Manager, Clinical Research Operations

University of Texas at Austin; Austin (TX); Vor Ort; USD 80.000 - 97.000; Vollzeit

Zusammenfassung

University of Texas at Austin's Dell Medical School seeks a Manager, Clinical Research Operations to oversee centralized clinical research operations and study activation across departments. This 3-year grant-funded role reports to the Senior Manager and emphasizes standardized procedures and regulatory compliance.

The position leads coordinator pools, supports feasibility reviews, regulatory submissions, and participant recruitment while collaborating with investigators, regulatory offices, and

Qualifikationen

• Bachelor's degree and 5 years in clinical research operations.
• Experience with study lifecycle activities including feasibility review, activation, study conduct, and closeout.
• Experience working with CTMS and EHR research modules.

Aufgaben

• Oversees day-to-day centralized clinical research operations and recruitment support.
• Coordinates regulatory submissions and activation with related teams.
• Monitors activation timelines, enrollment progress, and compliance.
• Develops SOPs, job aids, and training materials.
• Manages centralized research coordinators and staffing resources.

Kenntnisse

Integrity and Trust

Process Management

Managing and Measuring Work

Dealing with Ambiguity

Communicating Effectively

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

ACRP or SOCRA certification (CCRP, CCRC, or equivalent)

CIP (Certified IRB Professional)

CRA (Certified Research Administrator)

Tools

Epic Research

CTMS (OnCore)

eRegulatory systems

Jobbeschreibung

Job Posting Title

Manager, Clinical Research Operations

Hiring Department

Dell Medical School

Position Open To

All Applicants

Weekly Scheduled Hours

40

FLSA Status

Exempt from FLSA

Earliest Start Date

Immediately

Position Duration

Expected to Continue Until Sep 30, 2029

Location

AUSTIN, TX

Job Details

General Notes

Dell Medical School is seeking a Manager, Clinical Research 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.

Purpose

The Manager, Clinical Research Operations manages daytoday centralized clinical research operations 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 startup 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 highquality study conduct and operational readiness across the institutional research portfolio.

ESSENTIAL JOB FUNCTIONS

Operational Oversight & Process Implementation

• Manages daytoday operations of centralized clinical research services including study startup, 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.

Research Coordinator Pool Management & Workforce Support

• Supervises centralized research coordinators and operational staff, including hiring, onboarding, training, performance evaluation, and daytoday 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 resourceallocation strategies to meet institutional research demands.

Clinical Trial Start-Up & Study Activation Coordination

• 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 startup progress, monitors milestones, and identifies operational barriers affecting study initiation.
• Implements activation workflows, communicates expectations to study teams, and supports continuous improvement efforts.

Regulatory Support & Compliance Monitoring

• Oversees regulatory submission activities including initial submissions, amendments, continuing reviews, and safety reporting.
• Ensures compliance with institutional policies, FDA regulations, ICHGCP guidance, and federal research requirements.
• Supports operational readiness for audits, inspections, and sponsor monitoring visits.
• Assists with oversight of investigatorinitiated studies, including documentation, compliance tracking, and submission coordination.

Recruitment Support & Research Systems Integration

• 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.

Marginal or Periodic Functions

• Participates in CTMS and EHR upgrade testing, workflow redesign, and golive support.
• Represents clinical research operations on institutional committees and crossfunctional 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.

KNOWLEDGE/SKILLS/ABILITIES

Integrity and Trust

• Handles confidential participant, institutional, and regulatory information responsibly.
• Escalates potential noncompliance promptly and documents appropriate operational decisions.
• Maintains transparency while safeguarding PHI and sensitive research information.

Process Management

• Implements standardized workflows to support efficient clinical trial execution.
• Supports process improvements and updates SOPs, job aids, and training materials.
• Works with Research IT and operational teams to optimize CTMS, EHR research modules, and eRegulatory workflows.

Managing and Measuring Work

• Monitors operational performance and ensures service levels are met.
• Tracks workload distribution across coordinator pools and operational teams.
• Uses performance metrics to identify improvement needs and coach staff.

Problem Solving

• Investigates operational issues using protocol documentation, regulatory requirements, and workflow analysis.
• Implements sustainable solutions through workflow modifications and training.
• Collaborates across departments to resolve studylevel obstacles.

Customer Focus

• 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.

Communicating Effectively

• Communicates clearly with investigators, coordinators, staff, sponsors, and institutional partners.
• Translates regulations and institutional policies into actionable operational guidance.
• Presents operational updates and findings to leadership as needed.

Dealing with Ambiguity

• Maintains effectiveness in dynamic, evolving research environments.
• Provides guidance on complex studies and operational decisions with incomplete information.
• Helps maintain operational continuity during system changes or workflow transitions.

EDUCATION & EXPERIENCE

Minimum Qualifications

• 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, startup, regulatory management, or related clinical research activities.
• Experience supporting study lifecycle activities including feasibility review, activation, study conduct, and closeout.
• Experience working with CTMS, eRegulatory systems, and/or EHR research modules such as Epic Research.

Preferred Qualifications

• 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, startup units, recruitment services, or regulatory service lines.
• Experience supporting FDA inspections, sponsor audits, or institutional compliance reviews.

LICENSES, REGISTRATIONS OR CERTIFICATIONS

Required

• None

Preferred

• 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 FDAregulated research training/certification

Salary Range

$88,516 + depending on qualifications

SUPERVISION *Required for Supervisor and above job descriptions

Direct supervision: Clinical Research Operations Analysts (I-III)

BUDGET RESPONSIBILITY *Required for Associate Director and above job descriptions

• N/A

DECISION-MAKING RESPONSIBILITY *Required for Supervisor and above job descriptions

Autonomous Decisions

• Prioritizes operational work queues including startup 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 daytoday operational issues affecting study conduct.

Requires HigherLevel Approval

• Initiates formal regulatory or compliance escalations.
• Approves significant operational changes affecting enterprise research systems.
• Recommends major changes to institutional coordinator models or operational procedures.
• Approves major resource reallocations, expansion requests, or new service line development.

WORKING ENVIRONMENT/EQUIPMENT

• Standard office environment
• Repetitive use of keyboard and computer
• May have occasional exposure to clinical environments or occupational hazards (e.g., PHI, radiation, hazardous medications, or patient interactions)

Required Materials

• Resume/CV
• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest

Employment Eligibility

Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval.

Retirement Plan Eligibility

The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.

Background Checks

A criminal history background check will be required for finalist(s) under consideration for this position.

Equal Opportunity Employer

The University of Texas at Austin, as an equal opportunity/affirmative action employer,complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.

Pay Transparency

The University of Texas at Austin will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

Employment Eligibility Verification

If hired, you will be required to complete the federal Employment Eligibility Verification I-9 form. You will be required to present acceptable and original documents to prove your identity and authorization to work in the United States. Documents need to be presented no later than the third day of employment. Failure to do so will result in loss of employment at the university.

E-Verify

The University of Texas at Austin use E-Verify to check the work authorization of all new hires effective May 2015. The university's company ID number for purposes of E-Verify is 854197. For more information about E-Verify, please see the following:

• E-Verify Poster (English and Spanish) [PDF]
• Right to Work Poster (English) [PDF]
• Right to Work Poster (Spanish) [PDF]

Compliance

Employees may be required to report violations of law under Title IX and the Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act (Clery Act). If this position is identified a Campus Security Authority (Clery Act), you will be notified and provided resources for reporting. Responsible employees under Title IX are defined and outlined in HOP-3031.

The Clery Act requires all prospective employees be notified of the availability of the Annual Security and Fire Safety report. You may access the most recent report here or obtain a copy at University Compliance Services, 1616 Guadalupe Street, UTA 2.206, Austin, Texas 78701.