Position Summary

Under the direct supervision of the Clinical Coordinator at the Harlem Prevention Center, the Laboratory Manager is responsible for analyzing and processing specimens for all research conducted at the Harlem Prevention Center site and ensuring adherence to all applicable site protocols, procedures, policies, and relevant regulations. Works on protocols within the COVID-19 and HIV Prevention Trials Network as well as industry studies, and reports on progress to the Clinical Coordinator and/or the Site Coordinator.

Responsibilities

• Perform all Point of Care (POC) test as required per protocol including urine pregnancy tests, HIV rapid tests, rapid COVID test and urine dipstick collection; as well as processing, storage and shipping of blood samples along with other specimens as required by the study protocols. (10%)
• Assist with participant's study visits by performing phlebotomy and other specimen collection including nasal/ nasopharyngeal swab. (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. (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 the clinical quality management plan; and support and actively participate in continuous quality improvement activities. (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 up to date (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%)
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Minimum Qualifications

• Bachelor’s degree or an equivalent in education and experience plus three years of related experience
• Demonstrated experience organizing and implementing disparate workflows 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.
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Preferred Qualifications

• Bachelor’s degree in a laboratory science
• 3 years of experience working in a laboratory environment, and in clinical research studies.
• 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)
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Other Requirements

• Domestic travel, if needed