Research Data Integrity Specialist at Texas Biomedical Research Institute

San Antonio, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Aug, 26

Salary

0.0

Posted On

22 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

SEND Datasets, Data Integrity, Quality Control, Regulatory Compliance, Data Archiving, Microsoft Office, Adobe Acrobat, Database Management, Technical Writing, Time Management, Collaboration, Laboratory Safety

Industry

Research Services

Description

Description 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. THE ROLE: 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 OUR IDEAL CANDIDATE: Bachelor’s degree from an accredited college or university (required) Minimum of two years of relevant experience, with knowledge of regulatory requirements governing regulated studies (preferred) 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 WHAT WE CAN OFFER YOU: Enjoy an employee-centered culture grounded in open communication, empowerment, and trust. We believe in working hard and having fun, offering 100+ culture events each year to bring our team together and keep the energy strong! 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. Proud recipient of the 2025 Healthy Workplace Platinum Recognition from the San Antonio Business Group on Health (SABGH)—the highest honor for employee-focused wellness initiatives. WHO WE ARE: Texas Biomedical Research Institute is one of the world's leading independent biomedical research institutions dedicated to advancing global human health through innovative biomedical research. Texas Biomed aims to unravel the mysteries of infectious diseases through innovative thinking, creative problem solving and cutting-edge technologies. Texas Biomed is the only independent, nonprofit infectious disease research institute in the U.S. to combine: The highest-level biocontainment labs for infectious disease and biodefense research A federally-designated National Primate Research Center More than 80 years of discoveries advancing diagnostics, vaccines and therapies An entrepreneurial culture and specialized expertise in regulated science required for FDA approval We take pride in fostering a culture of respect, opportunity, and unity! Texas Biomedical Research Institute provides equal employment opportunities for all qualified employees and applicants without regard to race, color, sex, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Responsibilities

Responsible for generating and maintaining study summary data tables and SEND datasets in compliance with FDA requirements. The role also involves overseeing data archiving activities and collaborating with investigators to ensure timely project delivery.