General Descriptionfull-time position with the Center for Immunization Research; 37. 5 hours per week; Monday - Friday; occasional weekends and evenings
Responsible for the coordination of all laboratory activities for the Center for Immunization Research's (CIR) Flavi Plus Team. These trials may be both in the inpatient and outpatient settings. Will be held solely accountable by Principal Investigator(s) for all laboratory functions at the sites.
Work as an integral member of the study team providing specialized skill and knowledge as it relates to laboratory procedures in the development and implementation of protocols for early phase clinical trials. Serve as primary liaison with the research laboratory personnel and all outside clinical laboratory contacts. Contribute to development of laboratory support plans for protocols implemented at the CIR. Prepare source documents for protocol implementation. Provide professional expertise in the creation and revision of laboratory Standard Operating Procedures (SOPs) and protocols. Monitor inventory of laboratory supplies, liquid nitrogen, and dry ice, and places orders as needed to ensure adequate amounts for the clinic.
Maintain and troubleshoot all laboratory equipment. Ensure compliance with CLIA, GCP, OSHA, and any other applicable regulatory body. Participate daily in the hands on work of the lab including, but not limited to, preparation of specimens for collection/processing, collecting and processing blood, urine, saliva, or other specimens according to study protocols (e.g. urinalysis, urine or serum pregnancy testing, phlebotomy, flash freezing, PBMC processing).
Responsible for accession of specimens for courier pick up. Maintain site shipping and storage logs of all specimens, including use of specified electronic system.
Conduct quality control checks of urinalysis dipsticks and Hcg testing kits. Conduct quality assurance checks on all laboratory reports and communicates with outside testing labs to resolve discrepancies.
Responsible for orientation and training of new and temporary laboratory personnel in general duties, protocol specific laboratory skills, and equipment usage.
Conduct screening and recruitment of study subjects as needed. Review and verify study reports. Maintain aseptic technique. Demonstrate organization, problem solving, resourcefulness and flexibility. Manage biohazard waste per JHMI policies. Attend training sessions for IRB updates, Human Subjects Protection, HIPAA, DOT/IATA, Blood borne pathogens, Fire Safety, Laboratory Safety, and other potential renewals as required by Sponsors/University.
Contribute to QA/QC process. Occasionally lifting, carrying, pushing, pulling objects weighing up to 50 lbs.
Perform other duties as required.