This position reports to the Director of the Human Research Protection Program. The Research Compliance Coordinator for the Human Research Protection Program (HRPP) is responsible for supporting the Institutional Review Board (IRB) administrative processes, providing pre-review of research applications as related to ethical and regulatory requirements, providing the first line of response to investigator questions or concerns, providing consultation and education to investigators related to human subjects research compliance and participating in outreach activities or other HRPP functions as needed.
Required Education and Experience:
Bachelorâ™s degree in biomedical, health-related, or regulatory field.
Three years of experience including a minimum of one year of experience in human subject research compliance and two years in a related area such as clinical trials management.
Required Special Knowledge, Skills, and Abilities:
Knowledge of the federal regulations regarding human subjects, including HHS and FDA. Ability to demonstrate analytical skills, gather, interpret, organize, and present complex research compliance data. Demonstrated success working collaboratively with interdisciplinary teams of external and internal individuals.
Must be well organized, effective at multi-tasking, and working cooperatively with others. Strong interpersonal and communication skills.
Knowledge of standard software, such as Word, Excel, Adobe and Access. Ability to multi-task and work cooperatively with others.
Preferred Education and Experience:
Masterâ™s degree in a health related or regulatory field is desired.
Certified IRB Professional (CIP).
Preferred Special Knowledge, Skills, and Abilities:
Personal or professional experience in working with people of diverse backgrounds.
Coordinates all aspects of the IRB review based on knowledge of institutional guidelines and federal regulations. Consults and advises faculty, staff, and students in the preparation of protocol applications. Provides pre-reviews of protocols including determinations of exempt status.
Provides expertise about human subjects research to investigators and committee members related to regulatory and institutional guidelines. Responsible for effective communication and timely responses related to research reviews. Responds to questions regarding the HRPP compliance program.
Provides coordination and support for the IRB. Prepares for meetings by organizing review materials, agendas, and other meeting related documents. Performs post-review functions by preparing correspondence, minutes, and other reports based upon IRB determinations. Assists supervisor in the development or modification of standard business practices and office processes related to HRPP functions.
Provides quality assurance oversight of data entry related to research submissions, reports, and notices. Maintains electronic and paper files ensuring all are accurate and complete.
Assists the supervisor in the development of training materials or administrative processes. Conducts and participates in regulatory training or outreach activities as needed. Performs other duties as assigned.
Instructions to Applicants: Applications received by Texas A&M University must either have all job application data entered or a resume attached. Failure to provide all job application data or a complete resume could result in an invalid submission and a rejected application. We encourage all applicants to upload a resume or use a LinkedIn profile to pre-populate the online application.
Internal Number: R-008624
About Texas A&M University
Texas A&M University is dedicated to the discovery, development, communication, and application of knowledge in a wide range of academic and professional fields. Its mission of providing the highest quality undergraduate and graduate programs is inseparable from its mission of developing new understandings through research and creativity. It prepares students to assume roles in leadership, responsibility, and service to society. Texas A&M assumes as its historic trust the maintenance of freedom of inquiry and an intellectual environment nurturing the human mind and spirit. It welcomes and seeks to serve persons of all racial, ethnic, and geographic groups, women and men alike, as it addresses the needs of an increasingly diverse population and a global economy. In the twenty-first century, Texas A&M University seeks to assume a place of preeminence among public universities while respecting its history and traditions.