Odyssey Systems has an exciting new opportunity for a Research Administrative Assistant supporting the Clinical Investigation Program at the 99th Medical Group at Nellis AFB, Nevada.

• Provide assistance to faculty, residents, students, and other staff members to provide administrative support for clinical research operations. The Clinical Research Assistant shall assist with coordinating department operations in support of approved protocols and applicable Air Force, DoD, and Federal regulations while promoting the safety and confidentiality of research subjects and their data at all times. Assist Principal Investigator in identifying recommended protocol changes as needed.
• Coordinate administrative and Institutional Review Board approval of proposed research protocols, protocol amendments, progress reports, and final reports and maintain regulatory binders.
• Ensure appropriate maintenance and renewal of human subject research protection training and other research required trainings for each individual listed on research protocol and maintain current curriculum vitae or resumes in accordance with individual Institutional Review Board policies.
• Ensure annual human subject research protection training and maintain current certificates in accordance with individual Institutional Review Board policies.
• Ensure conflict of interest forms are received and maintained in accordance with individual Institutional Review Board policies.
• Advertise for the assigned studies utilizing the approved recruitment materials. Draft new recruitment materials and identify new avenues for recruitment as needed.
• Provide support to plan and organize technical and consultative meetings.
• Liaise regularly with the Clinical Investigations Program to keep abreast of current clinical research protocols and regulations; attend their department meetings as appropriate.
• Meet with potential research subjects; explain the research project in detail, independently judge suitability of research participants, review subject inclusion/exclusion criteria, and recruit eligible subjects into the study by obtaining written informed consent and HIPAA Authorization, ensure Principal Investigator signs inclusion/exclusion prior to entering research subject into the study.
• Serve as point of contact for research subjects; schedule research visits, clinic room time and other services where needed.
• Obtain research data through interviews with research subjects, administer and scores questionnaires, extract information from paper or electronic records in accordance with approved research protocols, maintain study codes, organize research data for analysis by a statistician.
• Assist with formal audits and coordinate with study auditors, regulatory agencies, collaborators, and sponsors in management of research studies.
• Receive and report adverse events, protocol deviations, and other reportable actions to the Medical Monitor or Data Safety and Monitoring Board, sponsor, and the Institutional Review Board.
• Ensure compliance of general and study specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance with the details outlined in: research protocols, applicable Standard Operating Procedures, Food and Drug Administration regulations, Air Force Instructions, Defense Health Agency (DHA) directives, DoD Directives, MDG Instructions, Department of Veterans Affairs regulations, Institutional Review Board (IRB) specific regulations, Office for Human Subject Research Protections, The Declaration of Helsinki, The Belmont Report, National Institutes of Health (NIH) guidance and Good Clinical Practices.
• Perform light duties and other related duties as required and assigned.
• Assists CIP Director in various tasks.
• Maintain a safe workplace; observes appropriate safety and occupational health rules and regulations.
• Employee is required to attend safety and other training relative to his/her position and report infractions of safety procedures to the facility Safety Officer.
• Must obtain and maintain CITI training and annual Human Subject Research Protection training in accordance with IRB policy.

• Must have current Human Subject Research Protection training Office of the Under Secretary of Defense “Personnel and Readiness”.
• Must have current Basic Life Support (BLS)
• Must be detail oriented and able to work independently following a brief period of specific technical training.
• Available to travel in order to provide services, receive specialized training, and/or coordinate between research sites when it’s in the best interest of the Government.