Overview

Cayuse Government Services, LLC (CGS) is committed to excellence by providing innovative and flexible solutions to State, Local and Tribal government clients. CGS also provides mission critical technology delivery as a shared service in our Oregon Technology Delivery Center, which also provides support to CGS’ Federal Government clients.

The Clinical Research Associate II shall work in a clinical research environment within the Department of Clinical Investigation. They may interact with multiple medical disciplines such as General Surgery, Pediatrics, and/or Orthopedics. They will be responsible for assisting with the development of new studies, including assistance with writing, packaging, and submitting research study proposals. Provide coordination of investigators with study site personnel such as logistics/supply resource management, contracting, and DCI assets such as Data scientists and animal Veterinarians. Assist with identifying new funding sources and collaborators from external sources. 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. Responsible for maintaining all study approval submissions and processes. All duties and responsibilities are performed in accordance with the Mission, Vision, and Core Values of Cayuse

Responsibilities

• Provide coordination of investigators with study site personnel
• 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
• Assist the principal investigators with assorted administrative tasks as needed
• Ability to respond quickly to unanticipated mission requirements and accurately collect and file data
• 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 a signed consent from patients and research trial candidates as required per the protocol and ensuring compliance with subject consenting and reporting of adverse events and side effects
• 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, maintain an updated and organized literature library, and ongoing 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)
• 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
• Track expenditures for all study-related activities, including supplies and equipment
• Provide inputs to final reports that document the research findings for human use protocols including, but not limited to those listed above
• Assist with the development of new studies, including assistance with writing, packaging, and submitting search study proposals. Assist with identifying new funding sources and collaborators

• Assist the Strategic Outreach Service in meeting coordination between research investigators and extramural collaborators interested in performing quality improvement/quality assurance (QI/QA) and clinical research. Coordination includes, but is not limited to, emailing involved parties, agenda creation, escorting of visiting parties, and follow-up coordination
• Notify research investigators of relevant funding opportunities, with an emphasis on the acquisition of DoD intramural funds
• Assist research investigators and their collaborators, as directed by DCI leadership, in the preparation of research proposals and protocols involving human subject clinical research coordination
• Other duties as assigned

Qualifications

Minimum Qualifications:

• Bachelor’s degree 
• 3 to 5 years of experience working in a clinical research environment
• Must be able to pass a background check. May require additional background checks as required by projects and/or clients at any time during employment.

Minimum Skills:

• Strong interpersonal skills with the ability to communicate in a professional, and articulate manner to individuals from diverse background
• Excellent verbal and written communication
• Excellent organizational, analytical, and problem-solving skills with high-level attention to detail
• Proven ability to multitask and prioritize in a fast past environment with changing priorities; adaptable to change and a quick learner
• Must be self-motivated and able to work well independently as well as on a multi-functional team.
• Ability to handle sensitive and confidential information appropriately
• Must be computer literate with proficiency and working knowledge of common database and reporting tools

Preferred Qualifications:

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

Reports to: Program Manager

Working Conditions

• Professional office environment.

• Must be physically and mentally able to perform duties while standing for extended periods of time.
• Ability to use a computer and other office productivity tools with sufficient speed to meet the demands of this position.
• Must be able to establish a productive and professional workspace.
• Must be able to sit for long periods of time looking at computer screen.
• May be asked to work a flexible schedule which may include holidays.
• May be asked to travel for business or professional development purposes.
• May be asked to work hours outside of normal business hours.

Other Duties: Please note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Affirmative Action/EEO Statement: Cayuse embraces diversity and equal opportunity in a serious way. We celebrate diversity and are committed to creating and building a team that represents a variety of backgrounds, perspectives, and skills. Cayuse, and all of its subsidiaries, are proud to be an equal opportunity workplace and are an affirmative action employer.

Pay Range