.
  • Accounts Payable for personal/business accounts and coordinating all international travel with multi-city stops, office move/renovations/repairs, etc.

Office Manager

BrainPOP
09.2008 - 01.2011
  • Created, maintained and updated filing systems for paper and electronic documents while updating reports, managing accounts, and generating reports for quarterly financial reports.
  • Oversaw office inventory activities, coordinated multi-city logistics for educational conferences
  • Heavy travel scheduling internationally and event coordinating for various high end business functions.

Education

Master of Arts - Psychology

The New School For Social Research
New York, NY
05.2009

Bachelor of Arts - Psychology

State University of New York, Albany
Albany, NY
05.2002

Skills

  • Project Management & Team Leadership
  • Regulatory & Protocol Compliance
  • Clinical Trial Operations
  • Budget Management
  • Communication & Collaboration
  • Problem-Solving
  • Data Management, Analysis & Quality Assurance
  • Adaptability & Learning Motivated
  • Clinical Skills & Phlebotomy

Studies

College of Public Health

  • Discovery, Discovering Novel Predictors of Oropharyngeal Cancer Recurrence in Kentucky
  • ORACLE, Oral HPV Prevalence Among People Living with HIV: A Pilot Study
  • Voyager, HPV16 E6 Antibody Detection as an Early Marker of Oropharyngeal Cancer


Center for Clinical and Translational Science 

  • PKUDOS, PKU Demographics, Outcomes, and Safety Registry
  • Biomarin 165-302, A Four-Part, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Discontinuation Study to Evaluate the Efficacy and Safety of Subcutaneous Injections of BMN 165 Self Administered by Adults with Phenylketonuria
  • BioMarin 307-902, A Prospective Clinical Study of Phenylketonuria (PKU)
  • SHP 634-404: An Open-Label, Randomized, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Profiles of Once-Daily and Twice-Daily Dose Regimens of recombinant human Parathyroid Hormone (rhPTH[1-84]) Administered Subcutaneously to Subjects with Hypoparathyroidism
  • Synuclein Seeding, Synuclein Seeding Activity in Parkinson’s Disease Patients undergoing Deep Brain Stimulation
  • REPRIEVE, Randomized Trial to Prevent vascular Events in HIV
  • Segerstrom, Thoughts, Stress & Immunity


NeuroBank

  • Parkinson's Biomarkers, Biofluid-Based Markers for Differentiating Parkinson's Disease Phenotypes
  • Neuroscience Biobank, NeuroBank
  • Degenerative Cervical Myelopathy Repository, Development of a predictive outcome model for patients with degenerative cervical myelopathy using objective functional and biological measures
  • SCING, An Open-Label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of Oral Glyburide (DiaBeta) in Patients with Acute Traumatic Spinal Cord Injury
  • A-Syn in REM Sleep Disorders, Predicting development of neurodegenerative disorders through saliva biomarkers in patients with REM sleep behavior disorder
  • Inflammation & SCI, Pro-Inflammatory and Lipid Biomarkers after Spinal Cord Injury
  • PLSNH, Primary Lateral Sclerosis (PLS) Natural History Study
  • Banking Neurologic Diseases, Banking Patient Samples for the Study of Neurologic Diseases




Timeline

Research Program Manager

University Of Kentucky, Neuroscience
01.2023 - Current

Research Coordinator

University Of Kentucky, College Of Public Health
07.2021 - 01.2023

Clinical Research Associate I

University Of Kentucky, CCTS
09.2017 - 07.2021

Clinical Services Tech II

University Of Kentucky, Dept. Of Gyn/Oncology
06.2014 - 09.2017

Practice Manager & Personal Assistant

Stephen C. Josephson, PhD
10.2012 - 03.2014

Office Manager

BrainPOP
09.2008 - 01.2011

Master of Arts - Psychology

The New School For Social Research

Bachelor of Arts - Psychology

State University of New York, Albany
Bibi Broome