This position is located within the Division of Extramural Activities (DEA), Division of Clinical Research (DCR). The incumbent will report directly to the Associate Director of DCR.

Duties

Manage and oversee clinical and operational activities that are part of the broad national program of clinical research. Promote the safety and well-being of patients participating in clinical research supported by the NINDS extramural programs. Assess needs and opportunities for clinical research and the ongoing evaluation of these clinical research programs. Perform oversight and management pertaining to the regulatory and procedural aspects of clinical site monitoring and performance evaluation. Provide technical guidance to outside investigators asking funding for new clinical studies on their research objectives/hypotheses, study design and safety monitoring plans. Develop training material and conduct training sessions for other clinical trials specialists and clinical site coordinators.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• Employment is subject to the successful completion of the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.)
• Males born after December 31, 1959 must be registered with the Selective Service.
• Applicants must meet all qualifications requirements within thirty (30) calendar days of the closing date of this announcement, including time in grade.
• This position has a positive education requirement. Please provide a copy of your transcripts.
• If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450. This information is required annually. For information, visit the NIH Ethics website: https://ethics.od.nih.gov/topics/fd.htm.

Qualifications

Basic Education Requirement: In order to qualify for a Clinical Research Project Manager, GS-0601, position you must have successfully completed a full 4-year course of study in an accredited college or university leading to a Bachelor's degree or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained. In addition, in order to qualify for the Clinical Research Project Manager at the GS-14 level, you must: Demonstrate in your resume at least one (1) year of qualifying specialized experience equivalent to the GS-13 level in the Federal Government, performing the following types of tasks: providing operational oversight of clinical research, safety monitoring, and day-to-day research management issues; establishing procedures for clinical site monitoring; collaborating with physicians and research staff in the development, review, management, and evaluation of research protocols; directing and evaluating clinical research studies. You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay. Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12256780

Education

This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades). Unofficial transcripts will be accepted in the application package. Official transcripts will be required from all selectees prior to receiving an official offer. Click here for information on Foreign Education.

Contacts

• Address National Institutes of Health 6701 Rockledge Drive Bethesda, MD 20892 US
• Name: Michael Kennedy
• Phone: 301-402-6865
• Email: [email protected]