Research Regulatory Specialist, Institute for Translational Science
Min Qualifications:
Bachelor’s degree and five years of demonstrated success and experience in related or equivalent field and effective written communication skills. Outstanding documentation and attention detail. Must possess excellent interpersonal skills as well as effective verbal and written communication skills. Must possess leadership skills and have the ability to relate to a diverse group. Must demonstrate initiative, diplomacy, tact and professional demeanor.
Specific Job Related Duties:
- Provide analytical, technical and professional regulatory support to the research community.
- Support all aspects of regulatory compliance including but not limited to Institutional Review Board (IRB) processing and approval, IND/IDE submission and management, and Clinicaltrials.gov listing and reporting.
- Ensure optimal service to research community and accurate compliance with federal, state, and institutional policies
- Serve as a regulatory expert regarding compliance with the code of federal regulations regarding human subject research and drug/device development. Knowledge of regulations pertaining to the conduct of research.
- Perform structured and creative analysis of current processes to identify opportunities to enhance efficiency and effectiveness.
- Provide subject matter expertise in all systems utilized for processing the regulated data. Provide subject matter expertise to Information Technology in support of business objectives and initiatives, especially as it relates to interfacing and supporting the regulatory data.
- Identify, develop, and analyze metrics to measure the performance of processes.
- Identify procedural deficiencies, recommend, and implement solutions.
- Mentor and train new faculty and staff as needed on human subject protection, ethical principles, and regulated functions.
- Monitor regulatory changes and guidance and participate in ongoing educational activities to keep abreast of current issues relating to human subject research and drug/device development.
- Development and implementation of standard operating procedures and institutional policies and procedures.
- Collaborate with other institutional departments regarding development and implementation of AAHRPP elements and drug/device development processes.
- Conducts administrative duties as assigned within the office.
- Provides assistance with developing and managing budget.
- Review and improve UL1 and KL2 related administrative interactions with and submissions of other documents to NCATS.
- Oversee the process for the grantee institution.
- Obtain training from NCATS and other CTSA Consortium members and train others at the institution.
- Interact with a QA/QC group (to be created); attend quarterly virtual meetings; participate in a virtual QA/QC Discussion Form.
- Propose improvements/innovations.
- Other duties as assigned.
- Adheres to internal controls and reporting structure.
Salary Range:
Commensurate with experience, position grant funded
Preferred Work Experience:
Familiarity with Quality Assurance and Quality Control (QA/QC) and Project Management concepts; Human Subjects Research Regulations; and Institutional processes. QA/QC is the combination of quality assurance, the process or set of processes of ensuring products and services meet consumer expectations. Outstanding documentation and attention detail.
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 VEVRAA Federal Contractor, UTMB Health takes affirmative action to hire and advance women, minorities, protected veterans and individuals with disabilities
