International Laboratory Operations Specialist (ACESO)

Updated: December 6, 2018
Job ID: 214348
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

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HJF is seeking an International Laboratory Operations Specialist to support the Joint West Africa Research Group (JWARG) division of the Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO). This position is based in Bethesda, Maryland, but will require frequent travel to Liberian and Ghanaian study sites, and other West African sites as needed. This position will report to the ACESO Program Manager. HJF provides scientific, technical and programmatic support services to ACESO.

ACESO is implementing clinical research programs internationally and requires a candidate to support clinical laboratory activities implemented in Ghana and Liberia. The incumbent will work closely with the site laboratory staff, project manager, site PIs, key clinical staff, and ACESO personnel in carrying out responsibilities and providing feedback on clinical research activities. The incumbent will facilitate information flow between various ACESO departments and JWARG study team members at the West Africa clinical research sites. The incumbent will support the in-country laboratories and will assist the site and ACESO staff with evaluation, development, oversight, set-up, training, monitoring, and review of the laboratory to ensure quality practices are applied as required for ACESO clinical studies. The ACESO investigators and study leads will provide support and technical input for project plans, including timelines, related to laboratory operations to integrate activities.

ACESO is a fast growing international clinical research group with a collaborative team atmosphere, focus on the mission, and high expectations for individual performance. The International Laboratory Operations Specialist must learn quickly, demonstrate considerable judgment, perform well under pressure, act independently, and adapt easily to new challenges. The International Laboratory Operations Specialist will also work closely with the ACESO leadership to develop and implement targeted projects to strengthen the overall program execution. The International Laboratory Operations Specialist must be able to quickly assess complex problems, develop adaptable strategies, and work with internal and external partners to implement resolution.

Responsibilities:

  1. Ensure that adequate operational supplies are available. Monitor instrument maintenance and equipment to ensure items are maintained according to manufacturer’s specifications and organizational standards.

  2. Research, test, and evaluate new clinical laboratory procedures, equipment, and supplies, as required by protocol and standards.

  3. Develop programs of instruction, such as safety, quality assurance, chemical hygiene, and conduct required in-service training sessions. Ensure staff is sufficiently trained to perform tasks independently.

  4. Conduct site qualification/evaluation on behalf of ACESO to assess feasibility to conduct studies/trials including review of staffing needs.

  5. Work with ACESO International Program Scientist to ensure laboratory is operational at minimum requirements per study and to execute studies as required.

  6. Facilitate the implementation and management of assigned clinical studies including but not limited to: review of laboratory specific procedures in protocols, Laboratory SOP/SSPs, training manuals, laboratory supplies, and technical support.

  7. Hands on review/development of laboratory specific documents to ensure meets minimum standards, such as GCLP.

  8. Assists in ensuring staff training records are maintained to include GCLP standards.

  9. Anticipate and identify laboratory critical path and communicate priorities to protocol teams on the ground and ACESO.

  10. Participate in relevant ACESO site and study team calls.

  11. Assist site in preparing for upcoming monitoring and audit visits.

  12. Review monitoring and audit reports for tracking and trending of issues, follow up on resolution, and escalate as needed.

  13. Facilitate the development and/or updates to laboratory quality management plans.

  14. Conduct internal monitoring/QA activities and refresher training as needed.

  15. Facilitate in gathering data and supplies needed for study and site logistics

  16. Prepare technical reports, summaries, and protocols as required by ACESO.

  17. Maintain clear and accurate laboratory records, inventories, and logbooks.

  18. Plans work to be accomplished by laboratory personnel, set and adjusts short-term priorities, prepares schedules for completion of work to ensure efficient and accurate testing.

  19. Prepares, writes, reviews, and revises the standard operating procedures (SOPs) for the laboratory, writes technical functions that serve as guidance to laboratory personnel, Prepares as well annual reports of the GCLP activities.

  20. Coordinates manufacturer service contracts, service visits and call-outs if the instruments break down.

  21. Complete other duties as assigned.

Required Knowledge, Skills, and Abilities: 

  • Possesses excellent written and oral communication skills.

  • Ability to manage multiple priorities on different timelines, flexibility to handle a variety of tasks.

  • Excellent organization, time, and project management skills with strong interpersonal skills Strong familiarity with clinical diagnostic laboratory procedures, GCLP, laboratory supplies, and equipment preferred.

  • Ability to effectively interact with local and international external collaborators in a culturally sensitive manner.

  • Ability to work as an effective team member in an in-person and in a virtual environment.

  • High level of initiative and drive.

  • Familiarity with laboratory supplies, processes, and equipment preferred. 

  • Ability to work in a fast-paced international research environment and coordinate multiple priorities on different timelines. 

  • Flexibility to handle a variety of tasks and shift priorities as necessary

  • Proficiency in standard Microsoft Office software required.

Minimum Education/Training:  Master’s degree in medical/clinical laboratory science or related life/health science discipline required.

Minimum Experience:  4-6 years of working experience in a clinical diagnostic or clinical research laboratory setting. Experience with clinical research trials, development and management of laboratory procedures and documentation, and biosafety. Experience in infectious disease, infection prevention and control (IPC), and/or microbiology are desirable.

Physical Capabilities: Frequent standing, sitting, walking, lifting and traveling.

Work Environment: Regular travel to study sites for several weeks at a time. Primarily laboratory environment in Ghana and Liberia. Position based in office environment at Bethesda, Maryland ACESO-HQ.

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.

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