Supervises activities of the clinical lab specimen intake team, clinical research lab and biorepository by overseeing and guiding technologists, ensuring lab compliance with all associated rules and regulations to ensure continued ASHI, CLIA & CAP accreditation, and managing clinical research projects from the laboratory perspective. Manages operations and projects, including validating of new lab supporting software and procedures. Reviews and signs off biorepository instrument and reagent quality control documentation per lab policy. Maintains detailed records of Laboratory Quality Control and Quality Assurance activities, which may include collecting, extracting, trending and entering data. Supervises laboratory workflow and evaluates technologists’ performance and competency as required by Northwestern University Transplant Immunology laboratory and the aforementioned accreditation agencies.

Please note: This position may include some on on-call work on weekends.

Please note: May need to support on-call work on weekends.

Employee will require access to NM/Northwestern Memorial Hospital and Lurie Children’s Hospital.

Employee affiliation to NM requires COVID-19 vaccination and yearly influenza vaccination documentation submission or proof of accommodation/ religious/medical exemption.

Specific Responsibilities:

• Oversees the receipt of biospecimens and ordering of clinical histocompatibility testing. Assists technologists in resolving issues with sample or order discrepancies.
• Optimizes protocols and coordinates multiple complex projects, prioritizing the clinical specimen workflow.
• Completes all aspects of the standard procedures performed in the ASHI, CLIA and CAP accredited laboratory.
• Maintains and ensures quality of laboratory instrumentation and reagents,
• including extensive documentation of scheduled maintenance.
• Manages specimen intake section, clinical research lab, and biorepository data and generates reports as needed.
• Coordinates clinical lab specimen intake and clinical research study sample processing.
• Orchestrates the retrieval of and send out of clinical samples domestically and internationally through the referred testing laboratory at Northwestern Memorial Hospital.
• Orchestrates the retrieval of and send out of research samples domestically and internationally from the Clinical Research Laboratory/Biorepository using approved couriers.
• Maintains organized, detailed documentation of each sample processed, Stored or sent out from the
• Collaborates with technologists to oversee the operations of the quality assurance committee, ensuring quality reports and data trends are up to date. Follows up on successful implementation and outcomes from quality-driven corrective actions.
• Manages clinical lab and biorepository inventory and quality assurance software and executes necessary actions in collaboration with the lab leads, supervisors, managers, directors or designees.
• Leads development and implementation of accreditation inspection preparation activities.
• Assigns and completes daily general lab maintenance, as needed.
• Recognizes areas to improve laboratory service to the clinical and research programs.
• Enhances support for various clinical studies through implementing more efficient and productive courses of action for sample processing.
• Observes and alerts study and lab managers to key areas where communication
• breakdown, loss of sample integrity, or potential processing problems may arise.
• An expert level in many of the stated skills below is required
  • Molecular Biology:
    • NA, RNA isolation
  • Cellular Biology:
    • Cell culture, cell isolation
  • Histology:
    • Microscopy
  • Other (please specify):
    • Aseptic Technique
    • Cryopreservation of Biological Samples

Administration

• Communicates with the transplant programs, lab staff and governmental agency (UNOS) to clarify and confirm testing orders in support of clinical workflow, as needed.
• Maintains detailed records of Laboratory Quality Control and Quality Assurance activities which may include collecting, extracting, trending and entering data. Interprets and/or presents results.
• Reviews and revises protocols as necessary to ensure that operating procedure objectives are attained.
• Participates in continuing educational activities.
• Additional responsibilities may be assigned in case of absence of other supervisors or manager to help ensure fluidity of workflow.

Finance

• Tracks and summarizes lab supply expenses.
• Verifies accuracy of invoices.
• Orders and/or maintains inventory of reagent, and/or lab supplies.
• Obtains sales quotes for lab equipment and supplies.
• Oversees repair and maintenance of all specific lab equipment.
• Ensures that lab supplies are ready and available when necessary.

Supervision

• Oversees and guides other technologists within the specimen intake and clinical research laboratory/biorepository. Ensures employees are up to date on training, continuing education, and laboratory performance demonstrating good judgment, conscientiousness, precision and accuracy.
• Trains other technologists or staff.
• Participates in competency observation of other technologists.
• Evaluates performance and conducts the annual performance review discussions with the subordinates

Miscellaneous

• Performs other duties as assigned.

Minimum Qualifications:

• Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a scientific major or related; OR appropriate combination of education and experience and 8 years' lab/bench or other relevant experience required; OR
• Successful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a scientific major or related; OR appropriate combination of education and experience and 6 years' lab/bench or other relevant experience.
• At least 2 years of supervisory or project management experience required.
• Has experience with maintaining accreditation with CAP, ASHI, or similar agency.

Minimum Competencies: (Skills, knowledge, and abilities.)

• Demonstrates sense of ownership and leadership; focused on goal and accomplishments, good communication skills, ability to work with full spectrum of colleagues, vendors, etc.
• Understands and is able to teach the fundamentals of good laboratory practice that ensure the viability and integrity of biological specimens for both clinical testing and research use.

Preferred Qualifications:

• Experience with standard clinical research laboratory operating procedures and workflows.
• Experience in training new technologists.

Preferred Competencies: (Skills, knowledge, and abilities)

• Experience with Histotrac or similar laboratory information management system.
• Experience with FreezerPro or similar laboratory freezer inventory management system; has some experiencing managing samples in a biorepository.
• Experience with MediaLab or similar clinical lab management software.

Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life’s challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you’re interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

Northwestern strongly recommends COVID-19 vaccinations and boosters for people who can obtain them as a critical tool for minimizing severe illness. More information can be found on the COVID-19 and Campus Updates webpage.

The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.