Research Regulatory Specialist, Institute Translational Science; Hybrid

Position: Research Regulatory Specialist, Institute for Translational Science (Hybrid)
EDUCATION & EXPERIENCE

Minimum Qualifications:

Bachelor’s Degree or equivalent and 5 years of related experience

Preferred Qualifications:

Two (2) years of clinical monitoring experience or Three (3) years’ experience in developing training programs

Clinical Research Associate (CRA) Certification Understands and can apply knowledge of clinical trial designs to trial execution

Experience in the medical/healthcare industry

Job Description Provides regulatory expertise to faculty members, principal investigators, and research personnel in ensuring clinical processes are conducted in accordance with good clinical practice (GCP), IRB policies and procedures, sponsor and UTMB policy and guidelines. Responsible for identifying and escalating protocol deviations, noncompliance, and data discrepancies in order to ensure compliance with the study protocols and all applicable regulatory frameworks.

Under the direction of the Director of Research Integrity and Regulatory Affairs, the Quality Assurance Specialist performs and manages their portfolio. Assists in the development, implementation and maintenance of regulatory policies and the delivery of timely service to customers.

Scope:
This position interacts with organizational units spanning Research Regulations and Compliance (RRC), Research Administration (RA), school and departments, central UTMB administration, University of Texas System, State and Federal agencies, and accrediting organizations

Essential Job Functions Provide analytical, technical, and professional support to the Office of Research Integrity and Regulatory Affairs. (RIRA).Support all aspects of regulatory compliance including but not limited to Institutional Review Board (IRB) processing and approval, IND/IDE submission and management, and Clinical trials.gov listing and reporting

Serve as a regulatory expert regarding compliance with GCP and the Code of Federal Regulations regarding clinical research and other pertinent regulations

Provide analysis of study processes to identify opportunities to enhance compliance, efficiency, and effectiveness.

Troubleshoot clinical trials and activities.

Manage and maintain databases (quality systems and or trainings).May serve as subject matter expertise to Information Technology in support of business objectives and initiatives, especially as it relates to interfacing and supporting the regulatory data.

Prepare and assist in preparing annual reports and quality trending reports.

Report the status of the quality levels of staff, systems and production activities.

Preside over improvement programs.

Evaluate quality events, incidents, queries, and complaints.

Development and implementation of standard operating procedures and institutional policies and procedures.

Monitor regulatory changes and remain current on quality standards, all related legislation and compliance issues

Compile and prepare materials for submission to regulatory agencies.

Ensure regulatory rules are communicated through corporate policies and procedures

May create training and education programs in support of the objectives of RIRA and work with faculty and staff to create relevant education programs.

Ensure that investigator, vendor, facility and system audits are conducted.

Communicate any critical compliance risks noted from these activities to senior management.

Assume a lead role for the preparation, conduct, and responses to regulatory agency.

Adheres to internal controls and reporting structure.

Performs related duties as required.

Knowledge/Skills/Abilities Assist the individual in successfully performing the role Possess understanding of research regulatory requirements including GCP.Applied understanding of any applicable regulations (e.g., Good Clinical Practice, FDA CFR, clinical research ethics, HIPAA, and patient privacy laws).Competencies and essential skills in the following: cross functional relationships, decision making, execution/ results/ process improvement, customer satisfaction.

Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands. High attention to detail and accuracy.

Experience understanding technical, scientific, and medical information.

Able to foster collaborative and constructive relationships with colleagues, faculty, and management of the university.

A team player who works effectively in a complex, matrix organization.

Exceptional organizational skills and a focus on results that ensures timely progress on…