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Summary The NIH CC Pharmacy is seeking an exceptionally talented, knowledgeable, and motivated Pharmacist for the Investigational Drug Control Unit (IDCU). The ideal candidate will have experience supporting clinical trials with protocol development and consultation, protocol review and investigational drug information, inventory management, record keeping, and quality assurance. Responsibilities Investigational drug development and clinical trials are important aspects of the NIH Clinical Center's research program. To support these research efforts, the Pharmacy Department is involved in the quality control, dispensing, and clinical monitoring of both non-investigational and investigational medications. As a GS-0660-13, Pharmacist with the NIH Clinical Center's Pharmacy Department Investigational Drug Control Unit, your duties will include but are not limited to the following: Attending site initiation visits, site qualifying visits and protocol start-up meetings as needed. Coordinating all activities related to the management of investigational drugs by the NIH Clinical Center. Researching the marketplace for commercial drug availability for use in the protocol, providing guidance to investigators regarding the availability of commercial drugs, and making recommendations on the need to obtain commercially available drugs. Identifying key projects related to investigational drug management and is accountable for coordinating the implementation of these projects system-wide. Identifying and providing pharmacy requirements related to products supplied by Contract Manufacturing Organizations (CMOs) and compounding pharmacies. Making authoritative determinations on conformance with requirements; and coordinating corrective actions or adjustments with the section reviewed. Acting as a liaison to other department representatives by informing and instructing them on the myriad aspects of protocol initiation and implementation. Researching up-to-date regulations and technologies to ensure the clinical trials and compliant and efficient. Requirements Conditions of Employment Qualifications To qualify for a Pharmacist (Investigation Drug Control Unit), GS-0660, you must have: A. A doctoral degree in Pharmacy that is recognized by the Accreditation Council for Pharmacy Education (ACPE) or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained; OR B. A bachelor's degree in Pharmacy and a substantial record of experience and achievement that demonstrates competence in the pharmacy field. Individuals who qualify based on this option will be subject to a comprehensive evaluation of both their education and experience prior to final appointment. AND License: An active current license as a pharmacist in a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. ADDITIONAL QUALIFICATIONS: In addition, in order to qualify for a Pharmacist (IDCU), GS-0660 at the GS-13 level, you must have at least one year of professional pharmacy experience equivalent to at least the GS-12 level in the Federal Government obtained in either the private or public sector, performing the following types of tasks: providing recommendations on the development and administration of internal surveillance and evaluations to assure conformance with plans and procedures; developing and implementing drug information activities and systems, modifying or adapting standard operating procedures; conducting literature evaluation, formulation of recommendations and initiatives, coordination of intervention strategies, and monitoring of study drug information activities; and offering advice on drug accountability aspects that are critical for investigators to be in compliance with applicable federal laws. 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. To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings with the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as knowing your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin before receiving an offer. Preview assessment questionnaire before you apply: https://apply.usastaffing.gov/ViewQuestionnaire/12532175 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 an "emergency essential" position and the selected candidate will be considered an "emergency essential" employee and will be required to be available, ready, willing, and able to report for duty under all circumstances (e.g., inclement weather, government closings and holidays, lapses in appropriations, non-emergency and emergency situations) for operation 24 hours a day and 365 days per year coverage. NIH may repay certain outstanding Federally insured student loans to facilitate the recruitment and retention of highly qualified people. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations. 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. A newly appointed or reappointed individual may receive a recruitment incentive. Recipients will be determined on a case-by-case basis based on organizational need, specific case justification, and budget limitations. A one-year probationary period may be required upon selection/placement. PHS Commissioned Officers interested in performing the duties of this position within the Commissioned Corps should also apply online to this announcement in order to receive consideration. 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. Visit our Total Compensation page and this sample for a detailed look into the benefits, awards, leave, retirement, and other incentives employees may receive as part of a rewarding work environment.