39159BRExtended Job Title:Sr Rsch Compliance SpecialistOrg Level 1:Texas Tech Unv Hlth Sci Ctr El PasoPosition Description:Performs routine compliance activities related to research compliance, including human subjects, animal care, conflict of interest and/or export control. This position is reserved for use in departments that have institutional oversight of research.Requisition ID:39159BRTravel Required:Up to 25%Major/Essential Functions:
Conducts audits of non-exempt, and expedited protocols approved and/or acknowledge by the TTUHSC El Paso IRB to ensure compliance of human subject research trials.
Develop and complete audit checklist reports after each audit based on the Corrective Action Matrix found on the Research Compliance Manual.
Report and audit findings to the study team and to designated research personnel; follows-up with research teams to ensure that all corrective actions are completed on a timely basis.
Enter audits, findings and corrective actions onto the SharePoint Corrective Action Tracker system and update completed corrective action for each audit record as they are completed.
Work with the investigator and study team to identify root causes for identified areas of non-compliance.
Assess and investigate reports of non-compliance related to research. Relay findings to pertinent stakeholders and institutional officials.
Review unanticipated events and sponsored monitoring reports submitted by research teams. Monitor for potential need to audit and take appropriate actions if increased risk is identified.
Develop a quarterly audit plan to determine protocols to audit based on identified risk areas and/or operational requests.
Maintains institutional ClinicalTrials.gov system by serving as the main administrator for the institutional page and by updating and maintaining internal guides and resources related to this system.
Serve as the main system institutional resource for guidance on clinical trials registration requirements and communicates with researchers to ensure compliance with ClinicalTrials.gov reporting requirements.
Review the "Outstanding Effort Certifications by Coordinator by Division 2" report on a quarterly basis before the end of each certification period to check for effort statements that have not been certified and/or processed.
Assist effort Coordinators, PIs and Certifiers with the certification process by monitoring the certification process to ensure all effort statements are certified and processed according to the established timelines.
Initiate and impose the escalation of non-compliance in accordance with HSCEP OP 65.07 when effort submission compliance is not adhered to. Report outstanding effort statements to VPR in preparation for Escalation of the Non-compliance process.
Chair and oversee the Research Compliance Committee operations including meetings, minutes, follow up of action items and responding to inquiries.
Provide research export control oversight, including the development of training, education and assessment tools, and the implementation of policies and procedures to promote the Institution’s ongoing compliance with export control laws.
Provide support in development and updating of internal policies, SOP’s, and user guides intended to yield institution-wide compliance with the research compliance program.
Assist investigators and research personnel on system-related questions as they relate to Research Compliance.
Develop, implement and evaluate educational/training materials, workshops and programs aimed at enhancing the TTUHSC EP human research protection program.
Updates and maintains the Research Compliance website to ensure accuracy.
Participates in the preparation for external audits by regulatory agencies or sponsors.
Assist with other duties as assigned by the Senior Director for the Office of Research.
Adhere to all TTUHSC EP policies and procedures and processes.
Personally demonstrate, display and act in accordance with TTUHSCEP’s values (Service, Respect, Accountability, Integrity, Advancement and Teamwork). Actively promote and encourage staff across the institution.
Grant Funded?:NoMinimum Hire Rate:Compensation is commensurate upon the qualifications of the individual selectedPay Basis:MonthlyWork Location:El PasoPreferred Qualifications:
Requires working knowledge of Microsoft Office.
Knowledge of iMedRIS. Working knowledge of video editing software (e.g. Movie Maker, VideoStudio, or Final Cut Pro).
Expertise in publishing software (Publisher, Page Maker). One year of clinical research experience.
Campus:HSC - El PasoDepartment:Research Administration and FinanceRequired Attachments:Cover Letter, Resume / CV, TranscriptJob Type:Full TimePay Statement:Compensation is commensurate upon the qualifications of the individual selected and budgetary guidelines of the hiring department, as well as the institutional pay plan. For additional information, please reference the institutional pay plan website (https://app4.ttuhsc.edu/payplan/) .Job Group:First Line Other AdmnShift:DayEEO Statement:All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, disability, genetic information or status as a protected veteran.Required Qualifications:
Bachelor's degree in job related field plus three years of related experience; OR
A combination of related education and or experience equal to seven years.
Does this position work in a research laboratory?:NoJeanne Clery Act:The Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act is a federal statute requiring colleges and universities participating in federal financial aid programs to maintain and disclose campus crime statistics and security information. By October 1 of each year, institutions must publish and distribute their Annual Campus Security Policy & Crime Statistics Report (ASR) to current and prospective students and employees. To view this report, visit the TTUHSC Clery Act website (https://www.ttuhsc.edu/emergency/clery-report.aspx) .
