Novell McGloster, MS.ED, CRA

Sr. Clinical Research Associate

Employment

July 2019- Present
Micron Medical Corporation
606 Banyan Trail; Boca Raton, FL 33034

Clinical Research Monitoring Manager (Full Time):

Micron Medical Corporation has the first FDA cleared system for Spinal Cord and Peripheral Nerve stimulation, pending approval for overactive bladder. The Protect PNS provides a non-surgical therapy option for chronic pain. This system utilizes the world’s smallest, wireless, microsize neurostimulator and leverages patented advancements in microtechnology.

  • Site monitoring management including oversight of site initiation visit, Clinical Site and Micron personnel training and documentation, 17 locations (with travel)
  • Oversee clinical site management especially regarding administration, clinical support, study plan meetings, data output and reports for study/data metrics, compliance, and maintain excellent partnerships with site PIs and staff to maximize clinical outcomes.
  • Ensure assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Institutional Review Boards (IRB), and Good Clinical Practices (GCP) guidelines; Ensuring all regulatory requirements are appropriate methods, practices, procedures, and protocols for all research activities in noted area; Interim and annual reporting
  • FDA annual reporting; IDE, 510K and De Novo adverse event reporting summaries and submissions.
  • Develop clinical research protocols for pilot and pivotal device trials
  • Draft, edit and review Clinical Trial Agreements; Created clinical trial sites contact and training information tracking systems; Develop site recruitment methods
  • Risk based monitoring through multiple electronic data capture systems (EDC) and extraction analysis
  • Development of data-management plans, data-entry and data handling guidelines/SOPs, and other study support documentation; while tracking all clinical activities to ensure proper documentation is in place
  • Created financial tracking system for clinical research, including budget preparation, invoicing, and reconciliation
  • MasterControl collaborations.
  • Participate in regulatory strategy and interfaces with key functional groups; Creating and directing program/project-related advisory committees as needed, DSMB and/or expert consultants.
  • Statistical analysis of clinical data, utilizing algorithms and/or real-world evidence to prove clinical outcomes, writing summary reports and technical articles and publications, quarterly Shareholders and PROTECT RCT Newsletters
  • Establish and maintain mutually beneficial relationships with contractors, shareholders, and investors

September 2016- May 2018
Laszlo J. Mate, M.D., P.A.
824 US Highway #1, Suite #230; North Palm Beach, FL 33408

Clinical Trials Manager (Full Time to Part Time):

Dr. Mate is one of the leading adult and pediatric Neurologists in South Florida. He is recognized for his over 25 years of Alzheimer’s, ADHD, Epilepsy and Multiple Sclerosis research.

  • Supervised Neuroscience clinical trials in compliance with all applicable regulatory requirements
  • Budget preparation, invoicing, and reconciliation; Facilitated payments
  • Created study documents such as: Regulatory and Reference binders, Case Report Forms (CRF), Enrollment and Drug accountability logs; Staff training
  • Develop recruitment methods using third party clinical trial recruitment agencies, Facebook, medical records, local print, and digital media
  • Phlebotomy and vital signs
  • Laboratory Management; Interactive Voice/Web Response System (IVWRS) Investigational Product (IP) storage and site supply management
  • Risk based monitoring and reporting instances of noncompliance; EDC query resolution; Coordinated and facilitated monitoring visits; Study close-out procedures and follow up

June 2011- September 2015
Children’s Healthcare of Atlanta (CHOA) – Scottish Rite
CHOA/Ponce de Leon Center/Emory Children’s Center (ECC)
1001 Johnson Ferry Road, Northeast; Atlanta, GA 30342/341 Ponce De Leon Avenue Northeast;
Atlanta, GA 30308

Senior Clinical Research Coordinator (PRN to Full Time):

CHOA is one of the leading pediatric hospitals in the country, recognized for excellence in cancer, cardiac, neonatal, orthopedic, and intensive care. The Ponce De Leon Center is one of the largest, most comprehensive facilities dedicated to the treatment of advanced HIV/AIDS in the US.

  • Supervised Neuroscience, HIV and Oncology clinical trials in compliance with all applicable regulatory requirements
  • Created study documents such as: Regulatory binders, ICFs, CRFs and Enrollment logs
  • Developed recruitment methods such as: Clinic medical records screenings, hospital print and digital media; Scheduled subjects and facilitated the informed consent process
  • Phlebotomy and vital signs
  • IVRS/IWRS IP and site supply management; Study close-out procedures and follow-up
  • Risk based monitoring and reporting instances of noncompliance; EDC query resolution; Coordinated and facilitated monitoring visits; Study close-out procedures and follow up

May 2011-August 2012
National Center for Primary Care (NCPC)
Morehouse School of Medicine
720 Westview Drive, SW; Atlanta, GA 30310- 1495

Research Administrator III (Full Time):

NCPC is an academic research, training, and resource center focused on promoting excellence in community oriented primary care and optimal health outcomes for all Americans.

  • Provided guidance on sponsored project administration
  • Conducted pre- award activities related to procuring funding and other extramural awards; Assisted with post- awards processing and vendor payments; and Collaborated with PIs, managers, and other departments to prepare budgets
  • Monitored awards and reported progress of funding activities to funding agencies
  • Maintained training and compliance documents for study staff (ex. FDA Forms 1572, CVs, etc.)

December 2009- April 2011
Research Mississippi, Incorporated (RMI)
GV (Sonny) Montgomery Veterans Administration Medical Center (VAMC)
1500 East Woodrow Wilson Drive; Jackson, MS 39216

Institutional Review Board (IRB) Administrator (Full Time):

Research, Mississippi! Inc. (RMS) is a VA affiliated Non-Profit Corporation (NPC) and exists to provide the G. V. (Sonny) Montgomery VA Medical Center with a flexible funding mechanism to support research activities.

  • Principal advisor over program operations servicing the following Veterans Administration Medical Centers: Biloxi, MS; Jackson, MS; Fayetteville, AR; Mobile, AL; New Orleans, LA; Panama City and Pensacola, FL
  • Screened research and ensured appropriate review according to federal regulations
  • Monitored meeting minutes, board contingencies, tracked adverse events and protocol deviations
  • Conducted special projects to analyze, evaluate and provide recommendations on administrative issues

February 2008- February 2009
Worldwide Clinical Trials Drug Development Solutions Clinical Research Services (WCT)
2455 NE Loop 410 # 150; San Antonio, TX 78217-6707

Clinical Research Coordinator (Full Time):

Worldwide is the first customer centric CRO. Founded by physicians dedicated to advancing medical science, WCT strategically balances science, medicine, operations, and commercial intelligence to achieve successful drug development.

  • Mass IP dosing with 24-hr timeline follow-up
  • Monitored and reported instances of noncompliance; EDC query resolution; Facilitated monitoring visits
  • Developed and maintained mutually beneficial professional relationships with sponsor and vendor representatives

June 2003- January 2008
Mississippi State Department of Health (MDH)
Crossroads Clinics- Sexually Transmitted Infections and Infectious Diseases Specialty Clinic
570 East Woodrow Wilson Drive; Jackson, MS 39216

Senior Clinical Research Coordinator (Full Time):

A doctor referral program and clinic of MDH specializing in sexually transmitted diseases prevention and care.

  • Supervised Infectious Diseases medical device trials in compliance with all applicable regulatory requirements
  • Budget preparation, invoicing, and reconciliation; Facilitated payments
  • Created study documents such as: Regulatory binders, ICFs, CRFs, Enrollment and Device accountability logs; Site supply management
  • Developed recruitment methods such as: Clinic medical records screenings, hospital print and
    digital media; Facilitated the informed consent process
  • Phlebotomy and vital signs
  • Maintained training and compliance documents for study staff; Assisted in the development and editing of manuscripts; Monitored and reported instances of noncompliance
  • Developed and maintained mutually beneficial professional relationships with sponsor and community representatives

Education

  • Jackson State University – Jackson, MS
    Degree: Master of Science in Education
    Major: Health Education GPA: 3.93 (Summa cum Laude)
    1400 John R. Lynch Street.
  • Jackson State University
    Degree: Bachelor of Science
    Major: Mass Communications Concentration: Public Relations
    Minor: Business Marketing GPA: 3.88 (Magna cum Laude)

Research Trainings

Collaborative Institutional Training Initiative (CITI) – December 2019, November 2017, October 2016, January 2013, May 2011, June 2010, June 2009, May 2007, May 2006, May 2005, August 2004, and August 2003.

Publications

Burton, M. J., Sunesara, I., Penman, A., Pham, H., Oliver, N., Young, C. A., McGloster, N., et al. (2011). Comparing the aspartate aminotransferase (AST) to platelet ratio index (APRI) between African American and White veterans with chronic hepatitis C. The Southern medical journal, 104(5), 309-314.

Volunteering

August 2015- Present
Rowdy dot Biz
www.Rowdy.biz
1353 Holly Heights Drive #2, Fort Lauderdale, Florida, United States 33304

Recreation Therapist:

  • Utilizing recreation, leisure, and other interest activities as interventions to address the assessed and diagnosed needs of individuals with illnesses and/or disabling conditions, as means to psychological and physical health, recovery and well- being.

Awards and Honors

  • Minority Graduate Tuition Scholarship- August 2010, August 2011
  • Alpha Epsilon Lambda National Honor Society- March 2011
  • Phi Kappa Phi National Honor Society- January 2004
  • Macy’s Minorities in Medicine- January 2000

References

  • Leandro Mena, MD, Infectious Diseases- Principal Investigator, University of MS Medical Center
  • Allison Davis, RN, Registered Nurse/current law student- Mercer University, Private Care
  • Miriam Isma, Manager, Clinical Affairs, Micron Medical Corporation
  • Alvin Watson, Owner, Kids R Chefs