Research Support - Laboratory/Non-Laboratory, Staff/Administrative
This role functions as the product subject matter expert for the enterprise-wide (IU School of Medicine, Indiana Clinical and Translational Sciences Institute (CTSI), and Research Affiliates including medical centers) biospecimen management (BSM) module of the clinical trials management software system, OnCore. The role will communicate and engage with OnCore users, technical support personnel, the OnCore Manager, and Forte Research Systems, Inc., the software vendor of OnCore, regarding support, testing, training, documentation, and enhancements to BSM. The Laboratory Application Administrator will drive collaborations between departments, groups, and study teams to increase efficiency and productivity, and improve work-flow processes based upon the use of OnCore BSM in support of sponsor, consumer group, and investigator initiated clinical trials where specimens are collected. This position will be the primary individual for user support and OnCore BSM administration and will assist in the testing of software patches and enhancements as work closely with the OnCore support team in preparation and delivery of appropriate training and documentation to the user base of OnCore BSM. They will also setup Bartender label templates and work closely with laboratory staff to implement barcoded specimen tracking. Data reports will also be created and ran to ensure data integrity and accuracy of the various laboratories. As future laboratory applications are brought into production, such as electronic lab notebooks and quality management systems, the Laboratory Application Administrator would administrate, test, and train end users in the same fashion as OnCore BSM.
Duties and Responsibilities Include:
Biospecimen Management Application Support:
Serve as an escalation point and expert on OnCore BSM and biospecimen management.
Monitor support tickets in collaboration with the CTMS support team and assist with tracking identified issues, their priorities and resolution related to OnCore BSM.
Respond to inquiries of ranging complexity from faculty and staff regarding biospecimen tracking within OnCore BSM.
Provide consultation services to aid the development and initiation of new biospecimen protocol builds in OnCore BSM.
Provide assistance to users during the initial protocol setup process, and continue to provide support throughout the course of conducting the study as it relates to tracking biospecimen collections.
Collaborate with operations and support personnel to ensure effective communication and documentation of standards and best practices for system data.
Design Bartender label templates and implement barcoded specimen labels within the laboratories.
Analyze and test ongoing OnCore BSM upgrades and maintenance releases. Evaluate and document impact to current standardized minimum requirements. Articulate and communicate necessary changes with research enterprise staff, CTMS management and support.
Administrate additional required laboratory applications as they're deployed within the university.
Application Training and Education:
Understand laboratory workflows and related OnCore BSM training to individual laboratory needs.
Provide training for research staff on the Biospecimen Management (BSM) module of the clinical trials software system utilized by the Indiana University and its research affiliates to track research activities. Areas of focus will include protocol, biospecimen collection configuration, case, and specimen related data.
Schedule and conduct ongoing group OnCore BSM training sessions geared toward new users.
Provide ongoing instructional guidance, training and support for various levels of research personnel.
Address user questions around standard data entry guidelines and workflows related to the information relayed in the educational sessions.
Design and develop materials and training programs for education biospecimen management areas within OnCore BSM as well as additional laboratory applications.
Update and maintain training programs, materials, and documentation based on new functionality and evolving university standards, guidelines, and policies for use of OnCore BSM and additional laboratory applications.
Establish, oversee, and maintain various vehicles of communication and awareness such as CTMS website information, presentations, program materials, announcements, and emails.
Data Quality Review and Assurance:
Support investigators and study teams in the development and implementation of data quality assurance techniques for data elements used Enterprise-wide.
Review and monitor required data elements ensuring adherence to standard definitions and CTMS/BSM requirements.
Track and monitor data quality to help inform areas requiring further training or process improvement.
Work with CTMS management and support team to create processes to prevent data entry error and offer corrective action.
Assist CTMS management to enforce data entry requirements.
Bachelor's degree in science or health-related field and three years of related technical & laboratory experience.
Strong organizational, communication and documentation skills. Experience using a laboratory information management system or biospecimen tracking system. Ability to maintain calm and composure in light of a multitude of tasks and deadlines. Willing to learn laboratory workflows and best practices in order to relate OnCore BSM to the user's laboratory responsibilities. Ability to effectively communicate and exchange information.
SQL experience and basic knowledge of relational databases.
Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.