Study Coordinator - Diagnostics and Countermeasures Branch

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HJF is seeking a Study Coordinator to support the Diagnostics and Countermeasures Branch (DCB) located at 13 Taft Court in Rockville, MD. HJF provides scientific, technical and programmatic support services to DCB.

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 will oversee the day-to-day administrative requirements for supporting Institutional Review Board (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 from clinical trials and other research activities conducted by the Diagnostics and Countermeasures Branch (DCB), U.S. Military HIV Research Program (MHRP), the Emerging Infectious Diseases Branch (EIDB), 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 monitoring the BioRepository database and providing data reports in SPL/BioR management meetings.

  1. Reports to the Senior Project Manager - Clinical Research.
  2. Manages and receives shipments and oversees sample inventory and documentation in accordance with the laboratory procedures and relevant guidelines.
  3. 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.
  4. 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 and Senior Project Manager - Clinical Research of any issues/concerns.
  5. Oversees all specimen receiving, shipping, and relevant data entry for clinical trials supported by the SPL/BioR.
  6. Participates on protocol calls and provides updates pertaining to SPL/BioR. Summarizes decisions and action items relevant to the SPL/BioR and provides summaries to the Laboratory Director, Laboratory Manager and Program Coordinator.
  7. 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.
  8. 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 and any supporting documentation. Development of Study Analytical Plans will be generated in conjunction with the DCB Project Management Team.
  9. Prepares weekly schedule of specimens to be processed for each protocol. Communicates with clinical trial sites to update information needed to complete the weekly schedule.
  10. 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, Walter Reed Army Institute of Research (WRAIR) and applicable regulatory agencies.
  11. Reviews and updates all Standard Operating Procedures (SOPs), or other relevant documents and works closely with the Laboratory Leadership.
  12. 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.
  13. 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 BioRepository inventory and fill rate, as needed, at weekly meetings.
  14. Assists in the preparation of protocols, reports, summaries and other documents as needed.
  15. Assists and provides input for annual budgets and annual reports prepared by the Laboratory Director.
  16. Communicate DCB site closures to Clinical sites.
  17. 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. Excellent communication skills and writing skills. Excellent analytical skills in the preparation of data reports, tracking metrics and creating graphs in Excel. Experience working with collaboration or project management software, Smartsheet preferred.

Minimum Education: Bachelor's degree in public health or science related field required.

Minimum Experience/ Training Requirements: Minimum 3-5 years of relevant work experience required.

Physical Capabilities: Requires lifting material up to 25lbs.

Work Environment: Set in an office work environment. Evening, holiday, or weekend work is occasionally required.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

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