Institutional Review Board Coordinator
Performs advanced (senior-level) consultative services and technical assistance work in order to administer and coordinate all functions of the Institutional Review Board (IRB). This includes receiving and reviewing research proposals for completeness and adherence with IRB policies, institutional requirements, and State/Federal codes, rules, and regulations (45 CFR 46). Work involves planning, developing, and implementing IRB policies and procedures and providing technical assistance to agency staff, other HHS agencies, universities, researchers/principal investigators, students, and the public. Maintains records of all activities and communications, writes minutes and reports on the activities of the IRB. Provides orientation and training to all IRB committee members to maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to the protection of human subjects and privacy and to avoid conflict of interests. Works under general supervision of the Research Advancement Manager and Director of Public Health Research Advancement with moderate latitude for the use of initiative and independent judgment.
Essential Job Functions:
EJF.1. (40%) Responsible for the operation and functions of the current DSHS IRB and any other similar review committee established by the agency. Required to follow through from time of submission to final resolution by the IRB, including studies requiring exempt, expedited or full board review as well as follow-up on studies needing to be renewed or to report on the conclusion of their studies. Provides regulatory guidance to IRB members, investigators, and research staff related to the protection of human subjects as well as to recognize and avoid conflicts of interest situations. Works closely with the IRB chair and executives regarding research related and privacy policies and procedures. Serves as a liaison between DSHS and its staff, other HHS agencies, universities, researchers/principal investigators, students, and the public. Provides timely and accurate guidance to investigators on the preparation and submission of new protocol applications or protocol revisions and serves as a resource to the IRB members in the review of protocol application process and fulfilling their IRB roles and responsibilities. Conducts investigations and reviews to assist the IRB members in their determinations. Schedules, prepares, and coordinates the IRB review process of protocol applications as well as in the preparations for meetings. Communicates with IRB applicants on the status and determinations made by the IRB including providing timely and accurate IRB correspondence. Researches and prepares instructional materials and maintains websites and e-mail distribution list of board members and program subject matter experts.
EFJ.2. (30%) Produces documents that interpret and describe the IRB committee policies and procedures. Develops and maintains the Standard Operating Procedures Manual. Develops and updates agency standards, rules, policies, and procedures for review committees in compliance with state and federal law. Plans and implements process improvements and monitors compliance with state and federal laws and regulations and agency policies. Publicizes and evaluates communication and workflow process. Works with managers, program coordinators, and staff to ensure uniformity of review of potential protocol applications and data requests and compliance with standard operating procedures and in accordance with state and federal regulations. Monitors legislation, prepares analysis reports, conducts research, and serves as a conduit of information on new laws and trends affecting the way DSHS handles the IRB. Reviews program area functions and operations, plans and prepares required performance reports, identifies areas needing change, and develops and implements plans to improve the program and address areas of concern. Uses computer and informatics technology to enhance program operations and productivity.
EFJ.3. (20%) Tracks and maintains the IRB database established by the agency. Prepares summary, analytic, and activity reports of the IRB activities. Serves as a liaison to staff, government agencies, community organizations, universities, and the general public to explain and provide assistance, technical or otherwise, on program specifics and requirements. Serves on interagency teams as needed.
EFJ. 4. (10%) Other duties as assigned related to data sharing and research committees, policies, and practices. May include but are not limited to actively participating and/or serving in a supporting role to meet the agency’s obligations for disaster response and/or recovery or Continuity of Operations (COOP) activation. The Center for Public Health Policy and Practice is an active partner in response activities. Such participation may require an alternate shift pattern assignment and/or location.
Knowledge Skills Abilities:
Knowledge of state rules and laws and federal regulations relating to the IRB process.
Knowledge of social, behavioral, educational and health science research.
Knowledge of principles and practices of public administration and management.
Knowledge of project management principles and tools.
Knowledge of program planning, implementation, analysis, and evaluation.
Knowledge of publications process at DSHS or within state government.
Skill in using web development tools.
Skill in using Microsoft Office (Word, Access, Excel, PowerPoint) and Internet searching.
Skill in the use of the computer and informatics technology to enhance program operations and productivity.
Skill in written and verbal communication.
Registration or Licensure Requirements:
NA
Initial Selection Criteria:
Bachelor’s degree required.
Additional Information:
Requisition # 608359
MOS Code:
Note: There are no direct military occupation(s) that relate to the responsibilities, and registration or licensure requirements for this position. All active duty, reservists, guardsmen, and veterans are encouraged to apply if they meet the qualifications for this position.
HHS agencies use E-Verify. You must bring your I-9 documentation with you on your first day of work.
In compliance with the Americans with Disabilities Act (ADA), HHS agencies will provide reasonable accommodation during the hiring and selection process for qualified individuals with a disability. If you need assistance completing the on-line application, contact the HHS Employee Service Center at 1-888-894-4747. If you are contacted for an interview and need accommodation to participate in the interview process, please notify the person scheduling the interview.
Top 10 Tips for Success when Applying to Jobs at HHSC and DSHS