Manager, Clinical Research Financial Operations

University of Texas; Austin, Northern (TX, KY); Hybrid; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

The University of Texas at Austin is seeking a clinical operations professional to streamline study startup, regulatory submissions, and ongoing study conduct. You will collaborate with investigators, departments, and regulatory offices to ensure compliant, timely study delivery.

The role requires advanced experience in clinical research operations, regulatory management, and familiarity with CTMS, eRegulatory systems, and Epic Research. Leadership and training responsibilities are included.

Qualifikationen

• Bachelor's degree required in a related field.
• Master's degree preferred in related field.
• 5+ years in clinical research operations or related areas.
• Experience with FDA inspections or sponsor audits is a plus.

Aufgaben

• Investigates operational issues using protocol documentation, regulatory requirements, and workflow analysis.
• Implements sustainable solutions through workflow modifications and training.
• Collaborates across departments to resolve study-level obstacles.
• Supports investigators and study teams with clear processes and predictable timelines.
• Balances operational efficiency with regulatory and institutional requirements.

Kenntnisse

Clinical research operations

Regulatory management

Leadership

Ausbildung

Bachelor's degree in Healthcare Administration, Public Health, Life Sciences, Nursing/Allied Health, Business Administration, or related field

Master's degree in Healthcare Administration, Public Health, Business Administration, or related field

Tools

CTMS (OnCore)

Epic Research

eRegulatory systems

Jobbeschreibung

* Investigates operational issues using protocol documentation, regulatory requirements, and workflow analysis.* Implements sustainable solutions through workflow modifications and training.* Collaborates across departments to resolve study-level obstacles.* Supports investigators and study teams with clear processes and predictable timelines.* Balances operational efficiency with regulatory and institutional requirements.* Builds strong working relationships with clinical departments, regulatory offices, finance, and research teams.* Bachelor's degree in Healthcare Administration, Public Health, Life Sciences, Nursing/Allied Health, Business Administration, or related field.* 5 years of experience in clinical research operations, clinical coordination, start-up, regulatory management, or related clinical research activities.* Experience supporting study lifecycle activities including feasibility review, activation, study conduct, and close-out.* Experience working with CTMS, eRegulatory systems, and/or EHR research modules such as Epic Research.* Master's degree in Healthcare Administration, Public Health, Business Administration, or related field.* Supervisory experience or team-lead experience overseeing clinical research staff or operational workflows.* 7 years of experience in academic medical center or large health system research operations.* Experience scaling or supporting centralized coordinator pools, start-up units, recruitment services, or regulatory service lines.* Experience supporting FDA inspections, sponsor audits, or institutional compliance reviews.* ACRP or SOCRA certification (CCRP, CCRC, or equivalent)* CIP (Certified IRB Professional)* CRA (Certified Research Administrator)* Certification or proficiency with Epic Research, CTMS platforms (e.g., OnCore), or equivalent research systems* GCP or FDA-regulated research training/certification* Prioritizes operational work queues including start-up tasks, regulatory submissions, and coordinator assignments.* Allocates coordinator resources based on study complexity and operational need.* Implements workflow updates, training, and SOP changes within established governance.* Interprets institutional policies and regulatory guidance for routine operational scenarios.* Resolves day-to-day operational issues affecting study conduct.**Start Here, Change the World**At The University of Texas at Austin, tradition meets innovation in the heart of a city that frequents lists of the best places to live and work. Named by Forbes as one of America's Best Large Employers for the sixth year in a row in 2025, UT offers both a dynamic work environment and a gateway to vibrant local culture. Whether you're at the forefront of the student experience, conducting world-changing research or supporting the engine that drives Texas' flagship university, working at UT means making a lasting impact on our city, our state and our world.Our more than 20,000 faculty and staff empower 55,000+ students to challenge ideas, pursue passions and shape their futures. Joining UT, you'll become part of a community dedicated to making a meaningful impact on campus and throughout the world.Please see our .**Comments and Inquiries:**Email comments to [e-mail]. For questions or concerns regarding equal opportunity only, contact .Additional information for applicants can be found on the Human Resources web page:. For more job information, call the Human Resource Service Center at [phone], or toll-free at [phone].