Durham, North Carolina

School of Medicine:

 

Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

 

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

Duties focus on systems management, validation, and compliance

 

Occupational Summary

 

The Center for Human Systems Immunology (CHSI) data and application management team is looking to fill a quality assurance role to aid in the delivery of compliant software, tools, and solutions that work to support global clinical, pre-clinical, and basic research studies surrounding vaccines development, immunology, and quantitative sciences.

 

The systems compliance specialist role is focused on systems and code review, providing testing and documentation to support verification of DAMT developer activities and laboratory information systems. The ideal candidate for this role has intermediate Python/R programming experience and is looking to move into a compliance/validation position or comes from a compliance/validation role with experience in code review.

 

Work Performed

· Under the direction of the DAMT program manager conduct risk assessments, validation plans, IQ/OQ/PQ, and release approval for various software and systems, working with quality assurance (QA) and research groups as needed.

· Review and test code developed by DAMT working group to ensure user and functional requirements are met.

· Conduct change control procedures to maintain compliance.

· Create, revise, and review standard operating procedures, policies, reports, and other process documentation surrounding systems, software, and data management.

· Act as liaison between DAMT program manager and research, data management, I.T., and vendor staff to facilitate communications between all parties for compliance activities.

· Support research groups during internal and external audits, providing information on procedures and responses to findings as needed.

· Learn DAMT processes and tools surrounding QC, processing, analysis, and reporting of data to better support and lead compliance efforts.

· Train research, data management, and I.T. staff on systems compliance practices. Assist with hosting workshops and information sessions on relevant topics. Cross-train team members on performed duties as needed.

 

Minimum Qualifications

 

Education:

Work requires an bachelor’s degree in a field related to information technology, computer science, OR a biology, informatics, or statistics degree with an equivalent combination of programming, systems and/or compliance work experience.

 

Experience:

· Intermediate competency with either R or Python programming languages required.

· Awareness of any relevant regulations (GxP, GCLP, 21 CFR Part 11), computer system validation practices, and software development life cycle is a plus.

· Knowledge of clinical research environments is a plus.

 

Required Minimum Qualifications

 

Education: 

Work requires a bachelor's degree.
 
Experience:  

  • Bachelor’s degree in a field related to information technology, computer science, OR a biology, informatics, or statistics degree with an equivalent combination of systems and/or compliance work experience. 
  • Work requires one to two years’ experience in a field related to systems validation, data management, C.S / I.T., OR clinical laboratory experience with an equivalent combination of relevant education in C.S., I.T., or systems validation. 
  • Awareness of any relevant regulations (GxP, GCLP, 21 CFR Part 11, GDPR, GAMP5), computer system validation practices, and software development life cycle is a plus. 
  • Knowledge of clinical research environments is a plus

 


 

 

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.

 

Durham, North Carolina

As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

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