PROJECT PLANNER II

Duke Clinical Research Institute

United States, North Carolina, Durham

300 West Morgan Street (Show on map)

May 26, 2023

Duke University and Duke University Health System require all students, faculty and staff to receive the COVID-19 and influenza vaccines. After you have officially accepted a position at Duke, you may request a religious or medical accommodation.

PROJECT PLANNER II

Work Arrangement:

Requisition Number:

227119

Regular or Temporary:

Regular

Location:

Durham, NC, US, 27710

Personnel Area:

MEDICAL CENTER

Date:

Jun 14, 2023

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

OneDukeBio LIMS Administrator

Occupational Summary

The OneDukeBio Laboratory Information Management System (LIMS) Administrator provides support for all administrative functions involving the LIMS including system configuration, troubleshooting issues, user access, reporting, authoring standard operating procedures (SOPs), and ensuring regulatory compliance (21 CFR Part 11 and cGMP) in the LIMS business processes. The LIMS Administrator must understand database structure, auditing functions, report query configuration, as well as facilitate and support improvements to the business processes. The LIMS administrator is the primary contact with the LIMS vendor and responsible for managing the vendor relationship, including issue escalation, licensing, invoicing, and identification of future roadmap functionality. The LIMS administrator will create, manage, and drive all governance processes related to the LIMS, including stakeholder group membership, processes for onboarding/offboarding of biobanks, and evaluation and approval of system enhancements/changes.

Work Performed

As an integral member of the OneDukeBio LIMS implementation team, manage the deployment, set-up, configuration (creating workflows, analytical test methods, and analytical specifications), validation [Installation/Operational/Performance Qualifications (IQ/OQ/PQ)], validation plans, user requirements, risk assessments, using Good Manufacturing Practice (GMP) requirements, and execution of test scripts for the LIMS system.

Perform all duties as LIMS administrator, on-going configuration, and improvements, develop custom reports, troubleshooting, and maintenance in conjunction with Information Technology (IT) and the vendor
Collaborate with vendors on upgrades and improvements. Install and validate new software revisions as they are released. Partner with DUHS IT for troubleshooting.
Lead and coordinate technical issue investigations and manage technology resolution implementations
Actively manage change control by following procedures and work instructions, including internal Duke Health Technology Services (DHTS) processes
Partner with DHTS/Vendor with the validation of system improvements (drafting user requirements, PQ protocols, and execution of protocols)
Partner with Duke Crucible in the development and implementation of an integrated data repository and the process for linking LIMS data with other data about the specimens (e.g. consent, clinical data, derived results, stability testing, etc.)
Author and collaborate on SOPs, Deviations, Corrective and Preventive Actions (CAPAs) and Change Controls and policies for LIMS applications and end-users as necessary
Stay up to date on advances in the software and technology; provide appropriate training to new and current employees as needed. Keep LIMS application up to date (new product versions, new modules, new module versions).
Work with site leaders and study teams to identify, capture, update and maintain master data
Serve as a technical expert to assist and provide support to end users for LIMS application
- Understand and resolve user requests
- Troubleshoot any unexpected errors which arise
- Support end-user LIMS template and data entry issues
- Process access requests
- Verify and report system and product errors to LIMs vendor support
Provide Regular reports regarding system status and updates

REPORTING RELATIONSHIP: The OneDukeBio LIMS Administrator will report to the Director for OneDukeBio Clinical Research Education Training & Operations.

Required Qualifications at this Level

Education/Training:	Work requires completion of a Bachelor's degree. A Master's degree is preferred, but not required.

Experience:	Work requires a minimum of four years of research experience, with ten (10) years directly relevant experience with biobanking preferred. A Master's degree may substitute for two years of related experience. Experience working in or with biobanking, research and/or information technology teams is a must.

Skills:	Strong evidence of success as a leader and communicator. Excellent verbal, written, and analytical skills. Collaborative and solution oriented. Able to work independently and in a team setting. Proficient in quantitative and qualitative analysis and data-driven decision-making. Ability to work with a wide variety of stakeholders including research faculty, contracting professionals, legal counsel, sponsored program and research compliance professionals and senior leadership of the University A thorough understanding of federal and other external requirements associated with data security and compliance.

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Nearest Major Market: Durham

Nearest Secondary Market: Raleigh