Regulatory Assistant, Psychiatry, Mood Disorders Job at UT Southwestern
Departmental Description
At UT Southwestern’s Center for Depression Research and Clinical Care (CDRC), we believe that a future free from the burden of emotional and behavioral disorders is possible. Our mission is exemplified by the extensive research done in the center on methods to prevent and treat depression and associated disorders, including bipolar, anxiety, and substance use disorders.
The Center for Depression Research and Clinical Care (CDRC) conducts many large scale studies funded by NIH, PCORI, American Foundation for Suicide Prevention, as well as state and local programs funded by the State of Texas and foundations. This position will assist with the coordination of these research projects.
Job Duties
Works under direct supervision to assist management with administrative and/or business functions to assure compliance with federal regulations relating to human subject research and/or animal care and use. Understands and applies multiple regulations to complex scientific research projects.
Review Modification requests, as well as associated study protocols, informed consent documents, and other study-related documentation, to assure conformance with all applicable requirements. Seek consultation from IRB/IACUC Chairs, and communicate determinations to PI's and research staff. Manage information in database and produce related reports as required.
Review Adverse Event reports to assure conformance with all applicable requirements. Seek consultation from IRB/IACUC Chairs, as necessary, and communicate determinations to PI's and staff. Manage adverse event information in database and produce related reports as required.
Provide consultation and technical assistance to investigators and study personnel regarding requirements for Modification and/or Adverse Event submissions, performance of studies, and documentation of compliance. Serve as an information resource to the campus about human subject protection and/or animal care and use.
Provide administrative support for IRB/IACUC Coordinators, including, but not limited to: managing reviews for expedited studies; preparing approval packets including approval letters, stamping and copying study documents and notifying study personnel of completion; processing full-board study continuing review submissions, including review of submissions for completeness; data entry; communication with study personnel for clarifications or to request missing documents; and preparing assignment of studies to appropriate board or committee.
Monitor automatic continuing review reminders on a daily basis, prepare and send study lapse letters. Complete study closures through ERGO.
Assist with development of and/or updates to IRB/IACUC guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities.
Perform other duties as assigned.
Experience and Education
High School graduate or GED and four (4) years of related experience required.
May consider education in lieu of experience.
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.
To learn more, please visit: why-work-here/diversity-inclusion
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At UT Southwestern’s Center for Depression Research and Clinical Care (CDRC), we believe that a future free from the burden of emotional and behavioral disorders is possible. Our mission is exemplified by the extensive research done in the center on methods to prevent and treat depression and associated disorders, including bipolar, anxiety, and substance use disorders.
The Center for Depression Research and Clinical Care (CDRC) conducts many large scale studies funded by NIH, PCORI, American Foundation for Suicide Prevention, as well as state and local programs funded by the State of Texas and foundations. This position will assist with the coordination of these research projects.
Job Duties
Works under direct supervision to assist management with administrative and/or business functions to assure compliance with federal regulations relating to human subject research and/or animal care and use. Understands and applies multiple regulations to complex scientific research projects.
Review Modification requests, as well as associated study protocols, informed consent documents, and other study-related documentation, to assure conformance with all applicable requirements. Seek consultation from IRB/IACUC Chairs, and communicate determinations to PI's and research staff. Manage information in database and produce related reports as required.
Review Adverse Event reports to assure conformance with all applicable requirements. Seek consultation from IRB/IACUC Chairs, as necessary, and communicate determinations to PI's and staff. Manage adverse event information in database and produce related reports as required.
Provide consultation and technical assistance to investigators and study personnel regarding requirements for Modification and/or Adverse Event submissions, performance of studies, and documentation of compliance. Serve as an information resource to the campus about human subject protection and/or animal care and use.
Provide administrative support for IRB/IACUC Coordinators, including, but not limited to: managing reviews for expedited studies; preparing approval packets including approval letters, stamping and copying study documents and notifying study personnel of completion; processing full-board study continuing review submissions, including review of submissions for completeness; data entry; communication with study personnel for clarifications or to request missing documents; and preparing assignment of studies to appropriate board or committee.
Monitor automatic continuing review reminders on a daily basis, prepare and send study lapse letters. Complete study closures through ERGO.
Assist with development of and/or updates to IRB/IACUC guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities.
Perform other duties as assigned.
Experience and Education
High School graduate or GED and four (4) years of related experience required.
May consider education in lieu of experience.
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.
To learn more, please visit: why-work-here/diversity-inclusion
Please Note :
bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.