Human Research Protection Program Coordinator

Texas A&M • College Station, TX

3d • Onsite

About The Position

The Human Research Protection Program (HRPP) supports Texas A&M University's commitment to excellence in research by helping ensure studies involving human participants are conducted ethically, responsibly, and in compliance with regulatory requirements. Through collaboration, education, and service, we empower researchers to make meaningful discoveries while safeguarding the individuals who make that research possible. We are seeking a collaborative and detail-oriented professional who is passionate about supporting ethical, high-quality research. The ideal candidate brings a master's degree in a health-related or regulatory field, experience in human subjects research compliance and related areas such as social and behavioral research, biomedical research, or clinical trials management, and a professional certification such as a Certified IRB Professional (CIP) or Certified Clinical Research Professional (CCRP). Successful candidates enjoy interpreting complex requirements, providing exceptional customer service, building strong partnerships with faculty, staff, and students, and serving as a trusted resource on research compliance matters. If you thrive in a fast-paced environment, can balance multiple priorities, and are motivated by helping researchers advance meaningful discoveries while protecting the rights and welfare of research participants, we'd love to hear from you.

Requirements

• 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.
• 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.

Nice To Haves

• 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).

Responsibilities

• 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.

Benefits

• 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
• Free exercise programs and release time
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level