Manager, Clinical Research Financial Operations

University of Texas at Austin•Austin, TX

1d•Onsite

About The Position

Dell Medical School is seeking a Manager, Clinical Research Financial Operations. This is a 3-year grant-funded position with an end date of September 30, 2029, renewable based on availability of funding, work performance, and progress toward goals. The Manager, Clinical Research Financial Operations manages day‑to‑day centralized clinical research operations within the Clinical Trials Office (CTO) and supports consistent execution of clinical trial workflows across participating departments. Reporting to the Senior Manager, Clinical Research Operations, this role oversees research coordinator pools and operational staff responsible for study start‑up execution, regulatory submissions, trial coordination activities, and participant recruitment support. The Manager implements standardized operational procedures, ensures compliance with federal regulations and institutional policies, and supports efficient activation and execution of clinical trials. This role collaborates closely with investigators, departmental research units, regulatory offices, research finance, and clinical operations to ensure high‑quality study conduct and operational readiness across the institutional research portfolio.

Requirements

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.

Nice To Haves

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

Responsibilities

Manages day‑to‑day operations of centralized clinical research services including study start‑up, trial coordination, regulatory workflows, and recruitment support.
Implements operational procedures, service workflows, and performance expectations established by the CTO.
Supports the development and maintenance of standard operating procedures (SOPs), job aids, and guidelines for clinical research operations.
Monitors key operational metrics such as study activation timelines, coordinator workload, regulatory submission timeliness, and enrollment progress.
Identifies process gaps and recommends operational improvements to enhance efficiency and compliance.
Supervises centralized research coordinators and operational staff, including hiring, onboarding, training, performance evaluation, and day‑to‑day oversight.
Assigns coordinator resources to studies based on protocol complexity, enrollment expectations, and departmental needs.
Ensures consistent application of operational standards, documentation practices, and participant management workflows.
Supports workforce development, competency assessment, and professional growth for coordinators and operational staff.
Contributes to workforce planning and resource‑allocation strategies to meet institutional research demands.
Oversees operational components of feasibility review, study intake, and activation readiness activities.
Coordinates with contracting, coverage analysis, budgeting, IRB, regulatory, Epic Research, and CTMS teams to ensure timely activation.
Tracks start‑up progress, monitors milestones, and identifies operational barriers affecting study initiation.
Implements activation workflows, communicates expectations to study teams, and supports continuous improvement efforts.
Oversees regulatory submission activities including initial submissions, amendments, continuing reviews, and safety reporting.
Ensures compliance with institutional policies, FDA regulations, ICH‑GCP guidance, and federal research requirements.
Supports operational readiness for audits, inspections, and sponsor monitoring visits.
Assists with oversight of investigator‑initiated studies, including documentation, compliance tracking, and submission coordination.
Supports centralized recruitment strategies and participant engagement initiatives.
Coordinates with research technology platforms including Epic Research, CTMS, and eRegulatory systems to support operational workflows.
Ensures research systems are used consistently to document study activity, support regulatory compliance, and maintain reporting accuracy.
Participates in CTMS and EHR upgrade testing, workflow redesign, and go‑live support.
Represents clinical research operations on institutional committees and cross‑functional workgroups.
Performs operational analyses to investigate defects or barriers affecting study performance.
Assists with onboarding new departments into centralized research operational workflows and systems.
Adheres to institutional internal controls and reporting structures.
Performs other related duties as assigned.