United States of America: Laboratory Manager

Organization: International Center for AIDS Care and Treatment Programs

Country: United States of America

Closing date: 31 Aug 2015


Under the supervision of the Program Manager/CRS Coordinator, the Laboratory Manager will perform protocol defined procedures including rapid HIV test, phlebotomy, specimen processing, storage and tracking of specimen through LDMS (Laboratory Data Management System), and shipping of specimens to the Laboratory Center. Responsible for monitoring temperature readings in the lab room, specimen refrigerators, (-70) freezer and storage room for HIV test kits; maintaining an up-to-date laboratory CLIA waiver and other required lab certifications; and maintenance of lab equipment and supplies.


Please note that this position will be located at 215 West 125th Street, New York, NY 10025.


This position is grant funded.


Major Accountabilities:


  • Conduct all research activities in accordance with study protocol, standard operating procedures and other appropriate institutional regulations, procedures, and policies, including procedures to safeguard confidentiality of study participants.

  • Perform protocol defined procedures including but not limited to rapid HIV test, phlebotomy, specimen processing, storage and tracking of specimen through Laboratory Data Management System (LDMS), and shipping of specimens to Laboratory Center (LC).

  • Maintain laboratory supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.

  • Maintain laboratory equipment performance and arranging equipment replacement, service, and repair.

  • Monitor temperature readings in the lab room, 2-8 degree centigrade specimen refrigerator, (-70) freezer and storage room for HIV test kits.

  • Respond to alarm from the central monitoring device if there is a recorded out of range temperature reading of the (-70) specimen freezer and 2-8 degree centigrade refrigerator.

  • Maintain an up-to-date site laboratory Clinical Laboratory Improvement Amendments (CLIA) waiver and other protocol required CLIA and College of American Pathologists (CAP) certifications of external labs.

  • Prepare and update lab Standard Operating Procedures (SOPs) and coordination plans for external labs, and create tracking mechanisms in the custody of lab specimens.

  • Provide accurate and timely responses to data queries received from the Statistical and Data Management Center (SDMC) and LC in coordination with the site coordinator and data manager.

  • Coordinate with external labs for the processing and testing of protocol required specimens.

  • Perform quality assurance activities in collaboration with the data manager, the site coordinator, SDMC and LC.

  • Maintain accurate, comprehensive study records and source documentation.

  • Prepare research records for on-site external audits.

  • Attend study specific and other study related trainings and meetings as requested by the site coordinator.

  • Perform other duties as assigned.

Education


  • Requires a Bachelor"s degree in the sciences or related field, or equivalent in training and experience; plus three (3) years of directly related experience.

Experience, Skills & Minimum Required Qualifications:


  • Minimum two (2) – three (3) years of experience working in clinical research studies

  • Phlebotomy certification, training and demonstrated experience

  • Excellent organizational, interpersonal and communication skills and detail oriented

  • Must be able to adapt to flexible schedule

  • Proficiency in Microsoft computer applications (Word, Excel, PowerPoint etc.)

Experience, Skills & Preferred Qualifications:


  • LDMS training and certification from Frontier Science and Technology Research Foundation (FSTRF)

  • GCLP (Good Clinical Laboratory Practice for Processing Laboratories) training and certification

  • IATA certification for Dangerous Goods handling and transport

  • Experience in research involving human subjects, preferably with HIV/AIDS trials

  • An interest in/or experience with community health and or MSM and transgender"s health

  • Experience working with an ethnically, culturally and racially diverse environment


How to apply:

To apply, please click on link below (or copy and paste onto your web browser).


http://jobs.columbia.edu/applicants/Central?quickFind=149948


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