Summary

The Lead Quality Assurance and Control position oversees QAQC functions, ensuring compliance with NIH and CTSA guidelines. This role involves collaborating with NIH and partner institutions, organizing grant programs, and performing quality reviews of submissions. Additionally, the position serves as a liaison to align operational procedures, communicate updates, and drive process improvements. The role also acts as the hub liaison in support of the Consortium for Translational & Precision Health (CTPH).

Job Duties

Quality Assurance and Quality Control (75%)

• Leads the QAQC functions, including interactions with NIH and other partner institutions to ensure compliance with the NIH, CTSA award letter.
• Collaborates with the National Institutes of Health (NIH) and other stakeholders (internal and external) to meet funding requirements, reporting standards, and regulatory guidelines.
• Organizes and assists with CTSA pilot and CTS research grant programs including posting solicitations, organizing grant review meetings, preparing pre and post meeting materials, sharing feedback with applicants and ensuring ongoing tracking of funded projects.
• Ensures the submission of successful CTSA-related information packages to NCATS (with a specific focus on submissions of pilots and element E projects conducting research with human subjects).
• Performs quality reviews of CTSA-related submissions to NCATS. o Performs submissions to the eRA Human Subjects System (for prior approval of research with Human Subjects), submissions of proposed live vertebrate animal research for prior approval, and management of the overall quality review and submission process.
• Serves as a liaison between BCM and partner organizations to align operational procedures, share best practices, and address compliance challenges.
• Effectively communicates to all stakeholders of updates to CTSA/CTPH - NIH policies, funding guidelines, or research mandates.
• Analyzes QAQC metrics to identify process improvements that streamline workflows without compromising quality.
• Provides training and resources to teams across institutions to maintain consistent compliance and operational excellence.
• Recommends and drive initiatives that enhance grant preparation, submission, and success based on evaluated QAQC measures.
• Prepares annual NIH progress reports.

HUB Liaison (25%)

• Organizes and administers the hub liaisons team including faculty leads and other staff to support scientific, training, governance, workgroup, and other types of CTSA consortium activities.
• Facilitates collaboration with different teams at BCM and partnering institutions. This role will interface with the BCM Office of Research, University of Houston and several CTPH affiliates.
• Functions as an interface between the CTSA hub and the national collaborative activities of the CTSA Program as well as be the primary source of dissemination, to these activities, in terms of their hub’s unique strengths and capabilities.
• Identification and dissemination of innovations in clinical trials both internally and externally.
• Performs other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Six years of relevant experience.

Preferred Qualifications

• Experience with CTSA
• Experience with research quality