Qualifications
- Required Education and Experience
- Bachelor’s degree in science, biomedical, health-related, or regulatory field.
- Three years of experience in compliance/regulations, auditing, legal work, research, medical, scientific writing, clinical trials or related.
Preferred Qualifications
- Master’s degree in health related or regulatory field.
- A minimum of one year of experience in human subject research compliance and two years in a related area such social & behavioral or biomedical research or clinical trials management.
- Certified IRB Professional (CIP) or Certified Clinical Research Professional (CCRP)
- 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. 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.
Responsibilities
- Coordination and Protocol Review
- 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.
- HRPP Resources & Contact
- 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.
- IRB Support
- 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.
- Records Management
- 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.
- Training and Development
- Assists the supervisor in the development of training materials or administrative processes.
- Conducts and participates in regulatory training or outreach activities as needed.
- Why Texas A&M University?
We are a prestigious university with strong traditions, Core Values, and a community of caring and collaboration. Amenities associated with a major university, such as sporting and cultural events, state-of-the-art recreation facilities, the Bush Library and Museum, and much more await you. Experience all that a big city has to offer but with a reasonable cost-of-living and no long commutes.
Medical, prescription drug, dental, vision, life and AD&D, flexible spending accounts , and long-term disability insurance with Texas A&M contributing to employee health and basic life premiums
- 12- 15 days of annual paid holidays
- Up to eight hours of paid sick leave and at least eight hours of paid vacation each month
- Automatic enrollment in the Teacher Retirement System of Texas
- Health and Wellness: Free exercise programs and release time
- Professional Development: All employees have access to free LinkedIn Learning training, webinars, and limited financial support to attend conferences, workshops, and more
- Educational release time and tuition assistance for completing a degree while a Texas A&M employee
- Living Well, a program at Texas A&M that has been built by employees, for employees
Our Commitment
Texas A&M University is committed to enriching the learning and working environment by promoting a culture that respects all pers p ectives, talents & lived experience s . Embracing varying opinions and perspectives strengthens our core values which are: Respect, Excellence, Leadership, Loyalty, Integrity, and Selfless Service .
All positions are security-sensitive. Applicants are subject to a criminal history investigation, and employment is contingent upon the institution’s verification of credentials and/or other information required by the institution’s procedures, including the completion of the criminal history check.
Equal Opportunity/Veterans/Disability Employer.
