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.

Job Description:

Function as analytical specialist for clinical research unit laboratory. Perform a variety of routine and moderately complex technical tasks in the performance of laboratory tests and handling of study specimens for storage and shipment. Oversee technical aspects of laboratory assuring that tasks are performed according to written procedures and policies with careful monitoring of quality control and quality assurance practices.

Primary Responsibilities:

Function as analytical specialist for DCRU laboratory services. Matter expert on instrumentation, testing, and QA/QC a. Assess study protocol and method of procedures for sample handling. b. Train lab staff on techniques outside of the current scope of service c. Monitor ongoing protocol compliance throughout the conduct of the study. d. Assess opportunities for improvement and work with peer level management to implement. e. Document quality control and quality assurance results. Resolve any non-compliance issues with peer level manger.

Develop/design/maintain robust systems to support lab function to include specimen inventory and tracking program 1. Explore programs to support sample custody tracking needs. 2. Implement program; oversee training, validation, and implementation. 3. Troubleshoot program as needed and work with vendor for appropriate system updates. 4. Routinely check on appropriate system usage.

Investigate and implement both CLIA waived and moderate complexity testing as it supports DCRU leadership incentives a. Explore options for a laboratory model that includes screening and safety testing in the DCRU. b. Participate in onboarding of laboratory testing c. Work with the medical director to assure regulatory activities related to laboratory testing are in place. d. Train existing and new staff members as necessary.

Update and oversee laboratory quality program within the context of the DCRI/DCRU parameters as well as national laboratory regulatory agencies a. Review written procedures and policies for accuracy and submit changes to manager or designee. b. Prepare for laboratory inspections. Review lab inspection documents and procedures to maintain knowledge. Bring any non-compliance issues to the attention of manager or designee.

Manage laboratory equipment and maintenance schedule and all related documentation a. Coordinate calibration and maintenance of equipment. b. Oversee daily and weekly instrumentation maintenance documentation.

Responsible for all training for DCRU staff a. Train new staff. Serve as a resource person/role model, as per guidelines determined by management. b. Provide technical guidance and instruction to interns, residents, staff and other employees.

Other Duties: Process and ship study samples per study specific protocol instructions Perform other related duties incidental to the work described herein.

Required Education/Training:

Work requires a bachelor's degree in Medical Technology or related field. Certification as a Medical Technologist by a nationally recognized board/agency is also required.

Required Experience:

Work requires 2 years of laboratory experience as a certified Medical Technologist.

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE.

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.

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