This position is located in the extramural program of the National Institute of Mental Health (NIMH). The incumbent of this position serves as a principal advisor to the Director of OCR and provides administrative and scientific leadership on clinical research issues across NIMH, especially pertaining to the areas of human subject research protections, data and safety monitoring, and clinical trial operations.

Duties

Serve as a critical advisor for the Director of the Office of Clinical Research on clinical research issues with a particular focus on the design of clinical trials, the protection of participants in research, data and safety monitoring, and overall clinical trial operations. Assist the OCR Director in overseeing the continuous evaluation of NIMH's national and international efforts concerning all aspects of clinical research oversight and monitoring. In collaboration with the OCR Director, develop strategies to overcome unforeseen difficulties in clinical research studies with innovative solutions to ensure progress toward goals. Provide oversight for human research protections in clinical research protocols and during on-site quality assurance evaluations of NIMH-funded clinical research studies. Exercises responsibility, with the assistance of the Human Research Protection and Clinical Trials Operations Branch Chiefs, for the day- to-day operations of the Office, allowing the Director to pursue strategic priorities, clinical consultation, as well as allowing for the direct supervision of the immediate staff in the Office of the Director. Exercises full delegation of authority to act for the Director in all matters related to the operation of the Office and works directly with the Director to conduct continuous review and evaluation of the operations of the Office as they pertain to a broad program of grant and contract oversight activities. Participates fully with the Director, and other staff, as appropriate, in the oversight of fiscal and budget affairs, including the review and approval of budget justifications for each of the Branches within OCR. Stays abreast of current state of the-art research developments and participant safety regulations in order to serve as an expert resource to NIH staff and Extramural investigators. Conducts critical reviews and participates in the development of research initiatives as requested, with particular attention to the importance and timeliness of the study question, soundness of its rationale, adequacy of design, and feasibility with special emphasis on data and safety monitoring, human subject protections and ensuring the integrity of the research. Ensures that funded research is scientifically valid, ethical and complies with Institute/Center, NIH, and DHHS priorities. Formulates internal policies concerning Extramural research policy and priorities and advises management on the direction of research efforts. In conjunction with the Office Director, coordinates and integrates scientific activities with the NIMH Office of the Director, with other Institute and program officials, with other NIH and DHHS components with regard to the aspects of the programs that are of mutual interest and concern and with the various national and international agencies, national and international scientific societies, private foundations, and professional and lay organizations with common interest. Serves as the Office representative on NIH-wide and Institute-level scientific policymaking committees as assigned. Organizes and/or participates in symposia and discussions with national and international scientific leaders. Represents the Office and Institute at public or professional meetings relevant to the scientific programs supported by OCR and cross- Office/Divisional teams/initiatives/ programs of shared interest.

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 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).
• At the supervisor’s discretion, this position may offer work schedule flexibilities: telework (work from home on a regular basis or ad hoc basis but reports to the office at least once a week/two days a pay period), maxi-flexible schedules.
• This position requires: occasional travel.

Qualifications

Basic Education Requirement: Bachelor's or graduate/higher level degree: 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(external link) at the time the degree was obtained. In addition, in order to qualify for the Supervisory Health Science Policy Analyst, GS-0601-15 you must have (1) year of qualifying experience equivalent to at least the GS-14 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: managing clinical research programs on mental health or mental illnesses; providing guidance on laws, regulations, policies, and standards for the conduct of clinical research programs; managing resources for clinical research programs; coordinating and collaborating with other organizations on clinical research programs and projects; and providing supervision and direction to other staff. 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. 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. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12251399

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: Donna Baker
• Phone: 301-594-2283
• Email: [email protected]