Under supervision of the IRB Administrator, this position is responsible for supporting the Alaska Area Institutional Review Board (AAIRB) privileged and confidential review and approval process of all proposed research activities involving human subjects in the Alaska Tribal Health System by serving the Tribal Health Organizations. This position also maintains records of AAIRB functions, operations and activities. The following duties are intended to provide a representative summary of the major duties and responsibilities and ARE NOT intended to serve as a comprehensive list of all duties performed by all employees in this classification. Incumbent(s) may not be required to perform all duties listed and may be required to perform additional, position-specific duties. Level I employees perform work under close supervision, may only perform simple or routine aspects or the position, and generally require a good deal of instruction and/or training. Level III employees perform high level, complex, and responsible tasks within this position, train lower level employees, and generally work with minimum supervision and follow-up from their supervisor. REPRESENTATIVE DUTIES All Levels: Reviews all submissions for completeness and identifies regulatory concerns prior to review by the AAIRB. Works with the IRB Chair(s) and members to ensure that all research and related items submitted to the IRB are processed in accordance with IRB policy and procedures. Communicates IRB determinations to relevant parties. Coordinates and implements the daily activities of the AAIRB to ensure compliance with all applicable state and federal regulations for the protection of human subjects participating in clinical research. Oversees committee meetings. Files regulatory documents appropriately to maintain accurate records of all IRB activities, including drafting of agenda and meeting minutes. Manages communications between the IRB and other stakeholders. Assists in creating and revising of policies and procedures. Develops and presents continuing education resources for AAIRB members. Occasional travel to participate in local and out of state research conferences; and to provide trainings on federal regulations that protect people in research. Responsible for maintaining a teamwork-oriented environment. Performs other duties as assigned or required. IRB Coordinator: Contributes to efficient processing of study documentation and appropriate management of data systems (share folders and electronic IRB submission system). Maintains system integrity of database for tracking studies and IRB submissions. Performs pre-committee analysis of research proposals. 

Identifies external committee consultants, auditors and other experts to review a submitted study. Coordinates with other institutions to obtain vital committee review information. Participates in continuing education to keep current with IRB developments. Processes proposed regulations for program impacts. Assists in the development of IRB policies and procedures. Serves as a resource to the human subjects’ protection program. Works with the HRPP Administrator to provide educational sessions for investigators, administrators, and other research support personnel. Complies with daily operational procedures for the efficient processing of research. IRB Analyst: Facilitates compliance with institutional policies, federal, state, and local regulations governing the protection of human research participants. Ensures ethical conduct of human participant research. Serves as an educational resource for IRB members, investigators, research personnel, and students. Manages training and quality improvement activities for human subject protection program. Participates in convened meeting deliberations. Processes caseload of applications related to human subjects research projects submitted for Institutional Review Board (IRB) review. Evaluates AAIRB workflow; identifies and implements ways to improve the procedure under the direction of the Administrator and the Board. Serves as an alternate IRB member.

Required Skills

• Knowledge of Alaska Tribal Health System, ANTHC, and Alaska Native culture(s) and politics. • Knowledge of standard regulations and principles of research programs. • Knowledge and proficiency with MS Office programs, MS Windows operating system and Adobe Acrobat • Skill in oral and written communication • Skill in providing excellent customer service. • Skill in establishing and maintaining cooperative working relationships with others. • Skill in assessing and prioritizing multiple tasks, projects and demand and meeting deadlines. • Skill in utilizing various IRB-related systems. IRB Coordinator: • Knowledge of the federal and state laws and regulations governing the conduct of research with human subjects and CITI Human Subjects training modules. • Skill in working in online environments – applications, databases, share points and share drives. • Skill in working independently. IRB Analyst: • Knowledge of medical terminologies. • Knowledge of institutional policies and procedures pertaining to IRB review of human participant research. • Knowledge of research administration, institutional review boards, or human subject protections. • Skill in conducting pre-review of biomedical and social/behavioral research proposals. • Skill in critical thinking and analyzing complex situations. • Skill in guiding IRB members, chairs, investigators, research staff, and students in how to apply the regulations • Skill in tracking review progress.

• Skill in analyzing complex problems, requiring the use of scientific, mathematical, or technical principles and in depth, experience based cross-functional knowledge.

Required Experience

MINIMUM EDUCATION QUALIFICATION All

A high school diploma or GED equivalent. IRB Coordinator Bachelor’s Degree in Political Science, Economics, Public Affairs, Political Communications, Health Care Administration, Public Policy, Public Administration, Business, Rural Development, or Social Services. Progressively responsible professional work-related experience, education, or training may be substituted on a year-for-year basis for college education. IRB Analyst Master’s Degree in Political Science, Economics, Public Affairs, Political Communications, Health Care Administration, Public Policy, Public Administration, Business, Rural Development, or Social Services. Progressively responsible professional work-related experience, education, or training may be substituted on a year-for-year basis for college education. MINIMUM EXPERIENCE QUALIFICATION All: Non-supervisory – Two (2) years of technical writing, program administration, office management, health and research-related or grant management experience. An equivalent combination of relevant education and/or training may be substituted for experience. IRB Coordinator: Non-supervisory - Three (3) years of IRB experience, health and research-related or grant writing experience. An equivalent combination of relevant education and/or training may be substituted for experience. IRB Analyst: Non-supervisory - Five (5) years of IRB experience working in an IRB office or in the conduct of research studies. An equivalent combination of relevant education and/or training may be substituted for experience.

PREFERRED EDUCATION QUALIFICATION IRB Associate – Associate’s degree PREFERRED EXPERIENCE QUALIFICATION IRB Associate - Experience working in an IRB and or a regulatory compliance position. PREFERRED CERTIFICATION QUALIFICATION Human Studies Research modules in the CITI program. Revised Common Rule Modules in CITI. Certified IRB Professional (CIP) ADDITIONAL REQUIREMENTS N/A WORKING CONDITIONS The following demands are representative of those that must be met by an employee to successfully perform the essential functions of this job: Must be able to lift approximately 20 pounds. ANMC is not a latex free facility; an employee should expect to work in an environment where latex may be present. Travel in and outside of Alaska. May be required to work outside the traditional work schedule. May be called out to work off-shift in emergency situations.

• Knowledge of Alaska Tribal Health System, ANTHC, and Alaska Native culture(s) and politics. • Knowledge of standard regulations and principles of research programs. • Knowledge and proficiency with MS Office programs, MS Windows operating system and Adobe Acrobat • Skill in oral and written communication • Skill in providing excellent customer service. • Skill in establishing and maintaining cooperative working relationships with others. • Skill in assessing and prioritizing multiple tasks, projects and demand and meeting deadlines. • Skill in utilizing various IRB-related systems. IRB Coordinator: • Knowledge of the federal and state laws and regulations governing the conduct of research with human subjects and CITI Human Subjects training modules. • Skill in working in online environments – applications, databases, share points and share drives. • Skill in working independently. IRB Analyst: • Knowledge of medical terminologies. • Knowledge of institutional policies and procedures pertaining to IRB review of human participant research. • Knowledge of research administration, institutional review boards, or human subject protections. • Skill in conducting pre-review of biomedical and social/behavioral research proposals. • Skill in critical thinking and analyzing complex situations. • Skill in guiding IRB members, chairs, investigators, research staff, and students in how to apply the regulations • Skill in tracking review progress.

• Skill in analyzing complex problems, requiring the use of scientific, mathematical, or technical principles and in depth, experience based cross-functional knowledge.