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 a component of 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.
The 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;
- communicating responses to policy inquiries made by responsible parties, NIH, OSP (Office of Science Policy), OER (Office of Extramural Research) and other federal government agencies (Government Accountability Office, HHS), and congressional and external stakeholders;
- supporting staff development opportunities;
- monitoring domestic and international policies and advising on potential program responses and actions;
- addressing policy issues related to the design and operation of ClinicalTrials.gov;
- 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 the U.S. Food and Drug Administration (FDA), NLM, and other federal government agencies (Office for Human Research Protections (OHRP), Center for Disease Control (CDC), 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.
QUALIFICATIONS/ELIGIBILITY:
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;
- experience in data collection and curation of clinical trial registration and results information based on specified quality control review criteria;
- a track record of evaluating clinical study records to identify apparent errors, deficiencies, or inconsistencies;
- Knowledge of Section 801 of the Food and Drug Administration 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 reviews 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 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 databases;
- excellent communication, project management, and organizational skills; and
- a proven ability to successfully engage in a multi-disciplinary collaborative projects and research.
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 Ethical Conduct.
HOW TO APPLY:
Interested individuals should send a copy of their CV and Bibliography with names of three references. Include a cover letter detailing research interests. Send all information to ncbijobs@ncbi.nlm.nih.gov. Please include the Job Announcement number, NLM19-0001, in your cover letter. Review of applications will begin on or about August 12, 2021, but applications will be accepted until the position is filled.
The successful candidate will serve on a non-competitive and time-limited, renewable position in the excepted service. Equal opportunity employment is held as one of the most important values at NIH. Selection for this and any other position will be based solely on merit. NIH does not discriminate on the basis of race, color, religion, sex, national origin, politics, marital status, sexual orientation, physical or mental disability, age or membership or non-membership in an employee organization.
DO NOT INCLUDE YOUR BIRTH DATE OR SOCIAL SECURITY NUMBER (SSN) ON APPLICATION MATERIALS.
DHHS AND NIH ARE EQUAL OPPORTUNITY EMPLOYERS
Last Reviewed: August 12, 2021