Essential Duties: Under general direction services as the primary regulatory resource for investigators and staff. Primary coordination responsibilities include dissemination of information about and assistance to investigators in the preparation of IRB applications. The position coordinates the preparation of applications for presentation to the IRBs and will independently determine the adequacy of the application and the level of review required (exempt, expedited, full board).
Screen new and renewable applications; contact and advice investigators in preparation and completion of application process
Prepare meeting agendas, assigns applications to IRB committee(s)
Prepares IRB member packets and distributes them prior to the IRB meeting.
Maintains study annual renewal system to include preparation of tickler reports
Preparation and dissemination of reminders and appropriate forms, advises investigators and staff as required.
Closes out study applications to include appropriate forms and preparation of files for final reports for closure
Prepares study withdrawal applications when required
Prepares and finalizes applications to include filing
Prepare IRB meeting minutes
Prepares and distributes IRB meeting approval, renewal, termination, and contingent approval letters.
Assist other coordinators when necessary with similar duties
Handles general office procedures (filing, answering and responding to telephone calls, filing, copying, etc.
Other duties or special projects as assigned
Knowledge and Abilities:
Ability to guide the research community members, communicating detailed information professionally and with brevity, both orally and in writing.
Ability to extrapolate requirements from regulation and IRB Policies and Procedures and provide guidance for the research community.
Ability to plan and present educational sessions to diverse groups of students, faculty, staff and others.
Ability to adapt to new, various software and applications.
Ability to work effectively under deadlines, often in a high-pressure environment.
Ability to work and make decisions independently, as appropriate.
Bachelor's degree required or 5 years of experience in Institutional Review Board (IRB) operations and other areas such as compliance, regulatory affairs, and client education with the required skill sets as described:
Knowledge of human subjects regulatory compliance;
Exceptional computer skills including word processing, spreadsheet creation and maintenance, database management, and proficiency using research software system;
Effective communication and presentation skills.
At least two years of experience in an IRB office preferred.
CHRISTUS HEALTH is an international Catholic, faith-based, not-for-profit health system comprised of almost more than 600 services and facilities, including more than 60 hospitals and long-term care facilities, 350 clinics and outpatient centers, and dozens of other health ministries and ventures. CHRISTUS operates in 6 U.S. states, Colombia, Chile and 6 states in Mexico. To support our health care ministry, CHRISTUS Health employs approximately 45,000 Associates and has more than 15,000 physicians on medical staffs who provide care and support for patients. CHRISTUS Health is listed among the top ten largest Catholic health systems in the United States.