Baltimore, Maryland
IRB RESEARCH SUPPORT ? RSI0172 Job Opening in Baltimore, Maryland - Regent Systems, Inc. (RSI) is currently bidding on a project and is seeking applicants for a qualified and experienced Institutional Review Boards Research Support Specialist, to support the research activities of the 711 Human Performance Wing (HPW) and C-STARS Baltimore. 24-7 trauma center, work hours may require rotating shifts, weekends, and working after duty hours in support of specific taskings. Although schedule may have to be flexible, it will not exceed 40 hours per week per contract employee.
Responsibilities
· Coordinate military related research support and participate in all operational aspects of basic science, device, simulation, cadaver, and clinical research projects.
· Assess, prepare, complete, coordinate, submit protocol related documents to both local and military Institutional Review Boards 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 compliance.
· Maintain IRB approvals, amendments, safety events, process data queries, 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 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 trauma team, and evaluate patients for 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/extract data from existing military/civilian databases for research, quality improvement.
· Assist with the development of Word documents, spreadsheets using Excel Program, presentations using PowerPoint and maintain local database using Access.
· Assist/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 documents and coordinate human protections training.
· Coordinate and schedule appointments with University of Maryland, WPAFB, and others.
· Coordinate animal ordering and delivery as needed.
· Oversee ordering of supplies/equipment needed for research projects. 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.
· 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.
Experience & Knowledge
· Scientific research experience, knowledge of basic science research, consenting patients, data collection, data management, chart abstraction, and data analysis.
· At least 2 years? experience and training in clinical and/or translational research including human subjects? protections, regulatory affairs, and data collection.
· Minimum 10 years institutional review board experience, program management, and directing research programs for the DoD.
· Former active duty military, with active duty experience in medical care, aeromedical evacuation and staging, military instruction, and medical simulation.
· Ability to work independently, have strong attention to detail, strong English skills, good organizational skills, initiative in performing assigned tasks and ability to follow-up complex projects.
· Ability to interact professionally with all levels of personnel in and outside of the organization.
Education and Certification
· 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.
The Company
Regent Systems, Inc. offers a full benefit package including company paid holidays, vacation, and personal time, medical, dental, vision, disability, life, flex spending, and 401k with company match.
Preference will be given to Veterans, Veteran spouses, and those with previous experience working for the military and/or government.
RSI is an Equal Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected Veteran status. In addition, RSI will not discharge, or in any manner discriminate against, any employee or applicant for employment because the employee or applicant inquired about, discussed, or disclosed the compensation of the employee or applicant or another employee or applicant.
Job Type: Full-time
Required education:
Bachelor's
Required experience:
clinical and/or translational research: 2 years
Required license or certification:
* Minimum Position of Trust / SF85
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