Clinical Research Program Manager

Employer
Vesa Health & Technology, Inc
Location
Baltimore, MD
Posted
Jun 13, 2017
Closes
Jun 21, 2017
Industry
Research
Hours
Full Time
Vesa Health & Technology is seeking a qualified Research Program Manager to support The Center for the Sustainment of Trauma and Readiness Skills (C-STARS), Baltimore. This is an Air Force Medical Service training platform partnered with the University of Maryland, Baltimore Shock and Trauma Center that provides advanced training and research opportunities for Department of Defense (DoD) medicsThe Research Program Manager shall provide research guidance services, clinical research coordination, and assistance in areas required to meet the stated objectives and to accomplish the work required. The contractor assistance shall be for use by the C-STARS Baltimore, Maryland Operating Location (OL), sister C-STARS sites, and the United States Air Force School of Aerospace Medicine Department of Aeromedical Research (USAFSAM/FH).The contractor shall perform the following specific tasks and have demonstrated previous experience indoing so: support the research activities of the 711 Human Performance Wing (HPW) and CSTARS Baltimore during the conduct of basic science, simulation, device, cadaver, and clinical research projects directly supporting DoD, Air Force, 711 HPW, USAFSAM/FH and C-STARS Baltimore. 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, CSTARS 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. Be able to independently, or with minimal assistance, write or collaborate on writing Research Grants and supporting documentation in accordance with the guidance/instructions provided in the solicitation. Prepare oral presentations or written reports and analyses setting forth progress, trends and appropriate recommendations or conclusions. Manage all aspects of a portfolio of wide ranging projects, tracking regulatory and reporting requirements, project successes, and study logistics.Qualifications: MUST BE PMI (PMP) and DoD certified project/program manager with experience directing research programs for the DoD. Have former active duty military experience. The contractor additionally, shall have a scientific research background with knowledge of basic science research, data management, principles of epidemiology, statistics, and the scientific method and at least 10 years' experience and training in clinical and/or translational research including human subjects' protections, regulatory affairs, and data collection. Shall have direct experience in clinical research, grant writing, laboratory research, and in writing Institutional Animal Care and Use Committee (IACUC) proposals. A track record of peer reviewed publications and presentations is required (minimum of 10). Experience in device development,technology validation and maturation, and military research is required.The minimum education: PhD in a biological science (not including social sciences) or field of study related to Air Force expeditionary medicine or en-route care trauma research; additionally an MBA is highly desired.