This position is in the Clinical Research Operations and Management Branch (CROMB) of the Division of Extramural Activities (DEA), Extramural Program (EP), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The incumbent will be responsible for providing clinical research operations and management support, coordination, and resource planning for NIAMS extramural supported clinical studies.

Duties

Oversee the spectrum of clinical trials and other clinical studies supported in the extramural programs, working closely with research teams in research units across the U.S. Provide counsel and assistance in the recruitment and retention of study participants into clinical studies and advises the staff and develops specific recommendations regarding recruitment and retention strategies. Work with the NIAMS Clinical Team Lead and the Extramural Program Officials to identify major issues, trends and problem areas and provide technical expertise and consultation on issues related to the conduct, management and safety oversight of extramurally funded clinical studies. Implement policy to support for Data and Safety Monitoring Board (DSMB) meetings, reviews meeting materials, and works with DSMB members and NIAMS staff and the NIAMS contractor to review recommendations and minutes. Take a lead role in the formulation and execution of policies, guidance documents, and clinical study templates. Assess NIAMS-supported clinical research studies for adherence to new and existing NIH human subjects policies and regulations, and the standards for Good Clinical Practice (GCP).

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.)
• Position requires Education, please submit a copy of your transcript at time of application.
• 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.
• If selected, you will be required to complete a Confidential Financial Disclosure Report, OGE Form 450 to determine if a conflict or an appearance of a conflict exists between your financial interest and your prospective position with the agency.

Qualifications

Basic Qualifications: In order to qualify for a Clinical Coordinator, 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). AND You qualify at the GS-12 level, if you meet one of the following qualification requirements: You must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-11 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: writing scientific responses to inquiries, correspondence, reports and meeting materials pertaining to clinical research; ensuring the proper application of organizational guidelines involving clinical trials; disseminating the results of health research projects through summaries and reports; and presenting clinical research information, analyses, and proposals to various audiences. 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/12215972

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 Dr Bethesda, MD 20892 US
• Name: Lyubomyra Clendening
• Phone: 301-827-8117
• Email: [email protected]