Experience

Emerson Clinical Research Institute

• United States
• Research Services
• 1 - 100 Employee

• CEO & Research Director

  • Mar 2013 - Present

  Emerson Clinical Research Institute's focus is to work with its partner clinics in the Washington D.C metropolitan area. Our goal is to provide under represented patients with the opportunities to participate in high quality clinical research protocol. Our mission is to take studies out to the community, for those patients witch don't have the means to visit major medical centers. Emerson Clinical Research Institute's focus is to work with its partner clinics in the Washington D.C metropolitan area. Our goal is to provide under represented patients with the opportunities to participate in high quality clinical research protocol. Our mission is to take studies out to the community, for those patients witch don't have the means to visit major medical centers.



Inova Health System

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Pediatric Research Director

  • Jun 2012 - Mar 2014

  •Supervise research program’s staff in caring out complex research actives producing research deliverables. •Establish priorities and assign outcomes deliverables to research personnel. •Manage performance and implement action plans to meet research program objectives. •Manage the financial and academic portfolio of over 150 studies. •Maintain effective research program compliance with all applicable regulations. •Identify and support the development of new clinical research protocols. •Development and update of departmental business plan. •Manage and grow the departments’ research portfolio, negotiate research opportunities for industry sponsored protocols. •Represent pediatric research in hospital leadership meetings. •Provide mentorship and guidance to residents and staff physicians on the development and successful execution of investigator initiated and sponsored studies. •Chair the Pediatric Research Council in the development of new studies. Show less



United States Department of Defense

• United States
• Armed Forces
• 700 & Above Employee

• Supervisory Research Integrity & Compliance Officer (GS-14)

  • Dec 2008 - Jun 2012

  •Work closely with and provide subject matter expertise to site commanders, investigators, senior officials, and other senior personnel to assess the need of the institution. •Conduct high level briefings to Army General Officers •Write in-depth reports of site visit to include: the review of the HRPP Management Plan; SOP’s for IRB meeting, scientific review, Institutional Biosafety Committee; IRB membership qualifications, IRB study records, investigator study records, subject study files, and product accountability. •Work closely with Directors of the U.S. Army Medical Research and Material Command Office of Research Protections and the Clinical Investigations Regulatory Office to ensure harmonization collaborative projects end events. Also, work with the MRMC subordinate research laboratory U.S. Army Medical Research Institute of Infectious Diseases, and Walter Reed Army Institute of Research. •Represent the Army or AHRPO during planning meetings of the regional medical commands assured institutions and medical treatment facilities. •Represent AHRPO during planning meetings and discussions of current activities of the Joint Combat Casualty Research Team. Work directly with the directors and team members actively in theater of war operations. •Member of the Headquarters review committee for the Infectious Disease Clinical Research Protocols based at the Uniformed Services University of the Health Sciences. I review IRB determinations and assure DoD service–specific requirements are met. Protocols reviewed are based in the United States and internationally. •Serve as the main point of contact for for all research related activities requiring headquarters support:Dental Command, Show less



Marymount University

• United States
• Higher Education
• 700 & Above Employee

• Adjunct Professor

  • Sep 2007 - Dec 2008

  •Main instructor in the Anatomy and Physiology laboratory section. •Led lively course discussion explaining the structures and functions of the systems in the human body. •Developed exams, quizzes and practical evaluations, keeping diligent record of the same. •Tutored and mentored students. •Main instructor in the Anatomy and Physiology laboratory section. •Led lively course discussion explaining the structures and functions of the systems in the human body. •Developed exams, quizzes and practical evaluations, keeping diligent record of the same. •Tutored and mentored students.



MedStar Research Institute, Washington Hospital Center

• Regulatory Manager- Office of Research Integrity

  • Aug 2006 - Dec 2008

  Institutional Biosafety Committee (IBC); Re-established the IBC to ensure recognition and approval from NIH/OBA to comply with NIH Guidelines for recombinant DNA research. Led development of institutional SOP’s, guidelines and policies. Streamlined the application process to the IBC with the development of a new application form and review process, recruited and selected qualified IBC members. Performed independent protocol audits and made recommendation of all studies requiring IBC oversight. Educated institution on the need and purpose of the IBC by writing articles for the internal news letter, and leading presentations to research staff.• Conflict of Interest (COI): Assisted in the development and review of policies and procedures, reviewed protocols with potential conflict of interest, presented cases to the COI committee, recommended management strategies to protocol investigators.• FDA MedWach: Monitored the FDA safety information adverse event reporting, Identified studies that fell under the particular alert, communicated with research staff and advised on best management approach for Good Clinical Practice, tracking and monitoring of a safe management plan to ensure subject safety.• Developed new reporting documentation and policy of Unanticipated Problems for human subject protection program.• Institutional Review Board (IRB): Headquarters’ administrator for all activities pertinent to the clinical studies for the National Institute on Aging (NIA), and three additional MedStar Health hospitals in the Baltimore area.• Scientific Review Board (SRB): Focused on studies which were investigator initiated, and required peer review, as well as review of studies which the IRB deemed to lack a scientific basis or benefit. Conducted initial scientific review to protocols, made recommendations to the Chair, and assigned appropriate committee reviewer. Worked with investigators to develop scientifically appropriate studies. Show less

• Program Manager – Phase II Clinical trial (Levetiracetam to Prevent Post-Traumatic Epilepsy)

  • Aug 2006 - Dec 2008

  •Head of all clinical trial operations, and all administrative activities, oversight of federally funded (NIH/NINDS) adult and pediatric acute head injury study at multiple sites. Ensured trial operations were in compliance with Good Clinical Practice and Food & Drug Administration (FDA) regulations, Investigational Review Board (IRB) regulations.•Conducted comprehensive physical and neurological exam of adult and pediatric patients enrolled into the study. Coordinated multiphase follow-up visits and specimen collection at WHC and Children National Medical Center clinical research center. Educated, recruited, and determined patient eligibility and compliancy.•Participated in on call rotation for patient evaluation, enrollment, and medication administration, as well as required phlebotomy.•Assisted with the creation and modification of electronic case report form system, audits of charts and records.•Submitted documentation to the FDA for Investigational New Drug (IND).•Developed study of SOP’s.•Was the Liaison between principal investigator and personnel at NIH, WHC and Children National Medical Center.•Translated patient informed consent and education material from English to Spanish•Managed and tracked status of 1.8 million dollar government study budget. Assisted the Office of Contracts and Grants Management with the development of study-related budgets modifications and supplements. Budgeted patient financial compensation, research pharmacy and hospital laboratory payments.•Key role in the submission of a 1.5 million dollar Department of Defense (DOD) Grant for a Congressionally Directed Medical Research program. Reviewed supporting documentation, guided multiple national and international sites in the development of budgets, and impact statement. Show less



Sanford Brown College

• Hospitals and Health Care
• 100 - 200 Employee

• Adjunct Professor

  • Oct 2004 - Dec 2006

  •Developed and instructed the courses for Medical Assisting Program students in Medical Terminology, Clinical Procedures, Pharmacology, and Anatomy and Physiology. •Explained the economics of Medicare and Medicaid public policy and how the Medicare and Medicaid systems affect overall medical practice. •Tutored and mentored students. •Developed and instructed the courses for Medical Assisting Program students in Medical Terminology, Clinical Procedures, Pharmacology, and Anatomy and Physiology. •Explained the economics of Medicare and Medicaid public policy and how the Medicare and Medicaid systems affect overall medical practice. •Tutored and mentored students.



Lockheed Martin

• United States
• Defense and Space Manufacturing
• 700 & Above Employee

• Director of On-site Operations – Phase II Clinical Study for the NIH Clinical Center

  • Dec 2004 - Apr 2006

  •Developed project design and integration for pilot testing of a government awarded contract on a biometric patient identification system. Implemented biometric system involving patient enrollment into a database via fingerprinting, facial recognition, and iris scanning. The system evaluated the effectiveness, acceptance, and feasibility of biometrics as a means of recognition to verify patient identification. •Created bilingual patient education programs including brochures, presentation, and demonstrations to convey how emerging technologies can effectively be used in a clinical setting. •Management responsibilities included recruitment, training, and mentoring of on-site staff. Managed staff at the NIH Clinical Center Hematology Oncology Day Center. Provided support and problem resolution for novel biometric enrollment station. •Acted as liaison between head quarters and NIH clinical director, hospital staff members and international scientists. •Presented the biometric system, its functions, benefits and results to groups interested in learning more about the clinical study. •Evaluated results of the pilot project and reported findings to the NIH Clinical Center directors. Show less