Duties

• Provide pharmaceutical expertise in the development and implementation of standard operating procedures (SOPs) and policies for all pharmacy issues for the CCR's sponsored clinical research trials.
• Provide oversight and guidance to ensure that applicable laws, regulations, policies, procedures, and standards governing clinical pharmacology and drug therapy are followed in NCI Clinical Center protocols.
• Serve as a pharmacist on a multi-disciplinary team that oversees regulated cancer trials conducted under federal regulations, including clinical research, medical and radiological devices, biological products, or vaccines.
• Provide expertise and guidance on broad range of pharmacy issues related to sponsor and regulatory oversight.
• Participate in clinical trial protocol development and review. Provides comments regarding protocols to comply with OSRO Policies and Procedures, NIH Policies, and ICH Good Clinical Practice guidelines.
• Review clinical site monitoring reports for pharmacy/product issues and, if necessary, develops appropriate corrective action plans with the clinical site monitoring contractor and/or the site.

Requirements

Conditions of Employment

• 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 a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
• Applicants must meet all qualification requirements by the closing date of this announcement.
• Males born after December 31, 1959 must be registered with the Selective Service.
• Position requires Pharmacist License.
• Position requires Education. Please submit transcripts.
• Work may involve moderate risks or discomforts that require special safety precautions, e.g., exposure to contagious diseases or irritant chemicals.
• Must be able to distinguish basic colors.

Qualifications

BASIC REQUIREMENTS:

EDUCATION :
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.

LICENSURE :
Applicants must be licensed to practice pharmacy in a State, the District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.

ADDITIONAL REQUIREMENTS:
In addition to the above, in order to meet the Minimum Qualifications for a Pharmacist, GS-660 position 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: Overseeing regulated cancer trials conducted under federal regulations, including clinical research, medical and radiological devices, biological products, or vaccines. Providing oversight and guidance of applicable laws, regulations, policies, procedures, and standards governing clinical pharmacology and drug therapy. Providing training and guidance to clinical site staff about pharmacy issues, product issues, and protocol procedures and compliance with regulatory and good clinical practice standards. Reviewing clinical site monitoring reports for pharmacy/product issues and develops appropriate corrective action plans. Utilizes broad written and verbal communication skills to carry out work activities.

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/11714079

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

If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application .

• 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.
• Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine. Employees providing healthcare or services in support of healthcare (Healthcare Workforce) may be required to receive a COVID-19 vaccine because they are expected to perform duties that put them in contact or potential contact with patients. We may request COVID-19 vaccination, and other vaccination documentation from Healthcare Workforce personnel at any point during the onboarding process or at any time during your employment with NIH.
• 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.
• 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.
• 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.