Research Operations Manager, Res, Reg, & Compliance (Hybrid)

University of Texas Medical Branch at Galveston

Galveston, TX

JOB DETAILS
SKILLS
Academic Background, Academic Research, Accounting, Accreditation Standards, Administrative Skills, Analysis Skills, Benchmarking, Budgeting, Business Strategy, Clinical Information, Clinical Monitoring, Clinical Research, Clinical Trial, Coaching, Code of Federal Regulations, Communication Skills, Community and Social Services, Consulting, Corrective Action, Customer Support/Service, Establish Priorities, Federal Compliance Regulations, Federal Government, Federal Laws and Regulations, Financial Administration, Financial Analysis, Financial Management, Government Regulations, Grant Administration/Management, IRB/IEC (Institutional Review Board/Independent Ethics Committee), Informed Consent, Interpret Regulations, Leadership, Maintain Compliance, Medical Research, Office Management, Operational Improvement, Operational Strategy, Operations, Operations Management, Operations Processes, Operations Research, Organizational Development/Management, Performance Analysis, Problem Solving Skills, Process Improvement, Public Health, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Requirements Management, Research Administration, Resource Management, Startup, State Laws and Regulations, Strategic Planning, Training/Teaching, Trend Analysis, Willing to Travel
LOCATION
Galveston, TX
POSTED
12 days ago

JOB SUMMARY

Provides strategic, operational, and compliance leadership for research activities within an academic medical center, including human subjects and/or animals. Serves as a primary source of expertise, training, and education in matters relating to government regulation of internal and externally funded research to the UTMB research community on behalf of the research administration offices. This role ensures that research involving human participants and animals is conducted in accordance with federal regulations, institutional policies, accreditation standards, and ethical principles.

EDUCATION & EXPERIENCE

Minimum Qualifications:

  • Bachelor's degree or equivalent experience
  • Five years of experience in research administration
  • Strong knowledge of federal regulations governing academic medical center research.
  • Demonstrated leadership experience in a research, regulatory, or academic medical center environment.

Preferred Qualifications:

  • Master's degree in research administration, public health, regulatory affairs, or related field.
  • Certification such as CIP, CCRP, CRA or equivalent

ESSENTIAL JOB FUNCTIONS

  • Manages and monitors daily activities of research administration support staff, sponsored program specialists, clinical trial specialists, accountants, financial analysts, and supporting staff.
  • Advises staff in consulting with Principal Investigators and departmental administrators on fiscal responsibilities and project timelines.
  • Develop, implement, and refine operational processes that improve efficiency, consistency, and regulatory compliance.
  • Develop support services for Principal Investigator support to streamline research navigation.
  • May oversee financial management of all active accounts for clinical research, including accurate distribution of payments from sponsors, and review and authorization of expenses.
  • Acts as problem-solving resource for research administration support staff to ensure optimal service to research community and accurate compliance with federal, state, and institutional policies.
  • May oversee services that assist investigators with protocol development, grant administration, regulatory submissions, consent form preparation, and study start-up requirements
  • Analyze trends in noncompliance and audit findings to inform institutional training and policy updates.
  • May assist directors and other research administration departments in offering and coordinating training and education both internally and for the university community.
  • Evaluates the performance of research administration support staff and provides feedback and coaching regularly.
  • Manages time and attendance issues within office.
  • Ensure institutional compliance with Federal regulations (i.e., Code of Federal Regulations, Government Accountability Office, Office of Fede

ral Financial Management, and Office of Management and Budget), state laws, accreditation standards, and institutional policies.

  • Monitors workflow and assignment of duties and adjusts as needed for optimal productivity.

  • Coordinates cross departmental activities and determines appropriate communication channels to ensure alignment with research compliance offices (i.e., Human Research Protection Program, Institutional Review Board, Research Integrity, Clinical Trials Operations, Office of Sponsored Programs) and other research administration units.

  • May supports investigators through traveling to other campuses to promote cross-departmental coordination to maintain effective communication and alignment among the Human Research Protection Program, the Institutional Review Board, Office of Sponsored Programs, and other regulatory compliance units. Provide expert guidance on Federal regulations, institutional expectations, and b

est practices.

  • Benchmark national models and peer institutions to inform strategic improvements and organizational alignment.
  • Adheres to internal controls and reporting structure.
  • Performs related duties as required

KNOWLEDGE/SKILLS/ABILITIES

  • Comprehensive understanding of Federal regulations governing research (i.e., Code of Federal Regulations, Government Accountability Office, Office of Federal Financial Management, and Office of Management and Budget).
  • Awareness of institutional research structures academic medical center environments or clinical trials operations.
  • Advanced analytical skills for identifying compliance gaps, interpreting regulatory requirements, and evaluating audit findings.
  • Strong operational management skills, including workflow design, process optimization, and performance monitoring.
  • Skilled in stakeholder engagement and cross-departmental collaboration.
  • Proficiency in problem-solving and strategic planning within complex organizational structures.

LICENSES, REGISTRATIONS OR CERTIFICATIONS Required:

  • n/a Preferred: Certification such as CIP, CCRP, CRA or equivalent

SUPERVISION Received:

Dependent on Department -Director or other leader Given: Dependent on department -Research Regulatory Specialist, Clinical Study Monitor, Trials Coverage Analyst, Clinical Trial Information Specialist, Sr. Trials Coverage Analyst, Sr. Sponsor Program Analyst, Grants Administrator, Financial Analyst or Research Associates

DECISION-MAKING RESPONSIBILITY

Exercise independent authority over daily operations for staff in research administration and research support, including workload assignment, prioritization, and resource allocation. Makes independent compliance determinations and appropriate responses to actual or potential noncompliance concerns, including corrective actions, escalation, Manager or referrals by interpreting and applying federal and state regulations, accreditation standards, and institutional policies.

WORKING ENVIRONMENT/EQUIPMENT Standard office and equipment

Salary Range:

Commensurate with experience

Equal Employment Opportunity

UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.

Compensation

About the Company

U

University of Texas Medical Branch at Galveston