Lab Research Analyst 2

Be You.

The Duke Laboratory for HIV-1 & COVID-19 Vaccine Research & Development is led by Drs. David Montefiori, PhD and Xiaoying (Shaunna) Shen, DVM, PhD.  Our research focuses on neutralizing antibody responses, a key component of many successful vaccines for various infectious diseases.  We’re seeking qualified applicants to be part of this internationally recognized laboratory for providing standardized assessments of neutralizing antibody responses in preclinical and clinical HIV-1 and COVID-19 vaccine studies. This specific role will work in the Clinical Studies Operations Core.

Minimum Requirements:

• Work requires a bachelor's degree in botany, biology, zoology, psychology or other directly related scientific field.
• Work requires four years of research experience. A related master's degree may offset required years of experience on a 1:1 basis, e.g., a two year master's degree in lieu of two years of experience. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Preferred Qualifications:

• Bachelor’s degree in biological science or related field.
• Strong background in laboratory techniques including experience with cell culture, cell based neutralization assays and infectious materials including infectious influenza virus is a plus.
• Work requires four years of research experience. A related master's degree may offset required years of experience on a 1:1 basis, e.g., a two year master's degree in lieu of two years of experience, or equivalent combination of relevant education and research experience.
• Must be able to manage multiple and rapidly changing priorities and have the ability to quickly learn new skills.
• Must be detail-oriented and well organized with strong communication skills and the ability to work in a fast-paced interactive team environment.

Other Requirements:

This position is onsite. The work is performed on-site or at a designated assignment location.

Be Bold.

• Coordinate with Laboratory Study Managers on clinical study management lifecycle duties including development of cumulative specimen lists, tracking testing status, data quality control and documentation assembly, and data visualization. Contribute to QA documentation, corrective actions, and continuous improvement efforts by identifying nonconformances and recommending operational enhancements. Develop and refine data tracking tools and workflows to improve efficiency, accuracy, and audit readiness.
• Serve as laboratory’s lead technical and laboratory systems trainer for new hires and new processes for existing staff. Work with laboratory management and quality team to ensure compliance, documentation and best practices.
• Serve as lead laboratory staff for laboratory’s HIV and COVID-19 clinical testing programs including additional GCLP documentation, data quality control, assay tracking and reporting guidelines. Serve as subject matter expert for clinical testing. Serve as a lead assay representative for both internal and external audits of laboratory technical components.
• Provision of rapid assay qualification/validation experiment, special technical projects as needed and coordination across teams for deployment of updated processes and technologies.
• Co-direct clinical specimen management for Laboratory’s support of HIV and COVID-19 vaccine clinical trials. Coordinate with Laboratory Program Team and manage clinical specimen cumulative receipt and testing lists for assay planning and timeline development. Provide as training and support to other staff for clinical specimen access, database entry and resolution of issues. 
• Develop and implement process improvement projects specific to clinical study laboratory operations. Oversee application of new processes and workflows to ensure systems compliance, support enhanced lab operations, improve user interfaces, improve stakeholder communication and documentation, and ensure traceability and compliance.

• Assessment of neutralizing antibody responses in various cell lines in support of pre-clinical and clinical HIV-1 and COVID-19 vaccine development. Performance of more advanced research activities and projects. Conduct all experiments with complete adherence to Good Clinical Laboratory Practices (GCLP) guidelines.
• Data analysis with adherence to quality control pass/fail criteria. Report results in an accurate and timely manner to Laboratory Directors and Study Directors.  Review results for use in planning new experiments/analyses. Provision of rapid data quality control for other team members and Study Manager level assessments.
• Contribute to the daily laboratory effort to adhere to GCLP guidelines. Provide timely and critical review of SOPs as requested.  Adhere to all required safety, data integrity and policy protocols to protect staff, data integrity and others.

Choose Duke.

Join our award-winning team and be part of an inclusive culture that is committed to providing outstanding patient care, training tomorrow’s leaders, and conducting innovative research. You'll also benefit from Duke's competitive benefits package, including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.

Screening of Applications: Screening continues until the position is filled.