- 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.
- 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
- 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
-
Office Operations Specialist
2 weeks ago
SoftwareONE Bethesda, United StatesWhy SoftwareOne? For over 30 years SoftwareOne has been the foundation for organizations around the world for their technology solutions. With changes in the market from on-premises to cloud we have always been one step ahead. Underpinning our transitions and evolutions are our s ...
-
American Society for Virology Bethesda, United StatesDivision 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), co ...
-
Operations Specialist
1 day ago
The Tatitlek Corporation Washington, United States Regular Full timeOverview · This position is located in the Office of Inspector General, Office of Management and Policy (OMAP), Division of Procurement and Administrative Services, Branch of Administrative Services. The Operations Specialist shall provide customer service in the full range of a ...
-
GEICO Chevy Chase, United States Full timeGEICO's Communications Department is seeking a strong writer and communications strategist to join the Internal Communications Team. In this role, you will be responsible for informing, engaging, and inspiring GEICO employees through effective, strategic internal communications. ...
-
IT Operations Specialist
2 weeks ago
Frontify Washington, United States Full timeYour new company A lot has changed at Frontify over the last decade, but people continue to be at the heart of our vision. Every day, we empower thousands of brand builders worldwide — including teams at Lufthansa, KIA, Vodafone, and Uber — to create brands that have an impact. O ...
-
Operations Specialist
1 week ago
Galapagos Federal Systems Arlington, United StatesJob Title: Operations Specialist -4777 · Job Location: The Pentagon, Arlington, VA 20301 · Job Summary · Galapagos Federal Systems LLC is looking for an enthusiastic, well-qualified individual to fill the Operations Specialist position and to join our team of qualified, divers ...
-
Center Operations Specialist
4 weeks ago
United Service Organizations (USO) Bethesda, United StatesWhy join our team? · With a mission that spans the globe, the USO provides a rewarding and fulfilling work environment. Our team is exceptional, and we offer generous paid time off, including volunteer days and military leave. We have a remarkable 401k match, comprehensive benef ...
-
Business Operations Specialist
5 days ago
ASRC Federal Washington, United States Full timeJob Description · JOB DESCRIPTION: · The Technical Countermeasure Program Specialist (Business Analyst) is responsible for managing projects and budgets related to implementing technical countermeasures to mitigate threats to Federal facilities. Projects managed include alarm ...
-
Business Operations Specialist
1 week ago
ASRC Federal Washington, United StatesASRC Federal Broadleaf Division is hiring a Business Operations Specialist- Senior in support of SOCOM in Washington DC. This position is approved for a telework work schedule depending on experience. · JOB DESCRIPTION: · The Technical Countermeasure Program Specialist (Business ...
-
Sales Operations Specialist
5 days ago
cellebrite Washington, United States Full timeAbout The Position · About our mission: · Cellebrite's (Nasdaq: CLBT) mission is to enable its customers to protect and save lives, accelerate justice, and preserve privacy in communities around the world. Cellebrite is a global leader in Digital Intelligence solutions for the ...
-
Operations Support Specialist
5 days ago
SoBran, Inc. Washington, United StatesJob Description · Join The Winning Team...Team SoBran At SoBran, we care about people. SoBran's success hinges on our employees. We maintain a professional environment and ensure that our people have the tools and training to achieve; and opportunities for learning and advancemen ...
-
Program Operations Specialist
3 weeks ago
Beacon Hill Washington, United StatesOur client, a non-profit organization, is seeking a temporary Program Operations Specialist to support their team in Washington, DC · About the Job: · Maintain project documentation and perform tasks such as target research, fieldwork, and drafting team charters. · Assist in adhe ...
-
Operations Specialist II
1 week ago
Capstone Washington, United States Part timeCSA is looking for a Part-time Operations Specialist II to provide 24/7, on-site support in monitoring, collecting and sharing all aspects of reporting information associated with the operations of the Commander Navy Installation Command (CNIC) Shore Enterprise Operations Center ...
-
Guidelines Operations Specialist
2 weeks ago
INFECTIOUS DISEASES SOCIETY OF AMERICA INC Arlington, United States OTHERDescription · The Infectious Diseases Society of America (IDSA) is seeking a Guidelines Operations Specialist. IDSA is a community of over 13,000 physicians, scientists and public health experts who specialize in infectious diseases. Our mission is to improve the health of ind ...
-
Operations and Exercise Specialist
1 week ago
Booz Allen Hamilton Arlington, United StatesOperations and Exercise SpecialistKey Role: · Perform client-site work to develop and maintain detailed contingency operations plans, exercise plans, and emergency action plans requiring extensive inter-organizational coordination. Assist with operational and leadership training ...
-
Operations Specialist
3 weeks ago
MDDC Credit Union Association Rockville, United StatesWelcome to Lafayette Federal Credit Union Careers Our organization is growing, and we are seeking top-notch individuals to provide support to our members. Our employees are a critical component in our endeavor to be the premier financial partner for every one of our members. · Ca ...
-
Installation Operations Specialist
2 weeks ago
LMI Washington, United StatesOverview · This position will be responsible for assisting the federal government in determining the most efficient and cost-effective ways to operate across their portfolio. The SME shall have experience in facility management for federal installations at a headquarters level. ...
-
Customer Operations Success Specialist
1 day ago
Xometry Silver Spring, United StatesXometry (NASDAQ: XMTR) powers the industries of today and tomorrow by connecting the people with big ideas to the manufacturers who can bring them to life. Xometry's digital marketplace gives manufacturers the critical resources they need to grow their business while also making ...
-
Installation Operations Specialist
3 weeks ago
LMI Washington, United StatesOverview · This position will be responsible for assisting the federal government in determining the most efficient and cost-effective ways to operate across their portfolio. The SME shall have experience in facility management for federal installations at a headquarters level. A ...
-
Operations Analyst/Specialist
2 weeks ago
Astor & Sanders McLean, Virginia, United States PermanentOperations Analyst · Astor & Sanders Corporation (Astor) is an award-winning IT solutions provider headquartered in McLean, VA and is seeking an Operations Analyst. This is a full-time position based in Mclean, VA. This is a hybrid role with three days onsite in McLean required. ...
Clinical Regulatory and Operations Specialist - Bethesda, United States - American Society for Virology
Description
Jobs in Virology by ASV - Clinical Regulatory and Operations SpecialistClinical Regulatory and Operations Specialist
National Institute of Allergy and Infectious Disease
Tweet
Apply Bookmark Report
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:Required
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
The specified credentials are invalid. You can sign up for a free developer account at
Road
2 miles
5 km
Terms
Contact:
Colleen Kelly,
Apply Bookmark Report
About ASV
The American Society for Virology promotes exchange of information and stimulates discussion and collaboration among virologists.
Learn More Join ASV
Candidates
My Job Board
My Profile
Job Search
Employers
Employer Profile/Jobs
Candidates Tracker
Search Tools
Follow ASV
Copyright 2018 American Society for Virology (ASV) . All Rights Reserved.
#J-18808-Ljbffr