Associate Study Director-Clinical Studies Support Team Lead

3 days ago

Frederick, Maryland, United States Alaka`ina Foundation Family of Companies Full time

Job Summary:

The Alaka`ina Foundation Family of Companies is seeking a highly skilled Associate Study Director-Clinical Studies Support Team to support our government client at Fort Detrick, Maryland.

Responsibilities:

  • Participate in the development and execution of research studies that support the mission of the Integrated Research Facility and NIAID Special Projects.
  • Provide support for clinical studies for high-consequence and emerging or re-emerging pathogens in high- and low-resource settings.
  • Offer Subject Matter Expert (SME) advice and support for laboratory capability development in domestic and international settings.
  • Develop and implement training and cross-training programs to ensure continuity of operations and scientific core activities.
  • Deploy to international locations to provide laboratory support for clinical trials, research studies, and outbreak preparedness/response activities.
  • Train staff and in-country personnel in laboratory safety procedures and handling of high-consequence pathogens and clinical specimens.
  • Implement and troubleshoot assays in low-resource environments.
  • Transition assays and methods to in-country laboratories.
  • Contribute to the design and execution of laboratory support of IRF/NIAID studies.
  • Generate high-quality interim and final study reports.
  • Contribute to scientific publications in international peer-reviewed journals.
  • Participate in practices/processes to enhance data quality and integrity.
  • Develop and revise Standard Operating Procedures and methods for laboratory operations.
  • Provide support to the Clinical Study Support Team members.

Requirements:

  • Ph.D. or equivalent degree in Microbiology, Public Health, or related discipline from an accredited college or university.
  • Professional experience in virology, molecular biology, immunology, or public health.
  • Four years of specialized training in research.
  • Experience in Next Generation Sequencing methods for detection and identification of emerging and/or novel human pathogens.
  • Experience in bioinformatics tools for pathogen discovery and genome assembly.
  • Ability to obtain/maintain DOJ Security Risk Assessment approval.
  • Willingness to be immunized with licensed and FDA-approved Investigational New Drugs recommended for persons at risk for occupational exposure to biological agents.
  • Ability to obtain/maintain certification in Chemical Personnel Reliability Program and/or Biological Personnel Reliability Program.
  • Ability to obtain/maintain CDC Select Agent Program approval.
  • Ability to work in a biosafety level 4 setting with select agents.

Preferred Qualifications:

  • Proficiency in genomic analyses tools for primer design, genome reference mapping, genome de novo assembly, pathogen detection, and discovery.
  • Basic understanding of laboratory information management systems.
  • Interpersonal, oral, and written communication, and organizational skills.
  • Ability to work independently, design experiments, and analyze data.
  • French language proficiency.

Clearance Requirements:

  • Must be a U.S. Citizen or Permanent Resident.
  • Must be able to meet the requirements for T3 level investigation.

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