Supervisor, Clinical Immunology Lab

• Manage and allocate resources and staff to support biorepository activities;
• Ensure all personnel adhere to the SOPs and follow the biosafety procedures for handling biospecimens at a BSL2+ level;
• Oversee staffing and workflow to ensure efficient and accurate achievement of CIL goals;
• Develop, maintain, review, revise, or edit training manual(s), which can include SOPs;
• Oversee staff required credentials and renewals, including biosafety training, and Citi training (human Subjects) and Good Clinical Practices;
• Manage the Clinical Immunology Laboratory blood processing schedule;
• Interface with the Clinical Team for scheduling and updates on a study;
• Attend all study initiation meetings and regular CIL meetings.

• Assist the CIL Director in the maintenance/revision of a Quality Management Plan;
• Design, conduct, and schedule regular quality control tests/audits and reports;
• Oversee the development of new and the annual review of SOPs;
• Assist with the development and responsible for scheduling and documenting regular reviews of SOPs;
• Oversee performance of quality control checks and documentation regularly (24/7) to ensure that procedures are consistently followed;
• Respond to Corrective Action and Prevention (CAPA) reports;
• Assist in sending samples for the Immune Quality Assurance program for PBMC proficiency testing.

• Purchase and maintain adequate quantities of routinely used supplies to ensure operations can proceed with no or minimal disruption;
• Assist CIL Director with budget and purchase of capital equipment;
• Maintain document control by managing and organizing all project documents (reports, memos, audits, communications, etc.), ensuring their standardization, accuracy, quality, and integrity;
• Adhere to retention policies, safeguard information, and retrieve data more effectively;
• Create and update sample management tracking logs and forms;
• Recognize, document, and resolve protocol deviations;
• Create estimated budgets for CIL studies;
• Verify and authorize specimen requests.

• Maintain daily scheduling of processing activities in biorepository and clinical immunology laboratory for clinical trials;
• Process whole blood into PBMCs, plasma, and sera according to HANC SOP from ongoing vaccine clinical trials;
• Ensure Good Clinical Practice standards are met for samples processed in the biobank;
• Assist with routine tasks as necessary for vaccine clinical trials.

• Learn and use different Laboratories Information Management Systems (LIMS) such as Freezerworks, Global Trace, etc or any of those used by different sponsors.

• Processing, inventory, and cryopreservation of biomaterial in support of clinical trials, with an emphasis on GCP;
• Experience in inventory maintenance, and biobanking informatics, and their routine application to clinical trial operations: e.g., maintenance of the inventory, pulling samples, assembling shipments, and receiving shipments;
• Experience in cryopreservation methods, with a particular emphasis on the isolation and cryopreservation of PBMCs according to the HIV/AIDS Network Coordination (HANC) SOP for isolation and cryopreservation of Peripheral Blood Mononuclear Cell (PBMC) as well as for processing plasma and serum;
• Experience in informatics and sample tracking systems: e.g., Freezerworks [FW] and GlobalTrace [GT];
• Experience in writing SOPs and reading and understanding clinical trial protocols;
• Experience in shipping using cryoports or other LN2 shippers;
• Experience shipping according to IATA regulations;
• Experience in communicating verbally and electronically with CIL directors, CIL staff, clinical site staff, and protocols team members, which includes communicating with clinical investigators (e.g., physicians, physician assistants, nurses, and clinical coordinators);
• Competency in Laboratory Information Management System (LIMS) specifically Freezerworks, and GlobalTrace;
• Competency in working with the GWVRU clinical team to receive samples from clinical trials, process them, and either storing or shipping them as needed;
• Ability to read a clinical trial protocol and determine the responsibilities of the laboratory in support of the protocol, i.e., when will samples be received by the laboratory, when what to do with them and when to ship them or store them;
• Experience working work with industry sponsored vaccine clinical trials such for Pfizer, Moderna, or Immorna.

The university is an Equal Employment Opportunity/Affirmative Action employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law.