Baltimore, Maryland
Research Coordinator Job Opening in Baltimore, Maryland - Professional Performance Development Group (PPDG) is a government contractor who has been in the medical field providing medical services through our employees at major military medical centers for over 30 years.
We are an equal opportunity employer. Our employees represent the full spectrum of our society and are a testimony of our commitment to recognizing the dignity of the individual.
Scientific Research Support
Provide Support To:
C-STARS Baltimore, located at R Adams Cowley Shock Trauma Center, in the University of Maryland Medical Center, 22 South Greene St, Baltimore, MD
Full Time Position
In support of research at a 24-7 trauma center, work hours may require rotating shifts, weekends, and working after duty hours in support of specific tasking. Although schedule may have to be flexible, it will not exceed 40 hours per week per contract employee. Work hours are normally 5 days a week for 8 hours.
Travel:
Contractor will be required to travel when authorized to participate in USAFSAM, FH, and customer business line related meetings and conferences to fulfill respective mission goals. Such travel will only be as directed and coordinated through the COR two weeks in advance of all contractor travel in order to obtain proper authorizations.
Education
The minimum education required is a Bachelor?s of Science in a field of study related to Air Force expeditionary medicine or en-route care. A master?s degree is preferred.
Experience
Shall have extensive experience in institutional review board, program management, and directing research programs for the DoD.
Shall be former active duty military, with active duty experience in medical care, aeromedical evacuation and staging, military instruction, and medical simulation.
Shall have a regulatory research background with experience performing regulatory reviews.
Shall have scientific research experience, with knowledge of basic science research, consenting patients, data collection, data management, chart abstraction, and data analysis, and at least 2 years? experience and training in clinical and/or translational research including human subjects? protections, regulatory affairs, and data collection.
Shall have at least 10 years institutional review board.
The contractor shall perform the following specific tasks:
Coordinate military related research support. Coordinate and participate in all operational aspects of basic science, device, simulation, cadaver, and clinical research projects conducted by USAFSAM/FH, C-STARS Baltimore and University of Maryland.
Assess, prepare, complete, coordinate and submit protocol related documents to both local and military Institutional Review Boards (IRB) and Institutional Animal Care and Use Committee (IACUC). Assure compliance of general and study specific regulatory related processes with Standard Operating Procedures, as well as FDA, National Institutes of Health (NIH), and applicable regulations for the reporting of events to regulatory agencies. Prepare progress reports for the IRB/IACUC and provide auditing trails to assure protocol compliance. Maintain annual IRB approvals, amendments, and safety events, process data queries and ensure resolution. Identify problems and/or inconsistencies and monitor patients? progress to include documentation and reporting of adverse events; recommend corrective action as appropriate. Assist in preparation of amendments to protocols and/or modifications to study design as appropriate.
Screen patients for study enrollment, assist in obtaining informed consent, data collecting and maintaining databases. Participate in Rounds on trauma patients with the trauma team, and evaluate patients for study enrollment. Follow patients? progress in the study, collect data, and enter data into databases. Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Appraise and interpret collected clinical data in conjunction with principal investigators as appropriate; code, evaluate and interpret collected data and prepare appropriate documentation, obtain blood samples, cultures, tissues and other specimens for laboratory analysis. Confer with principal investigators to assist in developing plans for research projects, discuss the interpretation of results and collaborate on the preparation of manuscripts for publication.
Compile and track research budgets and expenses for government approval.
Review and extract data from existing military and civilian databases for research and quality improvement. Using Microsoft Office, assist with the development of Word documents, spreadsheets using Excel Program, presentations using PowerPoint and maintain local database using Access.
Assist and train faculty, residents, medical students, and cadets in basic and clinical science research. Provide guidance to lower level personnel involved in planning, implementation and evaluation of clinical studies. Assist in training new personnel. Maintain essential staff documents and coordinate human protections training for personnel.
Coordinate and schedule appointments with University of Maryland, Wright Patterson Air Force Base, and other organizations as needed. Coordinate animal ordering and delivery as needed. Oversee the ordering of supplies & equipment needed for research projects and keep track of pending orders.
Coordinate the development of data collection tools, questionnaires, databases and the application of research techniques. Assist in writing procedures manuals for data collection and coding. Review journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies. Design and accomplish reports, updates for government agencies quarterly, and upon request.
Be able to independently, or with minimal assistance, write or collaborate on writing Research Grants and supporting documentation in accordance with the provided in the solicitation. Prepare oral presentations or written reports and analyses setting forth progress, trends and appropriate recommendations or conclusions. Prepare briefing charts for USAFSAM/FH, 711 HPW Semi-Annual Reviews and Air Force Medical Modernization (AF/SGR) Program Management Reviews in accordance with specified format that captures the cost, schedule and performance status of each project. Draft and/or review written submissions for publication and or professional presentations.
Manage all aspects of a portfolio of wide ranging projects, tracking regulatory and reporting requirements, project successes, and study logistics.
Additional Information
Please call Andrea Bouchet-Botello at for more information.
Job Type: Full-time
Required education:
Bachelor's
Required experience:
human subjects and data collection: 2 years
institutional review board: 10 years
active duty or aeromedical evacuation: 1 year
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