|STAFF SCIENTIST 1 (ClinicalTrials.gov Lead Policy Research Analyst)
NATIONAL LIBRARY OF MEDICINE, BETHESDA, MARYLANDPOSITION INFORMATION
The National Library of Medicine (NLM), National Center for Biotechnology Information
(NCBI) is recruiting for a Staff Scientist I in the Information Engineering Branch (IEB) to
support the scientific policy management of ClinicalTrials.gov, the largest publicly
available clinical study registry and results database in the world. NLM is one of 27
Institutes at the National Institutes of Health (NIH), part of the Department of Health and
Human Services (HHS).NCBI performs research in computational biology and creates and maintains
information systems and computational tools for the biological research community.
This involves the exercise of technical skills to coordinate the collection and curation of
study information submitted by sponsors and investigators worldwide and the
implementation of legal and policy-related clinical trial-reporting requirements.
NLM IEB is looking for an outstanding candidate to work on NCBI¡¦s ClinicalTrials.gov
resource with the Lead Policy Research Analyst.
This candidate will be responsible for:
Ensuring that the ClinicalTrials.gov website and database development, curation,
scientific research, policy, outreach, and other strategic program areas are
aligned with policy requirements;
* coordinating scientific policy work priorities and policy implementation as part of
ClinicalTrials.gov ongoing operations;
* communicating responses to policy inquiries made by responsible parties,
namely, NIH, Office of Science Policy (OSP), Office of Extramural Research
(OER), and other federal government agencies, such as Government
Accountability Office (GAO), HHS, Office of Research Integrity (ORI), and
congressional and external stakeholders in collaboration with NLM policy;
* supporting staff development opportunities;
* monitoring domestic and international policies and advising on potential program
responses and actions;
* addressing policy issues related to the design, operation, and implementation of
* conducting research aimed at improving the clinical trial reporting system across
the clinical research enterprise generally and at ClinicalTrials.gov specifically;
* considering ways to utilize other publicly available information at U.S. Food and
Drug Administration (FDA), NLM, and other federal government agencies, such
as Office for Human Research Protection (OHRP), Center for Disease Control
and Prevention (CDC), and Centers for Medicare and Medicaid Services (CMS),
to provide context for the research; and
* accessing comprehensive NLM core facilities and the unique and extensive
resources of the NIH.
The ideal candidate may or may not be a United States citizen and must have a Ph.D.
or equivalent and postdoctoral experience.
We are looking for an individual with:
* an outstanding track record of supporting the management of a complex
scientific and policy program area;
* Knowledge of ClinicalTrials.gov, federal, and international trial reporting
regulations and policies;
* Knowledge of Section 801 of the FDA Amendments Act of 2007 (FDAAA 801)
and the Final Rule for Clinical Trials Registration and Results Information
Submission (¡§the Final Rule¡¨) and experience in conducting registration and
results review in accordance with FDAAA 801 and the Final Rule.;
* practical experience in applying regulations related to clinical research;
* demonstrated sound judgment in applying scientific, regulatory, and policy
knowledge to support the management of a multi-disciplinary program;
* Experience with both research and policy analysis skills, especially as related to
the design, implementation, and regulation of databases;
* a track record of using appropriate research methods to evaluate policy in clinical
research and health care and analysis of content from the ClinicalTrials.gov
* Excellent communication, project management, and organizational skills; and
* a proven ability to successfully engage in a multi-disciplinary collaborative
projects and research.
Applicants who have completed part or all their education outside of the United States
must have their foreign education evaluated by an accredited organization to ensure
that the foreign education is equivalent to education received in accredited educational
institutions in the United States. Only the completed foreign education evaluation will be
accepted. For more information on foreign education verification, visit the National
Association of Credential Evaluation Services (NACES) website. Verification must be
received prior to the effective date of the appointment.
Employees, contractors, trainees, and volunteers providing healthcare or services in
support of healthcare (Healthcare Workforce) may be required to receive a coronavirus
disease (COVID-19) vaccine because they are expected to perform duties that put them
in contact or potential contact with patients. COVID-19 vaccination and other
vaccination documentation from Healthcare Workforce personnel may be requested at
any point during the onboarding process or at any time during employment with NIH.
For more information on this requirement, visit the Safer Federal Workforce page on
vaccines. To get a COVID-19 vaccine, please visit Vaccines.gov.
Salary is commensurate with research experience and accomplishments. A full package
of benefits, including retirement, health, life, and long-term care insurance, Thrift
Savings Plan participation, etc., is available. All employees of the federal government
are subject to the conflict-of-interest statutes and regulations, including the Standards of
HOW TO APPLY
Interested individuals should send a copy of their CV and Bibliography with the names
of three references along with a cover letter detailing research interests. Send all
information to firstname.lastname@example.org. Please include the Job Announcement
number, NLM3449-2022, in your cover letter and email subject line. Applications will be
accepted until the position is filled.
Do not include your birth date, social security number (SSN), or personal photograph on
COMMITMENT TO DIVERSITY AND EQUAL EMPLOYMENT OPPORTUNITY
NIH/NLM encourages the application and nomination of qualified women, minorities,
and individuals with disabilities. The U.S. government does not discriminate in
employment based on race, color, religion, sex (including sexual orientation, pregnancy,
and gender identity), national origin, political affiliation, marital status, disability, genetic
information, age, membership in an employee organization, retaliation, parental status,
military service, or other non-merit factors. NIH/NLM will provide reasonable
accommodations to applicants with disabilities as appropriate. If you require reasonable
accommodation during any part of the application and hiring process, please notify us.
DHHS, NIH, and NLM are equal-opportunity employers