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Summary This position is a Clinical Trials Program Coordinator and is responsible for ensuring the highest level of quality assurance and control for clinical research and should have specialized knowledge of mental health clinical trials research, good clinical practice regulations, project administration, and project management acquired from extensive experience in the conduct, implementation and oversight of single and multisite clinical trials. Responsibilities Develop and implement guidelines and standards for the conduct of clinical trials in order to ensure data quality, participant safety, and compliance with regulatory requirements for clinical research. Develop and implement project management plans, study monitoring plans and manage and coordinate the risk-based audit/monitoring of clinical research studies including on-site monitoring of clinical trials coordinating centers and/or clinical sites. Provide expert leadership through ongoing interactions with NIMH staff, principal investigators, and study staff. Develop and implement well-designed, effective informatics tools and procedures to evaluate clinical trial progress and conducts risk-based evaluations. Participate in meetings and serves as the NIMH representative and expert in clinical trials management conduct and oversight. Requirements Conditions of Employment Qualifications In order to qualify for a Clinical Trials Program Coordinator, GS-601, 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 a Clinical Trials Program Coordinator, GS-0601 at the GS-14 level, you must: demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-13 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: managing quality assurance and control for clinical research programs; developing and implementing guidelines and standards for the conduct of clinical trials; provide guidance to research staff on regulations, policies, and procedures governing the conduct of clinical trials; monitoring clinical research projects and documentation; reviewing clinical protocols, consent documents, and study forms; developing systems to oversee the management and efficiency of clinical research projects; and coordinating clinical trials with other scientists, staff, and organizations 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/12028727 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. Additional Information This position is designated as a "non-emergency/teleworker" position and the selected candidate will be considered a "non-emergency/teleworker" employee. In the event of a closure, you must be available to telework or request leave. "This position is eligible for local remote work, a position designation where onsite presence is required only on an irregular or infrequent basis, not to exceed two days or 16 hours every two weeks. Your worksite (e.g., home residence) must be within the Washington-Baltimore-Arlington pay locality to be eligible. Visit OPM's page for pay locality definitions. Visit NIH's Remote Work page for more information and requirements." A one-year probationary period may be required upon selection/placement. This position is eligible for remote work, a position designation where little to no onsite presence is required (e.g., once or twice annually). You may work anywhere in the U.S., including any of the territories. Worksites outside of the U.S. are prohibited. Your pay is determined by the geographically defined pay locality applicable to your approved worksite (e.g., home residence). Reporting to an NIH location may be required during the onboarding process. Visit NIH's Remote Work page for more information and requirements. At the supervisor's discretion, this position may offer work schedule flexibilities: [flexible schedules] A newly appointed or reappointed employee may receive service credit for prior work experience or active duty uniformed service that otherwise would not be creditable for the purpose of determining his or her annual leave accrual rate. All creditable service must be directly related to the duties of the position being filled and decisions to allow for such credit must be finalized prior to the selectee's entrance on duty. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations. PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should apply online to this announcement to receive consideration We may make additional selections for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s). Clearance of CTAP/ICTAP will be applied for similar positions. The National Institutes of Health participates in the USCIS Electronic Employment Eligibility Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of new hires and the validity of their Social Security numbers. The NIH maintains a tobacco free work environment and campus. Must be able to perform the essential duties of the position, with or without reasonable accommodation. Visit our Applicant FAQs page for helpful information on the application process. 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