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The incumbent is responsible for coordinating study activities at the Specimen Processing Laboratory and BioRepository (SPL/BioR) in collaboration with Laboratory Leadership and Technical staff. The Study Coordinator/Data Analyst will oversee the day-to-day administrative requirements for supporting IRB approved clinical trials and their implementation within the SPL/BioR. This includes reviewing and maintaining protocol documents and preparing study analytical plans to facilitate implementation of required specimen processing, archival storage and distribution of clinical specimens used in diagnostic and clinical evaluation for clinical trials and other research activities conducted by the US Military HIV Research Program (MHRP), and the Infectious Disease Clinical Research Program (IDCRP). The incumbent must ensure compliance with all relevant regulations (CAP/CLIA/CLIP and FDA) pertaining to pre-analytical testing to assure specimen integrity. The incumbent is also responsible for managing the BioRepository database providing data reports in SPL/BioR management meetings.
- Reports to the Laboratory Director.
- Manages and receives shipments and oversees sample inventory and documentation in accordance with the laboratory procedures and relevant guidelines.
- Participates in Clinical Protocol Development meetings or calls and supports the Laboratory Director to project the workload requirements to ensure the laboratory is adequately staffed and trained.
- Oversees all specimen receiving, shipping, and relevant data entry for clinical trials supported by the SPL/BioR.
- Serves as the Data Analyst for the SPL/BioR entering data into and reporting data from Freezerworks (FW), used for specimen management and maintaining the BioRepository inventory. Develops protocol templates in FW, manages the FW database, and performs system upgrades in collaboration with the manufacturer as needed.
- Reviews study protocols and related documents (e.g. Manual of Operations, Laboratory Manual) and develops a Study Analytical Plan that outlines the protocol requirements regarding its implementation into the SPL/BioR.
- Prepares weekly schedule of specimens to be processed for each protocol. Interacting with clinical trial sites to update information needed to complete the weekly schedule.
- Maintains all protocol documents and supporting documentation to include but not limited to protocol amendments, material transfer agreements, laboratory manuals, manual of operations and email communications as required by the clinical trial sponsor, WRAIR and applicable regulatory agencies.
- Reviews and updates all Standard Operating Procedures (SOPs), or other relevant documents and works closely with the Laboratory Leadership and Technical Staff in the implementation of any new procedures in support of the clinical and research programs.
- Serves as the liaison between the clinical trial sites and the Laboratory, working with Clinical Site Coordinators and Principal Investigators to address protocol implementation, protocol deviations, and overall progress of protocol conduct within the Laboratory and BioRepository. Provides regular and timely updates to the Laboratory Director of any issues/concerns.
- Participates on protocol calls and provides updates regarding SPL/BioR protocol support to call participants as needed. Summarizes decisions and action items relevant to the SPL/BioR and provides summaries to the Laboratory Director, Laboratory Manager and Program Coordinator.
- Establishes and maintains all laboratory metrics for accuracy and efficiency within the Repository Operation. Works with the Laboratory Director to generate metrics and graphs for the annual report.
- Member of SPL/BioR Management Group and provides updates to other members on status of upcoming protocols, any protocol deviations, customer service complaints, coordination of the BioRespository inventory and fill rate, as needed, at weekly meetings.
- Assists in the preparation of protocols, reports, summaries and other documents as needed.
- Assists and provides input for annual budgets and Annual Reports prepared by the Laboratory Director.
- Performs all other duties as assigned.
Required Knowledge, Skills, and Abilities: Knowledge of all aspects of coordinating the implementation of a clinical trial, working with clinical trial sites and managing specimen scheduling and projections. Experience working with specimen management systems, Freezerworks preferred, FreezerPro a plus for tracking receipt, processing, storage and re-distribution of specimen aliquots. Knowledge of specimen processing of all aspects of processing blood conforming to pre-analytical test requirements for serum, plasma, whole blood, PBMC and other clinical specimens. Familiar with CAP/CLIA and GCLP regulations pertaining to biospecimen processing and Federal and international shipping regulations including IATA. IATA certification a plus but not required. Excellent communication skills and writing skills. Excellent analytical skills in the preparation of data reports, tracking metrics and creating graphs in Excel.
Minimum Education/Training Requirements: Bachelors or Master Degree in Sciences or Public Health
Minimum Experience: 2-3 years experience as a Study Coordinator implementing clinical trials in a laboratory setting. 2-3 years experience working with specimen management systems, analyzing and reporting data.
Work Environment: Henry M. Jackson Foundation at 13 Taft Court, Rockville, MD.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.