Cayuse Native Hawaiian Veterans (CNHV) provides innovative and flexible solutions to federal government clients, emphasizing excellence in the Asia-Pacific region. CNHV's capabilities, market-relevant service offerings, past performance credentials, and diverse status allow government clients to engage quickly and confidently with CNHV. Core service areas for CNHV include Health & Medical Services, Unexploded Ordnance (UXO), Surface & Underwater Range Clearance, Explosive Ordnance Disposal (EOD), Executive Briefing Teams, Training, Exercise Support, Computer Facilities, and Emergency Management Services.

SUMMARY:

The Clinical Research Associate II shall create Standard Operating Procedures (SOPs) for and maintain oversight and
responsibility for all study data collection processes as outlined in IRB approved protocols, including archiving and
file management. Complete initial set up and close-out of study/studies files and databases, collection
and data entry, and ongoing organization and maintenance of all research study/studies records and data in a
computerized format.

The Clinical Research Associate II shall assist the principle investigators with assorted administrative tasks as needed. Some
flexibility may be needed to respond quickly to unanticipated mission requirements and accurately collect and file
data.

The Clinical Research Associate II shall be responsible for all study approval submissions and processes. Adhere to legal,
professional and ethical codes with respect to confidentiality and privacy. Responsible for explaining research
protocols and obtaining signed consent from patients and research trial candidates as required per protocol and
ensure compliance with subject consenting and reporting of adverse events and side effects.

The Clinical Research Associate II shall assist investigators as needed with construction and maintenance of study databases
and study data collection forms, and data entry tasks. Build data files and manage data entry of all data, maintaining
an updated and organized literature library, on-going communication with the research team(s) to maximize study
objectives as well as the collection of data at required study points per study protocol(s).

The Clinical Research Associate II shall provide regulatory compliance support to include preparation of IRB amendments,
annual report, etc. and assist with preparing sponsor technical reports and/or site Command reports. They will also
be responsible for maintaining study files in accordance with the standards of Good Conduct of Research

RESPONSIBILITIES:

• Track expenditures for all study-related activities, including supplies and equipment.
• Provide inputs to final reports that document the research findings for human useprotocols including, but not limited to those listed above.
• Assist with the development of new studies, to include assist with writing,packaging, and submitting of research study proposals. Assist with identifying new funding sources andcollaborators.
• Assist the Strategic Outreach Service in meeting coordination between Madiganresearch investigators and extramural collaborators interested in performing quality improvement/quality assurance(QI/QA) and clinical research.
• Emailing involved parties, agenda creation, escorting of visiting parties, and follow-up coordination
• Reports to: The Government's Representative
• Other duties as assigned

MINIMUM QUALIFICATIONS:

• Bachelor's Degree

• 3 to 5 years' experience working in a clinical research environment.

• General and medical experience, involving clerical, office, or other work that indicates ability to acquire the particular knowledge and
  skills needed to perform the duties of the position

• Possess sufficient initiative, interpersonal relationship skills and social sensitivity such that he/she can relate constructively to a variety of patients from diverse backgrounds.
• Have the required education, training, experience and documented current competence in the required specialty position description

WORKING CONDITIONS:

• TBA

Cayuse and our family of companies are 100% Indian Small Business Economic Enterprises (ISBEE) wholly owned by the Confederated Tribes of the Umatilla Indian Reservation (CTUIR). Specifically, within our Government Operations, we offer diverse business lines and workforce while providing solutions for federal, state, and local clients throughout the world. Cayuse's comprehensive program management, mission support, and technology solutions are ideally positioned to help our clients advance their goals.