Human Research Protection Program Coordinator - Research Compliance & Biosafety Program

Job Title

Human Research Protection Program Coordinator

Agency

Texas A&M University

Department

Research Compliance & Biosafety Program

Proposed Minimum Salary

Commensurate

Job Location

College Station, Texas

Job Type

Staff

Job Description

Who We Are

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.

What We Want

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.

What You Need To Know

Salary: Commensurate

Special Note: A cover letter and resume are strongly recommended.

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.

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.