Clinical Regulatory and Operations Specialist

1 week ago

Bethesda, Maryland, United States American Society for Virology Full time
Jobs in Virology by ASV - Clinical Regulatory and Operations Specialist

Clinical Regulatory and Operations Specialist

National Institute of Allergy and Infectious Disease

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Categories:
Other

Job Type/Arrangement:
Full Time

Description:
Division of Clinical Research
Collaborative Clinical Research Branch

The National Institute of Allergy and Infectious Diseases (NIAID), one of the largest institutes at the National Institutes of Health (NIH) and part of the Department of Health and Human Services (HHS), conducts and supports a global program of research to better understand treat, and ultimately prevent infectious, immunologic, and allergic diseases.

The Collaborative Clinical Research Branch (CCRB), Division of Clinical Research (DCR), NIAID, seeks a highly motivated and proactive candidate for a pharmacist position to oversee pharmacy aspects of domestic and international clinical trials.

The CCRB actively supports and complements NIAID intramural and extramural programs by developing the research capacity of domestic and international clinical research networks and researchers.

This includes launching emergency research responses to high-consequence emerging disease threats with the potential to cause an epidemic, pandemic, or other significant public health event anywhere in the world but likely in regions with little to no clinical research infrastructure.

These projects require specific capacity and emergency response skills that involve navigating difficult circumstances, such as conducting collaborative research in conflict zones, determining pathways for logistical support for regions lacking mechanisms to ship and receive goods and services, and creating research capacity quickly in settings with varying amounts of prior clinical trials research experience.

In addition, CCRB engages in high-level diplomatic and partnership management with world and national government leaders, non-governmental organizations, the World Health Organization, and many others.

The pharmacist position requires the incumbent to make immediate, diplomatic, technically accurate, creative, and mission-aligned decisions and actions to rapidly respond to and deploy lifesaving resources during an infectious disease outbreak and to perform ongoing capacity building with existing sites to ensure readiness to conduct additional clinical research.

The pharmacist position has a broad range of responsibilities that include but are not limited to the following:

  • Serve as DCR's clinical research pharmacy authority by providing technical, scientific, and managerial leadership and support in response to global public health infectious disease emergencies, with an emphasis on international clinical research activities conducted at special project sites, often in resource-poor developing countries.
  • Act as a clinical research pharmacist consultant by collaborating with domestic and international clinical research networks to develop and implement clinical trials, direct start-up activities, coordinate clinical site preparation/renovation, assess factors that may significantly affect a site's clinical research and pharmacy capacity/operations, and devise solutions and/or approaches to mitigate potential issues.
  • Provide pharmacy leadership as part of a clinical research team and liaise with the host country's clinical responders, establish clinical care research partnerships at strategic sites, and rapidly initiate clinical site preparation for protocol implementation.
  • Support and provide oversight on domestic and international site pharmacy involvement in clinical trials, including site assessments, cold chain management, standard operating procedure development, training, capacity building, identification and resolution of pharmacy issues, patient safety oversight issues, and day-to-day investigational drug management issues.
  • Use independent judgment and resourcefulness to apply policies, guidelines, and procedures to correct problems and modify processes to meet CCRB's unique working conditions and its different and varying clinical research program operational needs.
  • Conduct domestic and international site visits to ensure sites are operating under all applicable regulations, guidelines, policies, and standards.
  • Direct, coordinate, and oversee the procurement, distribution, and use of pharmaceutical products and investigational drugs and ensure consistent management of the inventory, including importation of investigational and other pharmacy-related products and equipment.
  • Maintain current, up-to-date knowledge and understanding of pharmaceutical issues, clinical research policies, regulations, best practices, and compliance requirements necessary to support domestic and international special project site clinical research pharmacy activities.
  • Provide expert pharmaceutical advice and assistance to program staff, clinical investigators, and site pharmacists involving investigational agent properties, pharmaceutical handling procedures for storage and preservation, preclinical and toxicity data, and drug-drug interactions.
  • Assist with writing manuscripts/abstracts/posters and present information on clinical research programs, including publication of study results and findings, at scientific meetings and professional conferences.
Qualifications
Required

  • Doctor of Pharmacy (PharmD) from an accredited U.S. institution
  • Current licensure in pharmacy in a state or territory of the U.S. or the District of Columbia
  • Experience as a research pharmacist working with clinical trials
  • Experience in identifying and analyzing problems and constructing solutions to a variety of scientific and program/project management issues affecting clinical trials
  • Ability to travel
Preferred

  • Infectious diseases experience
  • Management experience/strong leadership skills
  • Knowledge of best practices and regulations related to sterile compounding
  • Knowledge of cold chain management
  • French language ability
  • Ability to work independently and make decisions based on available knowledge
  • Works well in a team-oriented environment
  • Flexible and willing to perform other tasks as needed/assigned
  • Excellent written and oral communication skills
  • Ability to plan, organize, manage, and coordinate multiple complex assignments and prioritize conflicting requirements
  • Ability to understand and adhere to local cultural norms and political sensitivities
To Apply
Visit the clinical regulatory and operations specialist vacancy announcement numbers NIH-NIAID-DE U.S. citizens) and/or NIH-NIAID-MP status candidates) to submit your application. Applications must be submitted online from January 8, 2024, until 11:59 p.m. Eastern Time on January 12, 2024.
Visit NIAID Careers for more information about working in NIAID's dynamic atmosphere.
HHS, NIH, and NIAID are equal opportunity employers dedicated to diversity, equity, inclusion, and accessibility.

Education Requirement:
Doctor of Pharmacy (PharmD) from an accredited U.S. institution

Location:
Bethesda, MD

National Institute of Allergy and Infectious Diseases

9000 Rockville Pike
Bethesda , Maryland

20892

US
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Contact:
Colleen Kelly,

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