Duties: Oversees lab operations in the Infectious Disease Clinical Trials Processing Lab (IDCTPL), including daily supervision of biospecimen personnel and coordination of biospecimen collection, processing, storage and shipment. Work closely with Project Manager and clinical staff to develop the best processes which will ensure that study specimens are collected, processed and shipped in compliance with protocol requirements and timepoints. Develops and maintains collaborative relationships with outside instituations such as CHOP and Duke University and other departments such as the CTRC. Ensure the staff coordinates transport of samples from the clinic to the research laboratory. Ensure the staff processes and ships samples per protocol requirements. Supports the lab staff through performing any necessary lab related duty, such as specimen processing and shipment. Troubleshoot any biospecimen-related issues that may arise. Revise and develop SOPs to maximize lab efficiency, maintain protocol compliance, adherence to local, state and federal standards/regulations, while maintaining GCLP. Establishes and maintains procedures for the collection, tracking, storage, shipping and analysis of environmental and biological specimens in adherence with study design and protocol requirements, ensuring that the status of each specimen is known and tracked at all times. Oversight of lab equipment, including proper maintenance, inspections and calibration as needed and maintain requisite documentation of such. Implement an inventory control system to ensure efficient use of lab space and storage of kits, ensuring expired lab kits are identified and disposed, as well as that studies are properly stocked with necessary lab kits. Responsible for off-hours coverage of specimens in storage in the event of any concerns, such as freezer malfunction and to be the first point of contact.
Qualifications: A Bachelor's Degree in scientific discipline and 3 years to 5 years of experience or equivalent combination of education and experience required. Applicant must be detail oriented and able to work independently. Must possess ability to interact easily with clinical and research staff. Must possess superb time management skills; be very well organized and highly motivated. Ability to communicate clearly, work with varying personalities and manage multiple projects and duties. Knowledge of PC applications and experience in data entry is preferred. Physical requirements include frequent walking, bending, lifting of supplies and packages, and manual dexterity to select small vials from frozen storage locations
Reference Number: 40-25394
Salary Grade: 026
Employment Type: Exempt
Org: DM-Infectious Diseases
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: I-Technical/Professional Research