Odyssey Systems has an exciting new opportunity for a Clinical Research Coordinator supporting the Clinical Investigation Program at the 99th Medical Group. The primary mission of the regional CIP at the 99th Medical Group (MDG) is to support Graduate Medical Education research at the 99 MDG, 96th MDG, 375 MDG and any other collaborating research locations including the VA Southern Nevada Healthcare System. In conjunction with the Nellis Family Medicine Residency, CIP researchers constantly pursue the advancement of military healthcare, utilizing cutting-edge strategies and methods. As part of the Regional CIP, Nellis CIP researchers also assist Eglin, Scott and any other bases participating under the Regional CIP program with many of the regulatory duties and processes related to their research programs, including assistance with renewing/updating their DoD Assurance, Institutional Review Board (IRB) submissions and guidance, regulatory folder set up, direction on recruitment, consenting, and data collection.

***Contingent upon contract award***

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  Provide administrative support to include the collection, compilation, and documentation of research data, in accordance with the details outlined in the research protocol for a given study and in according with HIPAA guidelines.
• Assist Principal Investigator in identifying recommended protocol changes as needed.
• 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.
• Maintain integrity of data within data collection tools, spreadsheets and databases. Monitors and evaluates procedure data. May develop system for Quality Assurance/Quality Control (QA/QC) checks; performs QA/QC checks.
• Assist in ensuring quality of project deliverables to include providing study-specific information and patient success stories.
• Assist with formal audits and coordinate with study auditors, regulatory agencies, collaborators, and sponsors in management of research studies.
• Monitor research subjects’ progress to include documentation and reporting of adverse events to the Medical Monitor or Data Safety and Monitoring Board, sponsor, and the Institutional Review Board. Recommend corrective action as appropriate.
• Identify delays and other shortcomings in meeting objectives and study recruitment goals, develop a contingency plan as needed.
• 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.

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  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.

• Experience assisting with acupuncture research preferred.
• Experience working within the Military Medical system (e.g., as military, civilian employee or government contractor) preferred.