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LEADERSHIP

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Meet our CEO and founder

CAPT Kwatemaa, RN, MSN

CAPT Kwatemaa, RN, MSN, CCRP is a retired United States Public Health Service (USPHS) officer with 30 years of service. During her career as an active duty officer, she worked with many accomplished research scientists and investigators in various HHS facilities, including NIH, HRSA, FDA, and CDC.   She held several positions in various Institutes within National Institutes of Health (NIH), including 5 years as a Critical Care Nurse in the Clinical Center Nursing Department; 5 years developing and managing the Procedures, Vascular Access, Conscious sedation (PVC) Service for Critical Care Medicine Department.

More About CAPT Kwatemaa

Over the last 20 years, she held a leadership position, directing the clinical research support services provided to various Laboratories within National Institute of Allergy and Infectious Diseases (NIAID).  CAPT Kwatemaa possesses a Master degree in Clinical Trials from Drexel University and has been recognized for her career notable accomplishments and leadership role at the NIH.  She is the recipient of several NIH Director awards, multiple USPHS distinguished and commendation medals, and Meritorious award from the Department of Navy. As a subject matter expert in the conduct of clinical research, her expertise and management style have resulted in the generation of multiple high profile projects in the area of gene therapy, gene deletion, and bone marrow transplantation research studies for rare inherited immunodeficiency disorders. She is nationally certified by SoCRA and is a member of the Regulatory Affairs Professional (RAP) Organization.  She co-authored multiple clinical research protocols and publications. 

 

Together with our expert team, we understand the challenges involved in clinical studies and will be available to support your project team as needed. Our experienced team will provide more efficient program execution, including the ability to predict and overcome complex study issues in an expeditious manner and complete your project within the required timeline.

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PAST Performance/Experiences:

  • Established NIAID Research Support Team, providing research study  development, implementation, and management of high-profile projects in the  area of gene therapy and bone marrow transplantation for rare inherited  immunodeficiency disorders

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  •  Directed healthcare members in the execution of trials and resolution of logistical constraints and assures all aspects of Good Clinical Practice (GCP) and federal regulatory requirements are met/exceeded.

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  • Directed and performed quality assurance and quality control activities as they relate to a protocol adherence, protocol monitoring, data collection data abstraction, and data analysis and assures standard operating procedures reflect the highest standards of data integrity and patient safety.

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  • Oversight management of trial treatment,  devices, natural history studies within NIAID and pharmaceutical companies. 

  • Development and management of electronic regulatory document management systems, compliant with FDA and HHS regulations. 

  • Development of an innovative clinical research management infrastructure  focusing on patient safety and research protocol integrity. 

  • Development of regulatory and study implementation Standard of Practice  (SOP), proficiency tools, and data collection tools in order to enhance  productivity and adherence to the regulatory requirement for each research  project.

  • Conduct staff training and education on all matters related to research

  • Authored multiple research protocols in areas of novel clinical research projects

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