Ernestine Copeland, CEO

Biography  

Ernestine Copeland, BA, AA, MA, CRP

 

I have gained experience as an Expert Clinical Research/Regulatory Associate, (CRA/RA) with 20+ years of proven research, demonstrating unparalleled knowledge of clinical practices, design controls, harmonized standards, and ICH guidelines. Mastery in clinical trial methodologies, clinical trial management systems, to include CTMS, eTMF, ADP, Medical Manager, IDX, EPIC, Oracle, and Regulatory Start-Up. Extensive knowledge in GCP and ICH guidelines, FDA regulations, CRA tasks and roles, medical terminology, medical assisting, working with various Phases, I-IV Clinical Studies with reputable health organizations, such as Johns Hopkins Hospital/University, (b) Duke University, (c) University of Maryland, (d) and Greater Baltimore Medical Systems.
 

I have earned an Associate of Arts in Business Administration and a Baccalaureate Degree in Business with a concentration in Management from Strayer University. I am also experienced with Regulatory Compliance Management duties including: Analyzing internal business systems to ensure compliance with industry regulations and ethical standards, Creating modifying, updating and implementing the company’s policies, developing risk management strategies, designing control systems to address cases of violation of internal business policies, designing ongoing training programs for employees of the business, liaising with internal and external departmental leads to ensuring business operations are in line with business policies, advising top management on business operations and strategic planning relating to investments, risks, and various research developments. 

 

Regina Brock Simmons, COO

Biography  

Regina Brock Simmons, MSN, BS, RN, CCRP, 

 

I come before you with over twenty years of a DIVERSE background in biological laboratories, academic and private clinical research entities, research, and infusion nurse. While working on my bachelor's degree in biology, minor in Chemistry, I worked full-time in the chemistry laboratory and later in a biological laboratory where I was able to grasp an understanding of chemicals and process the various components of blood products. 

 

Shortly afterwards, I started my journey as a Research coordinator and shortly promoted as an assistant supervisor where I was able to build and develop my supervisory skills by providing training, support and oversight of other research coordinators and research assistants. During this time, I was completing my degree in a full-time status. Once the grant ended, I accepted a position as a Clinical Research Manager/Supervisor. As a Clinical Research Manager/Supervisor, I was able to work on a major project alongside the lead site to bring the site into compliance with the requirements as the site was running without structure and organization to required documentation. When that project ended, I accepted a position as a Senior Clinical Research Coordinator. As a Senior Clinical Research Coordinator, I worked with multiple Principal Investigators on various projects where I was able to assist with publications, train nurses how to perform research, and return to school full-time to obtain an Associate’s of Science in Nursing. After passing the nursing board exam, I was promoted to a Research/Infusion Nurse where I was able to build upon my nursing experience. 

 

In 2015, I interviewed for the CRA position as I am deeply passionate about research and helping others. As a Clinical Research Associate, I proactively trained and mentored novice and newly protocol assigned CRAs. Throughout building the CRA experience, I performed PSVs, SIVs, monitoring activities, COVs and OCEs. 

 

3 Key Points to my Background: 

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I. Strong managerial, clinical research and healthcare background, and in-depth knowledge of various therapeutic indications and thermodynamics of drugs from experience as a Project Coordinator/Supervisor, Research/Infusion Nurse, and CRA.

 

lI. Initiative: Willing to learn about new areas of the healthcare industry. Transitioned seamlessly and excelled from academic entity research to nursing, and now to organizational clinical research. Ability to quickly learn responsibility of each role, the computer tools and systems utilized, completion of training courses, and willingness to assist others. 

 

III. Team Player: Always a ‘Can-Do’ Attitude as noted in my evaluations in each position. In areas where a team is lacking or weak, I can quickly identify and implement strategies and/or organize the team to work as a strong unit to address deficiency. Try to lead teams to greatness. Many Awards for Team Player and Collaboration. 

 

Communication Skills: Demonstrated ability to successfully interact with all levels of mgt and outside agencies. Research Coordinator/Nurse: Families, patients, physicians, phlebotomists, scheduling coordinators, nurses, medical staff, IT, IRB, CROs, sponsors, auditors, and other vendors CRA: CTMs, COMs, PMs, Physicians, nurses, coordinators, pharmacist, and sponsors.