Position Objective: Provide services as a Clinical Operations Manager (Clinical Pharmacist) in support of the overall functions of the Division of Allergy, Immunology, and Transplantation (DAIT) within the National Institute of Allergy and Infectious Diseases (NIAID).

Duties and Responsibilities:

• Independently carry out diverse pharmacy functions to support DAIT Pharmacists with all aspects of clinical studies and the operations of the Investigational Product Procurement Center (IPPC).
• Provide operational support to DAIT Pharmacy Program Lead and Contracting Officer’s Representative (COR) with DAIT Clinical Product Center (CPC) contract and duties.
• Communicate with over 100 clinical sites gathering required information such as site Investigational Product (IP) inventories of expired and unexpired products for DAIT Pharmacist to evaluate, maintain and improve IP management.
• Perform IP procurement, receiving, transferring, tracking of cost savings and providing necessary documents to DAIT Pharmacy program lead, OPPOSI and grants management.
• Independently work with pharmacists in the development and/or review of pharmacy specific documents (e.g. Pharmacy Establishment Plans, Pharmacy Guidelines, Manual Templates and etc.) and standard operating procedures of relevance to DAIT Pharmacy Program activities.
• Independently review and approve Pharmacy Establishment Plans. This includes interacting with DAIT Pharmacist(s) and outside stakeholders.
• Create work flow and project management tools to track key milestones and/or identify potential problems associated with the review of Protocols, Pharmacy Manuals, Site Trainings, Pharmacy Establishment Plans (PEPs), Temperature Deviations, Drug Ordering and Shipments, Drug Purchasing & Approvals, Pharmacy forms processing and other study related projects and tasks.
• Create study-specific customized PDF fillable forms: Accountability record forms, IP order forms, IP return forms, IP destruction forms, Participants-specific treatment accountability record forms, and etc.
• In compliance with CFR 21 Part 11 and ICH E6 and GCP requirements and policies, they will assist DAIT Pharmacy program initiatives with all essential pharmacy documents that need to be sent to DAIT/NIAID Trial Master files.
• Independently work to maintain and update DAIT CPC monthly agenda and manage monthly meetings.
• Assist CPC COR with cost and financial tracking and updating relevant spread sheets.
• Serve as an information resource and managing SharePoint Pharmacy folders and point of contact for resolving user problems.
• Independently create quarterly Pharmacist assignment evaluation based on pharmacy and protocol prioritization at DAIT.
• Review site pharmacy monitoring reports and discuss any issues with Pharmacist(s) to note and create the resolution and action plan with the site pharmacist(s) and study team.
• Participate in site visits, as needed, to evaluate the facility, equipment, pharmacy personnel, and infrastructure capacity and provide report as needed.
• Participate in Division meetings and assist DAIT Pharmacy Programs with coverage for the DAIT/ NIAID Clinical Trials’ full group meetings and provide summaries as needed.
• Participate in protocol team or clinical research site conference calls with direction from DAIT pharmacist.
• Work with DAIT pharmacists in the development and formatting of protocol specific trainings for site pharmacists, which may include Power Point presentations, Manual of Operations and fillable PDF forms.
• Develop, review and revise processes and procedures for Pharmacy operations (e.g. SOPs, work instructions, guidance documents, etc.), in coordination with Pharmacy Program Lead.
• Edit, rewrite, and/or proofread drafts of materials prepared by DAIT pharmacists, as needed.
• Assis with data collection needed for ongoing pharmacy program initiatives quality assurance evaluation and internal audits.

Basic Qualifications:

• Bachelor’s degree in a health or science related discipline.
• Minimum of four (4) years of experience in clinical research or a related field.
• Certified Pharmacy Technician.
• Knowledge or proficiency with the implementation or utilization of USP Guidance Chapters <795>, <797>, and <800>.
• Knowledge of Good Pharmacy Practice, Good Clinical Practice, and Human Subjects Protection.
• Expertise in MS Office including Word, Excel, PDF, Outlook, and PowerPoint.

Minimum Qualifications:

• Hospital pharmacy experience preferred; however, retail pharmacy experience considered.
• Ability to work independently and display self-motivation in all aspects of work.
• Ability to function effectively and diplomatically as part of a team.
• Ability to identify issues that need special attention and bring those to DAIT Pharmacist(s).
• Proficient in communicating effectively orally and in writing.
• Excellent analytical, organizational and time management skills.
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
• Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.