Research Data Integrity Specialist

Texas Biomedical Research Institute•San Antonio, TX

1d•Onsite

About The Position

This Research Data Integrity Specialist position is responsible for generating, maintaining, and overseeing study summary data tables and Standard for Exchange of Nonclinical Data (SEND) datasets, as well as coordinating and preparing data archiving activities for Applied Science & Innovation (ASI)-regulated studies.

Requirements

Bachelor’s degree from an accredited college or university (required)
Strong written and verbal communication skills and ability to work effectively in a diverse, collaborative environment
Experience creating and maintaining databases, study summary tables, and SEND datasets
Strong organizational and time management skills with the ability to prioritize competing deadlines
Proficiency in Microsoft Office (Word, Excel, Outlook) and Adobe Acrobat
Knowledge of laboratory safety practices and procedures
Highly organized, detail-oriented, and committed to accuracy, quality, and compliance
Strong technical aptitude with data systems and related tools
Demonstrated ability to work independently while contributing effectively in a team environment, maintaining high productivity and professionalism

Nice To Haves

Minimum of two years of relevant experience, with knowledge of regulatory requirements governing regulated studies (preferred)

Responsibilities

Generate, update, track, and maintain study summary data tables for ASI-regulated studies
Generate, validate, and maintain SEND datasets in compliance with FDA requirements for regulatory submissions
Apply quality control standards and sound judgment to ensure accuracy, completeness, and data integrity
Review, investigate, and resolve data queries, implementing appropriate corrections or modifications as needed
Collaborate closely with Principal Investigators, Study Directors, and the Project Management Office to ensure timely project delivery
Oversee final study archiving activities, including determination and submission of study notebooks to the Institute GLP Archive
Coordinate submission of pathology slides to the Pathology Archive
Provide technical support for data management of legacy studies
Ensure all data management activities comply with SOPs, study protocols, and regulatory requirements
Prioritize and manage multiple tasks in a fast-paced environment with shifting deadlines
Participate in cross-functional team meetings and data review discussions
Support ASI and Internal Process Quality Control (IPQC) initiatives as needed

Benefits

Comprehensive health, dental, vision, and life insurance coverage for you and your family—including pet insurance options.
Competitive employer-funded retirement plan with 6% contributions starting on day one, increasing with years of service.
Generous paid time off, including 14 paid holidays and a paid Winter Recess (from the last week of December through New Year’s).
Paid time off for short-term illness and mental wellness, helping you take the time you need when life happens.
Volunteer Time Off (VTO) to encourage giving back to the community.
Paid parental leave to support you and your growing family.
Flexible work arrangements that support a strong work-life balance.
On-site medical clinic, wellness incentives, and prescription support programs designed to make care more accessible and affordable.
On-site fitness center and wellness programs to help you stay active and healthy.
Relaxed dress code so you can feel comfortable and be yourself at work.
Dynamic learning environment with professional development opportunities, mentorship, tuition reimbursement, and leadership programs to support your growth.