Senior Clinical Study Director

4 weeks ago

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

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.

This role will participate in the development and execution of research studies that support the mission of the Integrated Research Facility and NIAID Special Projects.

The ideal candidate will provide support for clinical studies for high consequence and emerging or re-emerging pathogens in high- and low-resource settings.

Key responsibilities include:

  • Providing Subject Matter Expert (SME) advice and support for laboratory capability development in domestic and international settings.
  • Developing and implementing training and cross-training programs to assure continuity of operations and scientific core activities.
  • Deploying to international locations to provide laboratory support for clinical trials, research studies, and outbreak preparedness/response activities.
  • Training staff and in-country personnel in laboratory safety procedures and handling of high consequence pathogens and clinical specimens.
  • Participating in design and execution of laboratory support of IRF/NIAID studies.
  • Generating high quality interim and final study reports.
  • Generating and contributing to scientific publications in international peer-reviewed journals.
  • Actively participating in practices/processes to enhance data quality and integrity.
  • Developing and revising Standard Operating Procedures and methods for laboratory operations.
  • Providing support to the Clinical Study Support Team members.

Requirements include:

  • Professional experience in virology, molecular biology, immunology, or public health.
  • Four years of specialized training in research.
  • 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.
  • Ability to obtain/maintain certification in Chemical Personnel Reliability Program and/or Biological Personnel Reliability Program.
  • 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.
  • Ability to work independently, design experiments, and analyze data.
  • French language proficiency.
  • Citizen or Permanent Resident.

The Alaka`ina Foundation Family of Companies offers a competitive benefits package, including medical, dental, disability, and life insurance coverage; tuition reimbursement; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans.

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