Laboratory Manager

Position Summary

The Bronx Prevention Center, part of ICAP at Columbia University, is a Clinical Research Site (CRS) within the NIH-funded AIDS Clinical Trials Unit at Columbia University. Located in a clinical office on East 158th Street in the Bronx, the site has over ten years of experience conducting phase 1 and 2 and observational HIV prevention clinical trials.
Under the direct supervision of the Site Clinician, the Laboratory Manager is responsible for analyzing and processing specimens for all research conducted at the Bronx Prevention Center site and ensuring adherence to all applicable site protocols, procedures, policies, and relevant regulations. Works on protocols within the Coronavirus and HIV Prevention Trials Network as well as Industry studies and reports on progress to the Site Clinician and/or the Site manager.

Responsibilities

• Perform all Point of Care Test per protocols including: urine pregnancy tests; HIV rapid tests; Rapid COVID test and Urine Dipstick Collection and storage of blood samples along with other specimens as required by the study protocols. (10%)
• Assist with patients’ study visits by performing HIV counseling and testing, phlebotomy; collect vital signs; EKG; collect Nasal/ Nasopharyngeal swab, medical and pelvic exams; interview patients and complete study documentation. (10%)
• Maintain confidentiality of study participants and adhere to principles of Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP) and International Air Transport Association (IATA) certification. (5%)
• Use Laboratory Data Management Systems (LDMS) to track specimens and assist with shipping specimens. Check laboratory room and freezer temperature at least twice a day. Maintain cleanliness of laboratory room. (5%)
• Maintain laboratory research files and document results of test performed in accordance with study protocols. (5%)
• Maintain and replenish laboratory inventory; keep records of inventory usage and order new laboratory supplies when needed. Set up medical examination rooms prior to exams and maintain cleanliness of examination rooms. (5%)
• Contribute to and participate in the Performance/Quality Improvement activities of the research site: perform data collection and analysis; implement and ensure compliance with risk management and claims activities; and support and actively participate in Continuous Quality Improvement (CQI). (10%)
• Ensure site compliance with study protocols, all relevant procedures, policies and regulations. Learn, understand and adhere to existing and new study protocols, Standard Operating Procedures and other appropriate regulations, procedures and policies. (10%)
• Ensure new Quest Account is set-up with each new study (5%)
• Ensure all equipment is up to date and calibrated annually (5%)
• Ensure that all temperatures are recorded for the research refrigerator and -70 freezer (5%)
• Train research staff on POC testing and keep training records UTD (5%)
• Ensure CLIA Waiver is current and complete the renewal application (5%)
• Assist with other study procedures, Quality Control Quality Assurance (QCQA) activities, and administrative tasks at the study site. (5%)
• Establish and maintain positive relationships and interacts professionally, courteously, and appropriately with participants and visitors to the research site and other employees working at the site. Behave in a manner consistent with maintaining and furthering a positive public perception of the research site and its employees. (5%)
• Perform other related tasks as assigned. (5%)

Minimum Qualifications

• Bachelor’s Degree or equivalent in education and experience plus three years of related experience
• Demonstrated experience organizing and implementing disparate work flows to meet organizational schedules and requirements.
• Excellent oral, written and interpersonal skills.
• Excellent phlebotomy skills.
• Experience with obtaining and processing laboratory specimens and running lab tests.

Preferred Qualifications

• Bachelor’s degree in a laboratory science
• 3 years of experience working in a laboratory environment.
• Minimum 3 years of experience working in clinical research studies.
• Minimum 1 year of experience conducting laboratory assays
• Bilingual (Spanish/English preferred).
• Experience with Peripheral Blood Mononuclear Cell (PBMC) processing.
• Certifications in Good Laboratory Practices (GLP), Human Subjects Protection (HSP), Good Clinical Practice (GLP) and International Air Transportation Association (IATAA).
• Familiarity with Laboratory Data Management System (LDMS)

Other Requirements

• There are no domestic or international travel requirements associated with this position