JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Quality Assurance and Regulatory Coordinator is housed in at UT Health Science Center, Graduate School of Medicine’s Office of Research Support. This position provides support to the GSM Director of Research for all Quality Assurance activities relating to investigator-initiated research and other academic research projects. The responsibilities include post-IRB approval monitoring and review of investigator-initiated research for quality, data integrity, and participant safety. This position will also serve as a regulatory specialist to support investigators with local and central IRB, FDA (IND), and other regulatory submission activities to ensure compliance with regulations and laws (GCP, CMS, FDA, OHRP, NIH).

DUTIES AND RESPONSIBILITIES:

1. Verifies all components of the study are conducted according to the approved protocol and any amendments.
2. Review studies to ensure compliance with institutional, local, state, and federal regulations, including IRB and FDA requirements.
3. Collaborates with investigators prior to study initiation to review institutional Standard Operating Procedures for research implementation, management, and investigator responsibility.
4. Ensures the accuracy, completeness, and reliability of data collection.
5. Ensures adverse events are reported properly and per local and federal policy.
6. Prepares and submits required reports to institutional stakeholders, providing feedback on study performance and any QA issues.
7. Collaborates with investigators to generate regulatory systems that meet institutional, local, and federal policies and generates the documents needed to submit local and central IRB applications and other regulatory submissions.
8. Identifies potential risks to participants and data quality and implements strategies to mitigate these risks prior to participant enrollment.
9. Works closely with institutional review boards, data safety monitoring boards, and other stakeholders to ensure oversight and compliance.
10. Assists the Director of Research with providing training for research staff on study protocols, ethical considerations, and QA practices.
11. Coordinates logistical components of compliance meetings with investigators and study team members.
12. Performs other duties as required.

MINIMUM REQUIREMENTS:

EDUCATION: Bachelor's Degree in a Health-related field. (TRANSCRIPT REQUIRED)

EXPERIENCE: Four (4) years of hands-on experience in clinical research including roles such as clinical research coordinator or monitor and experience in the preparation or submission of Investigational New Drug Applications; OR Master's Degree and two (2) years of hands-on experience in clinical research.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other relevant regulatory frameworks.
• Experience in conducting audits, including knowledge of audit methodologies and standards.
• Strong analytical skills and attention to detail to identify discrepancies and areas for improvement.
• Excellent verbal and written communication skills to interact with study teams, present findings, and provide training.