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 lead an interdisciplinary team of results quality control reviewers and to ensure that the results review teams’ decisions and activities are in alignment with regulation and policy and in support of the mission and priorities of ClinicalTrials.gov, the largest publicly available clinical study registry and results database in the world. NLM is one of 27 Institutes and Centers 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. The Staff Scientist I for NCBI’s ClinicalTrials.gov resource exercises scientific and technical expertise to coordinate the collection and curation of clinical trial records by sponsors and investigators worldwide and regulatory and policy knowledge to support 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 as the ClinicalTrials.gov Results Team Lead. This candidate will be responsible for:
• supervising team projects, tasks and activities;
• communicating the program/project objectives and monitoring progress;
• devising work plans and prioritizing tasks to ensure that objectives are met and completed in a timely manner;
• evaluating and communicating individual and overall team performance and recommending and instituting solutions for quality and process related issues;
• serving as a subject matter expert (SME) to ensure that questions and issues are resolved in a way that is consistent with Results Review Criteria and legal and policy-related clinical trial-reporting requirements, to identify and escalate policy and regulation questions that need higher level resolution, and to identify, develop, and institute new Results Review Criteria and procedures, when necessary;
• providing oversight of training activities for new and existing staff to ensure consistent understanding and application of Results Review Criteria and procedures and identifying training needs and implementing ongoing trainings, as needed;
• communicating regularly with the federal and contract supervisors to discuss team activities, provide status updates, discuss progress and review the team’s performance;
• serving as ClinicalTrials.gov operational management staff to help achieve operational goals with collaborations among program staff, including Registration Team Lead, reviewers, information specialists, project managers, developers, consultants, business analyst, and modernization teams;
• contributing to stakeholder engagement activities, including leading workshops, presentations, and developing resources to help data submitters and the public learn more about clinical trial results reporting at ClinicalTrials.gov;
• 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 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 U.S. Food and Drug Administration (FDA), NLM, and other federal government agencies, such as Office for Human Research Protections (OHRP), Centers 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 postdoctoral experience from an accredited college in a biomedical science, public health, or related discipline and three or more years of experience in reviewing clinical trial information submitted to ClinicalTrials.gov.
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 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.
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 2019 (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 Ethical Conduct.
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, NLM3448-2002, in the cover letter and email subject line. Review of applications will begin on October 4, 2022. Applications will be accepted until the position is filled.
Do not include your birth date, social security number (SSN), or personal photograph on application materials.
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