Associate Study Director-Clinical Studies Support Team Lead

2 weeks ago

MD United States Laulima Government Solutions Full time
Job Title: Associate Study Director-Clinical Studies Support Team

Lauded for their expertise in clinical studies support, we are seeking a highly skilled Associate Study Director-Clinical Studies Support Team to join our esteemed team at Laulima Government Solutions. This exceptional individual will play a pivotal role in supporting our government client at Fort Detrick, Maryland.

Key Responsibilities:
  • Participate in the development and execution of research studies that align with the mission of the Integrated Research Facility and NIAID Special Projects.
  • Provide expert support for clinical studies focused on 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 of assays and methods to in-country laboratories; and other capacity-building efforts.
  • Participate in the design and execution of laboratory support of IRF/NIAID studies, such as screening of medical countermeasures for efficacy in vitro and in vivo, sequencing and bioinformatics, and may extend to other disciplines related to virology.
  • Generate high-quality interim and final study reports. Contribute to scientific publications in international peer-reviewed journals.
  • Actively participate in practices/processes to enhance data quality and integrity, including periodic review of study execution to identify gaps and refine procedures.
  • Develop and revise Standard Operating Procedures and methods for laboratory operations.
  • Provide support to the Clinical Study Support Team members and ensure efficient and timely communication and reporting regarding team projects, progress, and team members to Study Director.
  • Other duties as assigned by supervisor.
Requirements:
  • Ph.D. or equivalent degree in Microbiology, Public Health, or related discipline from an accredited college or university preferred.
  • Candidates with an M.S. degree and extensive experience may be considered.
Preferred Qualifications:
  • 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.
  • Willingness to participate in periodic drug screening.
  • 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.
  • Able to wear respiratory protection.
Desired Skills and Experience:
  • 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.
  • Demonstrate interpersonal, oral, and written communication, and organizational skills.
  • Demonstrate 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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