Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
Generic

Kirk Booker, MPH, CCRP

Houston,TX

Summary

Experienced, versatile, and diligent healthcare professional with a Master's degree in Public Health and 10+ years of experience in Clinical Research and Healthcare. I am driven by a passion to lead and develop innovative ways to improve the quality of research and health services while maintaining a patient-centered care approach.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Senior Coordinator, Clinical Research Program

MD Anderson Cancer Center, MMO
01.2025 - Current
  • Served as primary point of contact during regulatory audits and monitoring visits, ensuring audit-readiness and compliance with regulatory expectations.
  • Organized and lead meetings to support the PI and study operations.
  • Produced tracking documents to assist in organization and completion of essential regulatory documents.
  • Responsible for managing relationships with sponsors and regulatory agencies to facilitate study startup, maintenance, and closure.
  • Conducted ongoing reviews of departmental regulatory systems to assess feasibility.
  • Implemented regulatory management techniques to overcome obstacles and increase team productivity.
  • Developed internal requirements and standards to minimize regulatory risks and liability.
  • Provide regulatory expertise and training to department staff, ensuring adherence to Good Clinical Practice (GCP), CFR, and ICH guidelines.
  • All duties of a Clinical Research Program Coordinator.

Clinical Research Program Coordinator

MD Anderson Cancer Center, Gyn Onc & Rep Med
07.2019 - 12.2024
  • Provides regulatory and administrative support for program activities and projects for the department’s Clinical Research Program
  • Schedule and lead departmental research program meetings to assist in providing oversight and support for all designated site specific research programs including Developmental Therapeutics, Cancer Prevention, Health Services Research, and Innovative Surgery
  • Responsible for the implementation, management, and continuity of multiple multicenter/international clinical trials, Sponsored, and IIT trials
  • Schedule and prepare relevant materials for Site Initiation Visits (SIV) and Activation Planning meetings
  • Coordinates and leads collaborative meetings and other communications with the PI, and clinical trial sponsors to evaluate and audit existing studies and to make recommendations for process improvement
  • Responsible for preparing research studies for submissions, amendments, monitoring and annual reviews according to institutional guidelines using ePRTCL, Oncore, OneIRB, Advarra eReg, Prometheus, REDCap, and other applicable software
  • Coordinates and completes pending regulatory action items for monitoring visits with sponsor pharmaceutical companies and clinical research organizations
  • Responsible for the utilization of technical writing ability to compose and abstract medical and scientific information for preparation of written correspondence, reports, and protocols under the direction of study investigators
  • Responsible for the development of study amendments, informed consents, and all other required supporting documentation
  • Interfaces with the Office of Human Subjects Protections and external regulatory committees and offices. Interacts with protocol sponsors (industry, NCI, and cooperative group)
  • Serves as departmental resource regarding protocol submission process, formatting requirements, staff training, deadlines, and regulatory issues and process for submission of sponsored IND trials.
  • Trains and oversees new regulatory staff on multicenter trial activation and processes
  • Submits SAE reports to PI and IRB when necessary
  • Responsible for ensuring that all regulatory and institutional requirements are met before study activation.
  • Revises protocols as directed or required and composes the correspondence accompanying the revisions
  • Maintains regulatory binder for all assigned studies
  • Interacts and provides appropriate correspondence to industry trial monitors, IND office monitors, and institutional auditors
  • Serves as study monitor for external sites collaborating on GYN trials Submits and tracks research agreements (study contracts, material transfer agreements, and confidentiality disclosure agreements) until they are fully executed through the legal department
  • Ensures all participating sites are in compliance with the protocol and office of protocol research
  • Responsible for maintaining and preparing regulatory documents for audits. Manages and maintains external site regulator files

Project Coordinator

Menninger Clinic
01.2015 - 07.2019
  • Coordination and management of Research Projects and Clinical Trials
  • Clinical trial planning, implementation, and evaluation from initiation to completion
  • Administered Transcranial Direct Current Stimulation (tDCS) to subjects - Phase 2
  • Responsible for the operation, sanitation, and storage of all medical devices used in the clinical trial
  • Detailed knowledge of medical terminology from coursework and collaboration with Physicians, Internists, and Pharmacists
  • Intermediate knowledge in operating neurotargeting software
  • IRB revision and submission
  • Assisted with the construction and administration of psychometrically validated measures
  • Perform all direct care duties and support associated with inpatient clinical trial
  • Collaborate with multiple disciplines to provide and receive patient updates and reports (Nursing, PT, Pharmacy, Rehabilitation, Social Work, and Psychiatry)
  • Genetic sample collection and storage
  • Responsible for patient recruitment and informed consent
  • Data collection, entry, & management of all patient information, case reports, and adverse event reports in the Qualtrics software system
  • Collaboration with unit staff and treatment team to ensure regulatory compliance and patient safety
  • Schedule patient clinical trial appointments and transportation to the proper facility

Research Assistant

Menninger Clinic
09.2013 - 01.2015
  • Perform initial clinical outcomes assessment and analysis to begin research process
  • Administer clinical outcomes assessments to patients through electronic devices and structured interview
  • Track clinical progression data of patients from admission to discharge
  • Collaborate with treatment team to plan patient and program goals
  • Consent patients to follow up study-Track patient progression
  • High completion rate on follow up study - 100+ Subjects
  • Write and submit research papers for publication
  • Data collection, entry, & management
  • Assisted with the development of a new outcomes battery with psychometrically validated measures
  • Health Information Management System (HIMS) Committee Member
  • Program Management internship
  • Developed new process for employee evaluation which resulted in marked performance improvements
  • Worked directly with program Medical Director and Nurse Manager to achieve an increase in positive employee engagement ratings and patient satisfaction - 35% increase in one quarter

Behavior Therapist

Texas Young Autism Project
06.2012 - 08.2013
  • Applied Behavior Analysis (ABA) therapy for children and adolescents with autism and other learning disabilities
  • Therapy with clients in clinical setting and community based (in-home)
  • Case manager/Lead Therapist for multiple clients
  • Detailed session reports and documentation
  • Data collection and entry
  • Improve client functioning in deficient social, learning, and behavioral areas
  • Monthly review of client progress, behavior, and goals

Education

Master's Degree - Public Health Policy & Management (MPH)

University of North Texas Health Science Center
Fort Worth, TX
05.2017

Bachelor's Degree - Psychology

Stephen F. Austin State University
Nacogdoches, TX
05.2012

Skills

  • Clinical Trial Management
  • Cultural Competent Care
  • Effective written communication
  • Organization & Time management
  • Ability to handle large quantities of projects
  • Microsoft Windows
  • Database Management
  • Public Speaking
  • Data Collection
  • Health Services Management
  • Patient Focused Care
  • Program Planning, Implementation, and Evaluation
  • Staff and Patient Scheduling and Organization
  • Direct Patient Care

Accomplishments

Certifications:

Certified Clinical Research Professional (CCRP)

- Society of Clinical Research Associates

Certified in Public Health

- National Board of Public Health Examiners CITI Biomedical Research

CITI Good Clinical Practice

Completed all LEADing Self Core courses categorized by the LEADing self-characteristics: Social Intelligence, Drive, Professionalism, Emotional Intelligence, Coachability.

Certification

  • Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates
  • Certified in Public Health - National Board of Public Health Examiners
  • CITI Biomedical Research
  • CITI Good Clinical Practice

Timeline

Senior Coordinator, Clinical Research Program

MD Anderson Cancer Center, MMO
01.2025 - Current

Clinical Research Program Coordinator

MD Anderson Cancer Center, Gyn Onc & Rep Med
07.2019 - 12.2024

Project Coordinator

Menninger Clinic
01.2015 - 07.2019

Research Assistant

Menninger Clinic
09.2013 - 01.2015

Behavior Therapist

Texas Young Autism Project
06.2012 - 08.2013

Bachelor's Degree - Psychology

Stephen F. Austin State University

Master's Degree - Public Health Policy & Management (MPH)

University of North Texas Health Science Center

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