The Research Compliance Coordinator for the Human Research Protection Program (HRPP) is responsible for: providing first line response to questions and concerns from investigators, the Institutional Review Board (IRB); providing key support to the HRPP and accreditation related activities; and coordinating HRPP outreach and education initiatives.
Required Education and Experience:
Bachelorâ™s degree in biomedicine or a 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 is a must.
Demonstrated success working collaboratively with interdisciplinary teams of external and internal individuals.
Must be well organized, effective at multi-tasking and work 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.
Preferred Licenses and Certifications:
Certified IRB Professional (CIP)
Preferred Special Knowledge, Skills, and Abilities:
Personal or professional experience in working with people of diverse backgrounds.
Coordination and Protocol Review - Coordinates all aspects of the HRPP reviews based on knowledge of institutional guidelines and federal regulations. Consults and advises faculty, staff and students in the preparation of protocols. Provides preliminary reviews of protocols including determinations of exempt status, in order to give feedback to the customer to improve the product.
HRPP Resources & Contact - Provides expertise about research with human subjects for investigators and committee members related to compliance guidance. Responsible for effective communication and timely responses related to compliance reviews, including issues of non-compliance. Responds to question regarding the compliance program.
IRB Support - Provides coordination and support for the IRB committee, prepares for meetings by organizing review materials, reports, and other meeting related documents. Reviews/prepares correspondence and minutes based on committee decisions. Assists supervisor in the development or modification of standard business practices and office processes related to compliance. Creates draft correspondence and distributes as appropriate.
Records Management - Provides quality assurance oversight of data entry related to document submissions, reports, and notices. Maintains electronic and paper files ensuring all are up-to-date and complete.
Training and Development - Assists supervisor in the development of training materials and conducts regulatory training as needed. Assists supervisor in the development or modification of standard business practices and office processes related to the HRPP including the IRB.
Other Duties - 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-002071
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.